Establishment, import & distribution by country

Import and export of devices are performed by the authorized/licensed wholesale traders; the Ministry of Health sends the General Directorate of Customs the list of wholesale traders and updates; AKBPM sends the device register and monthly updates (by the 20th of each month) to Customs.

Entities importing class II and III devices already registered in the National Register must submit an electronic self declaration within 10 days of release for free circulation of each registered device, stating imported quantity, series/lot and expiry dates; implemented through e Albania service No. 15366 (free of charge); failure to declare is fined 100,000 lekë.

Domestic manufacture of devices requires a licence: application via the National Business Center; conditions include self declaration of essential requirements and safety, dedicated production premises of at least 100 m2 plus at least 50 m2 for labelling/storage/distribution, a responsible person for the production line holding a second cycle degree in biomedical/clinical/electronic/electrical/chemical/physical/mechanical engineering or medicine/dentistry/pharmacy with at least 3 years' experience; verification by physical inspection within 25 days, recommendation within 5 days, publication of the minister's decision within 30 days; the licence has no expiry.

Wholesale of devices is carried out only by licensed legal persons. Licensing conditions (VKM 227/2022): an employed responsible person qualified by risk class (class I: first cycle degree + 1 year; class IIa: second cycle degree + 1 year; class IIb/III/IVD/AIMD: second cycle degree + 3 years), premises of at least 100 m2 (reception/sale, storage, recalled products areas) and internal rules on storage conditions; application via the National Business Center; physical inspection verification within 25 days, recommendation to the minister within 5 days, minister's decision published in the National Register of Licences within 30 days; the licence has no expiry date; appeal per Article 30 of Law 10081/2009.

Import establishments for pharmaceutical products and medical devices require a ministerial agrément (under décret n° 21 82 of 23 February 2021); the agrément is issued for two years, renewable; applications are filed by the pharmacist technical director via secure electronic channel.

The agréé import establishment must keep purchase and sales documentation and submit an annual statement of import operations to the competent ministry services at the latest by 31 January of the following year, on a pre established template.

Where the import activity concerns medical devices, the establishment's premises must be fit for that activity and at least 90 m²; where it concerns both pharmaceutical products and devices simultaneously, premises must be at least 390 m² (pharmaceuticals alone: 300 m²).

The establishment's BPF (Buenas Prácticas de Fabricación) certificate and its habilitación certificate must be presented jointly: the authorized scope and its validity are determined by the BPF certificate, so presenting either document separately has no validity.

Since 6 August 2025 (Disposición ANMAT 4446/25), imports of Class I and II medical devices require an AVISO DE IMPORTACIÓN (sworn declaration import notice) filed in the BONITA system up to 48 hours after nationalization; the notice is free of charge and prior ANMAT import authorization for these classes was eliminated.

Class III and IV devices, all IVDs, temporary imports of medical devices, and samples of unregistered products (any class) still require prior ANMAT import authorization. Direct users (non profit healthcare establishments) may import any class through the TAD procedure.

Medical devices are imported into Armenia on the basis of an import (conformity) certificate issued by the authorised body (Ministry of Health) (para. 2); the certificate lapses after customs clearance (para. 6). When devices are imported from an EAEU member state the importer moves them to its own warehouse, applies to the authorised body within 3 working days under the para. 9 procedure, and must not sell, distribute, release or use the imported devices before receiving the import (conformity) certificate (para. 9.1). Devices are imported under the EAEU HS codes listed in the table to the Decree and by name; goods under a listed HS code that are not medical devices are not subject to certification, in which case the importer declares that the product is not a medical device (paras 3 4). Import of used medical devices is prohibited, except devices whose conformity to the manufacturer's safety, quality and effectiveness parameters is certified only by the documents in Annex No. 2 para. 2(1)(a) and 2(2)(c) and whose period from manufacture to import does not exceed 5 years (para. 4.1).

The manufacture of medical devices, other than devices belonging to risk class 1, is carried out by legal entities or individual entrepreneurs holding a medical device manufacture licence under the Law on Licensing (Art. 47.1(1)). The licence is granted by the authorised body on the basis of an expert conclusion, and a state duty is charged for it (Art. 47.1(2) (3)). Installation, repair, technical and metrological servicing of medical devices (other than class 1 devices) are likewise carried out under a servicing licence granted by the authorised body on the basis of an expert conclusion (Art. 47.4(1), (3) (4)); persons holding servicing competence from the manufacturing company, or having the status of the manufacturer's official representative in Armenia, may service the equipment that manufacturer produced without a servicing licence (Art. 47.4(2)). Both licence requirements enter into force only once the respective Government licensing procedure enters into force (ARLIS notes to Arts 47.1(1) and 47.4(1), per Art. 3(7) and 3(8) of Law HO 304 N of 06.07.2022).

Every sponsor must apply to the TGA to have its imported medical devices included in the ARTG, even when another sponsor already has an ARTG entry for the same device; there is no separate importer licence regime — the sponsor's ARTG inclusion authorises import and supply.

Importers and distributors who consider or have reason to believe that a device they placed on the market in Austria poses a serious risk or is a falsified product must immediately inform BASG (contact by email to medizinprodukte@basg.gv.at) as well as the manufacturer and, where applicable, his authorised representative and the importer.

Import of a medical device into Azerbaijan is an authorisation, not a notification. Article 9 1.9 of the Law on Medicinal Products sets a device specific document set: where medical devices are imported, the following documents are added to the application — (9 1.9.1) a copy of the extract from the state register of legal persons where the applicant is a legal person, or a copy of the identity document where the applicant is an individual entrepreneur; (9 1.9.2) a copy of the certificate of registration of the applicant as a taxpayer; (9 1.9.3) a copy of the document confirming the applicant's right of ownership, use or lease over the facilities (warehouses, sites) at which the import of the medical devices named in the application will be carried out; (9 1.9.4) a notarised copy of the sale purchase contract for the imported medical devices (and, where the contract is in a foreign language, also its notarised translation into Azerbaijani); (9 1.9.5) a copy of the paper and electronic invoice (and, where the invoice does not reflect them, also the information provided by the manufacturer (seller) on the full name, serial number and service life or shelf life of each imported medical device); (9 1.9.6) a copy of the document reflecting the results of the manufacturer's quality indicators confirming that each batch of devices conforms to its specification; (9 1.9.7) a copy of the certificate of origin. Used medical devices additionally require the manufacturer's (seller's) document on their serviceability (article 9 1.10). Article 9 1.12 requires the authorising body to decide, in respect of medical devices, within the period set by article 19.9 of the Law on Licences and Permits (23 working days, or 13 on a simplified expertise, is the period for medicinal products). A local storage or handling establishment is therefore a precondition of the import authorisation, evidenced by a right of ownership, use or lease over the warehouse or site. The pharmaceutical activity licensing regime of article 5 (manufacture, wholesale and retail of medicinal products) is not a device requirement: article 1 1 excludes article 5 from the device equivalence clause, and the device document set in article 9 1.9 contains no wholesale pharmacy licence, in contrast with the licence required for medicinal products by article 9 1.5.3.

Importation of medical devices into Bahrain requires NHRA pre approval granted through the OFOQ system operated by Customs Affairs. All medical devices under HS code ministry code 2251 must hold an online licence to clear customs, the request must be submitted before shipping, and importation must be carried out by an authorized representative from the legal manufacturer within its registered scope. Importation of used or refurbished devices is prohibited.

No person or entity may manufacture, sell, stock, distribute or display for sale any drug (including devices) without a licence from the Licensing Authority or beyond licence conditions; manufacturing a new project or expanding an ongoing project requires prior approval of the Licensing Authority.

Import of any drug (including devices) is prohibited without a licence or beyond licence conditions, and no registered drug may be imported without prior approval of the Licensing Authority; import of registered raw materials, packaging materials and semi finished drugs likewise requires prior approval.

Import into Belarus, production, sale and medical use are prohibited for: substandard, counterfeit and falsified devices; expired devices; unregistered devices (unless legislation or EAEU law provides otherwise); devices with suspended registration or suspended sale/use decisions; devices subject to a withdrawal decision or an official notification of non conformity requiring withdrawal.

'Circulation subjects' of medical products are legal entities and individual entrepreneurs registered in Belarus and representative offices of foreign organizations that conduct testing, expertise, registration, production, storage, transport, sale, installation, commissioning, medical use, maintenance, repair or destruction of medical products.

Since 28 May 2026, importers of medical devices must register in EUDAMED in the 'Actors' module. EUDAMED is the sole authentic source for actor data of manufacturers, authorised representatives and importers; the FAMHP web portal database automatically retrieves these data, so it is no longer necessary for importers to register on the FAMHP web portal.

statement: Legal representation of the manufacturer is not a document included in each registration dossier: it must have been filed beforehand with the Área de Vigilancia y Control as a prior step, after which a simple photocopy is added to the company file. No consular legalisation is required for this document. · article: Numeral 2.3.4

A legal or natural person engaged in retail of medical devices in specialised medical device shops may procure medical devices only from wholesalers of medical devices, or from a manufacturer entered in the register kept by the Agency, and may market a device only if it is entered in the register of medical devices with the Agency. Conditions concerning premises, equipment and personnel for retail are prescribed by the Entities or Brčko District.

A legal entity engaged in the wholesale distribution of medical devices must, before starting that activity, register its activity with the Agency, which considers the application and keeps the register of legal entities engaged in the wholesale distribution of medical devices. Wholesale distribution of medical devices comprises procurement, storage, transport and sale of medical devices, including import and export.

A legal entity engaged in wholesale distribution must employ a responsible person with at least level VI of medical education who is charged with monitoring and reporting undesirable occurrences in the application of medical devices and responding to them, that is with materiovigilance, and must also employ a responsible person for the distribution of medical devices with adequate knowledge to take on that responsibility. It must additionally carry on its activity with a quality assurance system and protection of public health in place; the detailed good distribution practice conditions are set by the separate Ordinance on Good Distribution Practice (Sl. glasnik BiH 75/18).

From 1 April 2025 BoMRA replaced listing of medical device establishments with formal licensing: all local manufacturers, wholesalers, importers and distributors must hold a valid BoMRA licence, and from the same date mandatory permits and import fees are required for every consignment of medical devices and IVDs entering or leaving Botswana via the BRIMS portal.

BoMRA's public notice of 4 September 2026 lists product categories that are currently out of regulatory scope and do not require BoMRA import clearance, permits or registration: industrial use PPE, external quality assessment and proficiency testing materials, general non clinical laboratory equipment, devices solely for academic or experimental use, medical training equipment and simulators, general wellness and fitness devices not intended for clinical diagnosis, breathalysers and screening equipment not intended for clinical diagnostic procedures, spare parts and accessories for repairing existing equipment, and forensic/law enforcement test kits.

BoMRA states that for the import of medical devices into Botswana, registration of the product and an import licence are mandatory, and that the main requirements for import or export control include identification of a local representative, a market authorisation certificate from the country of origin, an import/export licence from BoMRA (or an import licence from the competent authority in the importing country), and registration of the product.

Manufacturers or importers of custom made devices must hold an Autorização de Funcionamento (AFE) from ANVISA and sanitary licensing (licenciamento sanitário) from the local sanitary surveillance authority, under Lei 6.360/1976.

The Royal Customs and Excise Department's table of goods requiring an import permit from a responsible agency contains no row for medical devices, medical equipment, surgical instruments or diagnostic kits. The only Ministry of Health Pharmaceutical Services category is 'Medicines, Herbal, Cosmetics', whose tariff list (HSC K) covers chapters 27 to 38 only and contains no heading of chapter 90 or headings 3005, 3006 or 4015. General (non radiating, non radio) medical devices are therefore imported on an ordinary customs declaration without a health agency permit.

The Department of Pharmaceutical Services' licensing guideline states that all medicinal products are regulated under the Medicines Order, 2007, that the Import Licence and Wholesaler's Licence are required for the importation, storage and supply of medicinal products, and that the licence authorises the import, storage and wholesale of registered medicinal products. No establishment licence, import licence or wholesale licence is required for a medical device importer or distributor.

The customs list HSC N designates every tariff line of heading 9022, including computed tomography apparatus, dental X ray apparatus, other X ray apparatus for medical, surgical or veterinary uses, and X ray tubes, as controlled/restricted goods whose import permit is issued by RSQU (EIDPMO), the Radiation Safety and Quality Unit under the Prime Minister's Office.

The wholesale permit application to BDA includes: the company unified identification code (ЕИК); a list of device categories according to the БДС EN ISO 15225 nomenclature system; a declaration covering the storage premises and the responsible manager; and a document for the paid fee.

Wholesale trade in medical devices in Bulgaria requires a wholesale trade permit (разрешение за търговия на едро) from ИАЛ (BDA) or another document certifying the right to trade medical devices issued by the competent authority of the relevant (EEA) state; Bulgarian manufacturers trading their own products are exempt.

Cambodia’s National Trade Repository records Prakas No. 1258 as requiring Ministry of Health visa registration for all medical equipment, including imports, and attachment of GMP or ISO certification to the visa registration application.

Exempt from holding an MDEL: retailers (including Class I manufacturers selling solely to end users); healthcare facilities; Class II IV manufacturers selling only their own licensed or Part 2/Part 3 devices; Class I manufacturers importing or distributing solely through an MDEL holder; dispensers; personal use importers; sellers of animal use only devices (label must state animal use); sellers of only custom made, special access or investigational devices; exporters under Food and Drugs Act s.37; and storage only warehouses.

No person may import or sell a medical device in Canada unless they hold a Medical Device Establishment Licence, except where exempted; MDELs cover importers and distributors of all classes and Class I manufacturers, and are issued by the Regulatory Operations and Enforcement Branch on the basis of signed attestations verified at inspection.

Customs clearance (destinaciones aduaneras) of devices under this regime is performed with certificates from the respective Servicio de Salud, in accordance with Law N°18.164, and their use and disposition must be authorized by ISP.

To obtain the Customs Destination Certificate (CDA) in the GICONA system, the requesting company must have a warehouse with sanitary authorization granted either by the Seremi de Salud (regional health authority) or by ISP; warehouse entry into GICONA is processed via giconaprocesos@ispch.cl. A specific prestación covers authorization of installation, operation or modification of device storage warehouses (catalog code 9200007).

Distribution controls are tiered: operating Class II devices requires filing (备案) with the municipal drug regulatory department; operating Class III devices requires an operation license (经营许可) from the same municipal department.

Manufacturing Class II or III devices requires a production license (生产许可) applied for from the provincial drug regulatory department, supported by evidence of GMP compliance and the device registration certificate.

All importing and marketing establishments for medical devices must meet storage and conditioning capacity requirements (set by the Health Ministry); INVIMA issues the Certificado de Capacidad de Almacenamiento y Acondicionamiento (CCAA) and verifies compliance through periodic visits.

Used biomedical equipment may be imported/acquired/donated only in classes I or IIa (treated as tecnología controlada), with a manufacturer/importer certificate that equipment is not more than 5 years from manufacture and in optimal operating condition, plus serial number and manufacture date; used class IIb/III equipment is prohibited. Refurbished (repotenciado) equipment of all classes may enter with a good functioning certification from the legal manufacturer or its representative.

The manufacturer (for domestically manufactured products) or the importer (for foreign products) must hold a valid sanitary operating permit (permiso sanitario de funcionamiento) matching its activity; the importer is defined as a person entering the country EMB manufactured abroad holding the respective valid operating permit. For national products the permit must state 'fabricación de Equipo y Material Biomédico' as activity.

Personal use in vitro diagnostic EMB may only be sold by mail order or telematic procedures through establishments holding a Ministry of Health permit for their commercialization.

Manufacture, import, export, distribution and sale of medical devices are conditional on an authorisation issued by the competent national authority; the conditions for granting a manufacturing, import, export, distribution and sale authorisation are specified by the competent authority of each UEMOA member state. In Côte d'Ivoire that competent authority is the AIRP.

Before starting wholesale or retail trade in medical devices or in vitro diagnostic medical devices, distributors must be entered in the Croatian register of distributors. HALMED decides on the entry within 30 days of receiving a complete request; no appeal lies against the decision, but an administrative dispute may be initiated. The obligation does not extend to persons authorised to carry out pharmacy activity under a separate law.

HALMED states that importers — any natural or legal person established in the European Union that places a device from a third country on the Union market — are not entered in the Croatian register of distributors, but are obliged to register in EUDAMED and are issued a unique registration number (SRN). An importer that also distributes medical devices within the EU must, in addition to EUDAMED, be entered in the distributor register. Operators previously entered in the register of medical device wholesalers that wish to continue importing devices from third countries must register in EUDAMED as an importer.

For inscription as a device importer, the applicant files the Anexo III form at CECMED's reception department together with, among other items, the document accrediting it as an importer issued by the Cámara de Comercio de Cuba, the nomenclature of products authorized to import, third party QMS certifications if held, and declarations of procedures for import activities.

Manufacturers, suministradores and importadores intending to introduce devices into the Sistema Nacional de Salud must be inscribed with CECMED; this is an indispensable prerequisite prior to any device registration application, and the inscription is valid for up to two years. Reinscription applications must be filed during the 45 natural days before expiry, and CECMED re evaluates the same requirements. Forms: Anexo I (fabricantes), Anexo II (suministradores), Anexo III (importadores).

Before making a device available on the Cypriot market, a distributor must verify that the device complies with the MDR/IVDR, check that an imported device carries the importer's details as required, check that the device bears the appropriate marking under the MDR/IVDR, and ensure that while the device is under its responsibility the storage or transport conditions meet the terms set by the manufacturer — a requirement CYMDA says concerns all the economic operators involved.

A device imported into Cyprus and placed on the market for the first time is compliant as regards labelling only if, in addition to the manufacturer's marking under MDR Annex I point 23.1 / IVDR Annex I point 20.2, the importer's name, registered trade name or registered trade mark, registered place of business and address appear on the device, on its packaging or in a document accompanying it. Any additional labelling must not cover any of the information provided by the manufacturer.

Ministry of Health position (statement of 14 August 2025): a medical device cannot be used within the scope of an ordinary trade licence business (živnost) — e.g. teeth whitening services with a device; such services constitute healthcare provision subject to the healthcare services regime.

Obligations for device use in healthcare (parts seven, eight and nine of Act 375/2022 Sb.: use, servicing, vigilance) apply analogously to persons providing services other than health services by means of devices — e.g. cosmetic or beauty businesses using devices.

Servicing of devices, except class I devices and class A IVDs, may be performed only by a person notified to SÚKL under § 23 (except the manufacturer's own procedure under § 44(3)); servicing of devices with a measuring function must comply with the metrology legislation.

Reprocessing of single use devices is prohibited in the Czech Republic, and the placing on the market, supply and use of reprocessed single use devices on Czech territory is prohibited. This is stricter than the MDR Art. 17 option allowing Member States to permit reprocessing.

IVD devices intended for detection of HIV infection (HIV type 1 or 2) may only be sold to private persons at pharmacies, including pharmacy branches and pharmacy outlets.

statement: Opening, relocating or renewing a distributor requires an evaluation and inspection by DIGEMAPS' Dirección de Vigilancia Sanitaria leading to a habilitation certificate; the file must be signed by the owner or legal representative and by a technical director who is a qualified pharmaceutical professional, whose academic title and exequatur certification must be filed, together with the company's commercial registry, tax registration, title deed or notarised lease, articles of association and premises plans and photographs. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

Establishments that store, distribute and/or transport medical devices must hold certification of buenas prácticas de almacenamiento, distribución y/o transporte under the applicable norm (Resolución ARCSA DE 002 2020 LDCL, whose definitions for casas de representación and distribuidoras are reformed by the 2026 device norm).

Establishments that manufacture, import, distribute, store or market devices and IVD reagents need a valid permiso de funcionamiento issued by ARCSA and may only perform the activities authorized in it; under the Ley Orgánica de Salud the permit is valid for one calendar year, and casas de representación and distribuidoras of devices require a permit from the national health authority (LOS Art. 179).

Imported devices may be conditioned (acondicionamiento) in Ecuador before marketing only in secondary packaging, and only where the establishment holds a valid device BPM certificate or an ARCSA registered ISO 13485 certificate and is declared as acondicionador in the registration; marking activities require a valid BPA/BPD/BPT certificate. Conditioning/marking must not affect product stability, integrity or primary container seal.

Companies may obtain an annual import plan through the Medical Devices Import Plans Unit (application and evaluation each within 3 working days); the plan is valid for one year from issuance and amendments are requested via the platform.

Importing medical devices requires an EDA import approval issued via the MeDevice platform, valid for one year from issuance; a customs release approval per invoice or annual plan is also needed. Newly registered devices are not released until their notification of registration is issued (two transition exceptions, each with one year for release).

Customs release covers registered devices, registration samples, raw material analysis samples, import approvals, annual plan devices and intragastric balloons; for import approvals and annual plans the company pledges that shipment invoices will not be opened unless an inspector from the Central Administration for Inspection on Pharmaceutical Institutions is present.

The import approval file must include the medical device importer's registration licence, added to the supplier or manufacturer based on the relationship letter.

Every undertaking that distributes on the Estonian market a system or procedure pack within the meaning of MDR Article 22, a class IIa, IIb or III medical device classified under Regulation (EU) 2017/745 or under Directive 90/385/EEC or 93/42/EEC, or a class B, C or D in vitro diagnostic medical device classified under IVDR Annex VIII, must notify Ravimiamet within ten days of the first distribution of that device. Ravimiamet states that notification of class I and class A devices is recommended but not mandatory.

Manufacturers or their authorised representatives, importers, distributors, professional users and lay users of medical devices, sellers and lessors of aids, and Tervisekassa submit data to the Estonian medical devices and aids database (meditsiiniseadmete ja abivahendite andmekogu, MSA); Ravimiamet is the controller of the database. The database holds data on placing custom made devices, systems and procedure packs on the market, on the distribution of devices in Estonia, on incident registration, on investigations and on supervision proceedings.

The device good storage and distribution guideline applies to all parties in the medical device supply chain in Ethiopia, including manufacturers, importers, wholesalers and retail outlets. Firms must ensure that medical devices are only sold or distributed to persons or entities authorised to acquire them, and must retain copies of written proof of that authorisation or of the special permit obtained before distributing to them. Records of dispatch must contain sufficient information to enable traceability of the devices and to facilitate the recall of a batch. Distribution and storage facilities are subject to inspection by the Authority's inspectors, at periodic intervals or as a surprise visit, and the inspected firm must submit CAPA for the reported non compliances within the period requested by the inspectors but not exceeding one month from receipt of the report.

Any person who wants to import, export or wholesale medicine and medical device in Ethiopia must first obtain a certificate of competence from the Ethiopian Food and Drug Authority. Directive No. 872/2022 applies to medicine and medical device importers, exporters and wholesalers, and its licensing rules are drafted for both product types together rather than for medicines alone. The application is made on the form prescribed by the Authority, with the appropriate service fee paid and the original supporting documents submitted online through the electronic regulatory information system at ilicense.efda.gov.et; the supporting documents include the educational evidence, employment agreement or contract and working experience letter of the technical manager and the store manager. A licence holder that wants an additional warehouse must meet the store manager requirements and have the new information written on the original certificate of competence, while opening a branch requires fulfilling all the requirements. A person may have only one import licence but may operate wholesale distribution branches at different sites in the country. The certificate of competence is renewed annually, and it is displayed at the technical premises and returned when it lapses. Article 23(1) of Proclamation No. 1112/2019 separately prohibits engaging in medical device trade without registration and licensing by the competent organ.

Importers and institutions intending to import medical devices must apply online for a purchase order or pre import permit through the eRIS system, uploading the proforma invoice, supporting letter as applicable, GMP certificate and donation certificate where relevant. The import permit is valid for twelve months, is not transferable and may cover one or more shipments, including partial shipments; once it has expired or been cancelled no further importation or supply at any quantity is permitted. For all imported medical devices the port of entry requires, among the administrative documents, a valid purchase order or pre import permit generated through eRIS or a hard copy authorised by the responsible EFDA directorate, a valid registration certificate, and a certificate of competency (COC).

Importers must indicate their name, registered trade name/trade mark, place of business and contact address on the device or packaging or an accompanying document; must verify the device is registered under Art. 29; and must add their own details to the registration per Art. 31 (i.e. EUDAMED registration with SRN) (Art. 13(3) (4) MDR). Importers must keep a register of complaints, non conforming devices and recalls (Art. 13(6)).

Before placing a device on the market, importers must verify: (a) CE marking and that the EU declaration of conformity has been drawn up; (b) a manufacturer is identified and an authorised representative designated under Art. 11; (c) the device is labelled and accompanied by required instructions for use; (d) where applicable, a UDI has been assigned. Non conforming devices must not be placed on the market; serious risk or falsification must be reported to the competent authority (Art. 13(1) (2) MDR). No EU level importer licence exists; the role is duty based.

Importer and authorised representative obligations under MDR/IVDR apply also when placing legacy AIMDD/MDD/IVDD compliant devices on the market under MDR Art. 120(3)/IVDR Art. 110(3); distributor obligations apply correspondingly when making such devices available under Art. 120(4)/110(4).

Declarants must report any change to the initial declaration without delay, confirm the accuracy of the data one year after registration of the initial declaration and then every two years, and declare cessation of activity or SIRET change; an incomplete declaration must be completed within 30 days or it is deemed inadmissible. The form, deadlines and filing rules are set by decision of the ANSM Director General.

Placing on the market, or making available on the market, a product that does not comply with the requirements established for it by Georgian legislation and that does not pose a threat to human life, health, property or the environment is an administrative offence punishable by a fine of GEL 1 000; the same act committed by the manufacturer, the authorised representative or the importer is punishable by a fine of GEL 1 500. Where the product poses a threat the fines are GEL 2 000 and, for the manufacturer, authorised representative or importer, GEL 3 000; where it poses a serious threat they are GEL 3 000 and GEL 4 000. Failure of an economic operator to provide the Agency with information required by Georgian legislation is punishable by a fine of GEL 500, and a repeat of any of these offences within one calendar year is punishable by double the respective amount. The case is examined by the Market Surveillance Agency, and its resolution — like a resolution on suspension of sale, withdrawal or recall — is appealed in the general courts of Georgia.

An economic operator — a manufacturer, authorised representative, importer, distributor or the person supplying the product directly to the user, as defined by Article 4 of the Code — must meet the product safety and placing on the market requirements of Georgian legislation, and in the process of market surveillance must cooperate with the Market Surveillance Agency and give its representative access to the places of production, warehousing, storage and sale of products. When placing a product on the market or ensuring its availability the operator must ensure that the product complies with the requirements of the relevant technical regulation and that the relevant technical documentation has been prepared, and must keep that documentation for the period set by the same technical regulation for the purpose of submitting it to the Agency. The operator must indicate its own name, registered trade name or registered trademark, and contact information including its postal address, on the product, on its packaging or in the accompanying documentation. On the Agency's request it must supply the documents and information relating to the product determined by Georgian legislation, including information about the economic operators in the product's supply chain on the market. If it has information or a well founded suspicion that a product it has made available on the market does not comply, it must immediately take all necessary corrective action as a voluntary measure; if the product carries a risk it must immediately notify the Agency and provide relevant information including on the non compliance and on all corrective action taken. A manufacturer must not distribute any product that, to the best of its knowledge and belief, fails to comply with the mandatory safety requirements, and a manufacturer and a distributor must within their competence cooperate with the authorised bodies on the safety of products placed or intended to be placed on the market.

A device reaches the Georgian market through the operator roles defined in Article 4 of the Code of Georgia on Product Safety and Free Movement, in the wording substituted by Law of Georgia No 1447 of 1 April 2026 with effect from 1 June 2026. A manufacturer is any natural or legal person that manufactures a product or places it on the market under its own name or its own trademark. A distributor is any natural or legal person in the supply chain that, within the scope of its activity, supplies the market with products and is not a manufacturer or an importer. An authorised representative is a natural or legal person authorised by the manufacturer, acting on the basis of a written power of attorney issued by the manufacturer, in the manufacturer's name, in order to perform the obligations determined by the Code and/or the relevant technical regulation; an authorised person may address the authorised representative instead of the manufacturer in relation to the requirements of the technical regulation. The importer / person responsible for placing the product on the market is the person responsible for placing on the market products manufactured in another country. 'Placing on the market' is the first making available of a product on the territory of Georgia, except for the free industrial zones, including through import, for commercial and/or non commercial purposes; 'making available on the market' is any supply of a product on the territory of Georgia in the course of a commercial activity, for distribution or use/consumption, for payment or free of charge. Supplying a product to the manufacturer's own representation is expressly not placing on the market.

The Revenue Service — the Legal Entity under Public Law within the system of the Ministry of Finance of Georgia — is the border actor in Georgia's product safety regime. If it has information about a product being brought into Georgian territory in relation to which there is a confirmed risk, it must take every possible measure to prevent that product from being brought into Georgian territory and must immediately notify the Market Surveillance Agency so that market surveillance measures can be carried out. To carry out market surveillance measures, where there is a well founded suspicion or on the basis of risk analysis, the Agency may ask the Revenue Service to suspend a product; the Revenue Service must suspend the product for the period determined by Georgian legislation for product inspection and must not allow that product to be placed on the Georgian market by way of import. Where it is established that the product does not comply with the Code or the relevant technical regulation, or that there is a confirmed risk associated with it, the Revenue Service must not allow that product to be placed on the Georgian market by way of import.

Establishments that manufacture implantable custom made devices (Sonderanfertigungen) of class III must notify the competent authority before taking up the activity, stating their address, via the German medical device database (§ 86 MPDG); changes must be reported immediately.

Businesses that reprocess products intended for low germ or sterile use exclusively for others, and health institutions that reprocess single use products under MDR Art. 17(3) (or have them reprocessed), must notify the competent authority before taking up the activity, stating their address, electronically via the German medical device database (§ 86 MPDG); any change of the notified data must be reported immediately ('unverzüglich', § 4 Abs. 3).

All importers of medical devices are required to renew their company licence with the FDA annually.

Only companies duly registered by the Registrar General's Department and licensed by the FDA are permitted to import medical devices; the Medical Devices Department registers importers and reviews compliance with Good Distribution Practice (GDP) requirements.

Import permits must be granted before importation of a medical device; permits are presented to Customs (CEPS) once only and are valid for one calendar year from the date of issue. A processing fee is charged.

Only FDA registered medical devices may be imported; imported products are inspected by FDA officials at the approved port of entry before release to the importer.

Imported medical devices must have at least 60% of shelf life remaining on arrival; products with shelf life under 24 months must have at least 80% remaining.

Ministerial Decision ΔΥ8δ/Γ.Π.οικ./1348 (ΦΕΚ Β' 32/16 01 2004) sets national principles and guidelines of good distribution practice for medical devices ('Αρχές και κατευθυντήριες γραμμές ορθής πρακτικής διανομής Ι/Π'); it remains listed by EOF as applicable additional national legislation and is the basis for the distribution certificate held by distribution companies.

EOF administers national establishment licences for device production: granting of the 'Άδεια Δυνατότητας Παραγωγής Ιατροτεχνολογικών Προϊόντων' (EOF Circular 3172/14 01 2011), transfer of the production process (Circular 34357/21 05 2009), appointment of the responsible production person (Circular 46023/02 07 2010), certificate of lawful operation, and licence of capability to carry out checks; IVD manufacturing licences are also granted.

AG 712 99 Art. 71 enumerates twenty classes of establishment subject to sanitary licensing, among them 'Fábrica de material de curación y otros' (71.8), 'Fábrica de reactivos para diagnóstico' (71.9), 'Droguería' (71.11) and 'Distribuidora' (71.12). Article 72 makes a sanitary licence mandatory for all of them and subjects them to inspection by the DRCPFA.

A listed importer must retain records for not less than the projected service life of the device as defined by the manufacturer, or seven (7) years after the date the device is supplied to another person, whichever is longer.

Importers and local manufacturers of medical devices may apply to become Listed Importers or Listed Local Manufacturers under MDACS; distributors may be listed under GN 09. Trader listing is voluntary like device listing.

Since 23 March 2026 (Stage C enhanced measures), all applicable medical devices (Class II/III/IV GMDs and Class B/C/D IVDMDs) procured by the Department of Health must be listed under MDACS.

The distributor notification must state the data elements listed in 4/2009. (III. 17.) EüM rendelet 17. § (3) a)–g), including the basic UDI DI of each distributed device per MDR Annex VI Part C point 1.

Before a device is placed on the market or offered on the market, a distributor must verify that: (1) the device bears CE marking and an EU declaration of conformity has been drawn up for it; (2) the device is accompanied by the information the manufacturer provides under Article 10(11) of the Regulations; (3) for imported devices, the importer has met the requirements of Article 13(3) of the Regulations; and (4) the manufacturer has, where applicable, assigned a UDI. The distributor must otherwise meet the obligations in Article 14 of the Regulations.

Before offering a device on the market, an importer must verify that: (1) the device bears CE marking and an EU declaration of conformity has been drawn up for it; (2) the manufacturer is identified and has appointed an authorised representative in accordance with Article 11 of the Regulations; (3) the device is labelled in accordance with the Act and the Regulations and is accompanied by the required instructions for use; and (4) the manufacturer has, where applicable, assigned a UDI. The importer must otherwise meet the obligations set out in Article 13 of the Regulations. An importer may only place on the market devices that comply with the Regulations and the Act.

Iceland operates no import licence, no establishment permit and no device by device customs clearance for medical devices. Lyfjastofnun states that importation is conditional only on the device being lawful on the European market and in Iceland, and is otherwise free; and separately that it keeps no register of individual devices. Lyfjastofnun may nonetheless request information and data from other public authorities, including the customs authorities, irrespective of their duty of confidentiality, so customs data is a supervision input rather than a clearance step.

Any person selling, stocking, exhibiting or offering for sale or distributing devices must obtain a registration certificate: application in Form MD 41 to the State Licensing Authority, granted as Form MD 42 within ten days, subject to a self certificate of Good Distribution Compliance; the certificate is perpetual subject to five yearly retention fee (late grace up to six months at 2% per month).

A branch distributor licence requires: non individual business (PT/cooperative), PNBP payment, the head office's Izin DAK, the head office's CDAKB certificate, technical responsible person data, a statement to comply with CDAKB, with 1 year from OSS approval to fulfil the requirements; the branch licence validity follows the head office certificates.

Distribution of medical devices may only be performed by pharmaceutical management facilities, device producers, and device distributors holding a business licence (perizinan berusaha); distribution must follow Cara Distribusi yang Baik (CDB), and the CDB for devices is set by the Minister.

A device distributor (Distributor Alat Kesehatan) must be a limited company (PT) or cooperative and holds an Izin Distribusi Alat Kesehatan (Izin DAK/IDAK) under KBLI 46691. The business licence is valid 5 years and must be extended; the extension requires holding a CDAKB (GDPMD) certificate, and a full time technical responsible person (PJT) with CDAKB training certificate is required.

Import of devices/PKRT may proceed only after obtaining an izin edar from the Minister; imports are processed through an electronic system integrated with the Indonesia National Single Window (INSW). In special circumstances the Minister may issue an import certificate (surat keterangan impor) for devices/PKRT, and used (non new) devices may be imported for certain purposes subject to safety, benefit and quality requirements.

Distribution and retail of medical equipment require an establishment/activity permit under the directive 'دستورالعمل تأسیس و فعالیت شرکت‌های پخش، توزیع و عرضه تجهیزات و ملزومات پزشکی', plus a defined registration process for distributors/suppliers and storage under the storage and warehousing directive (دستورالعمل انبارش و نگهداری).

Under Article 47 of the medical equipment regulation, import of all used and second hand medical equipment for sale, use or consumption is prohibited. Devices refurbished by (or authorized by) the original manufacturer may be imported subject to issued directives and Technical Committee approval; the list of refurbishable items is set annually. No refurbished IVD device has ever been approved.

The KRG import license for medical devices and materials (issued by KMCA) requires a certified certificate of origin, a packing list, the purchase invoice, and a copy of the packaging artwork; the service condition references company registration at the KRG Ministry of Health.

Companies and scientific offices importing radioactive sources must first obtain an import authorization for radioactive sources from the National Authority for Nuclear, Radiological, Chemical and Biological Control, and then obtain the import license through the Ministry of Trade / General Company for Iraqi Exhibitions and Commercial Services.

Distributors established in Ireland who place medical devices (other than IVDs) on the market must notify HPRA of their name, registered place of business and the device category — a national registration duty going beyond MDR distributor obligations.

'Manufacturing facilities' in Ireland — entities that do not place devices on the market under their own name but manufacture devices or critical components, or carry out packaging or labelling activities — must notify HPRA in writing of the facility name and address and supply information on the device related activity.

AMAR issues one time import approvals (e.g. for use in a private clinic or for evaluation) and periodic (annual) import approvals; importing for marketing requires the product to be registered in the Medical Equipment Register. Currently no fee is required to obtain import approvals; import questions go to Amar.Importation@moh.health.gov.il.

From 8.2.2023, applications to import biological source materials intended for laboratory use only (not for use in humans) are approved on the basis of an importer declaration: a full application in the Maslul (מסלו"ל) system plus a signed importer declaration per the attached guide.

If the register registration is not renewed, the registration holder cannot obtain import approvals.

For devices offered by distance selling to the public online, the Ministry of Health is the authority competent to issue measures preventing access to internet addresses of websites identified as promoting illegal practices towards Italian users; urgent cessation orders under Art. 24(3) are executed by the Carabinieri Command for Health Protection (N.A.S.), with AGCM and AGCOM participating as observers in the conference of services.

A distributor making non custom medical devices available on the Italian territory must register in the national database (banca dati nazionale) operating at the Ministry of Health, conferring its own data and the identification of devices present in EUDAMED in conformity with the UDI system.

Distributors and importers performing relabeling/repackaging activities under MDR Art. 16(2)(a) (b) must confer to the Ministry of Health the information and documentation relating to the relabeled and repackaged devices.

Selling, granting, leasing (or displaying for such purposes) 高度管理医療機器 (Class III/IV) or 特定保守管理医療機器 requires a distribution or leasing license (販売業/貸与業許可); providing the equivalent device programs over telecommunication lines is equally covered.

An MAH importing devices/IVDs for marketing must, by the time of customs clearance, hold a document proving for each product that an approval or approval application, a notification, a foreign special approval (or application), or a certification (or application) exists.

Domestic entities manufacturing devices/IVDs as a business — including design — must register each applicable manufacturing site (design, assembly, sterilization or other Ordinance designated processes) with MHLW.

Adoption (approval) of manufacturing sites for medicines and for materials designated by the Higher Committee from Article 3(b) materials (which include devices and supplies) is a Higher Committee function under Law 12/2013.

Production, manufacture (customization), wholesale and retail realization of medical devices are types of pharmaceutical activity subject to licensing; production of unregistered devices and trade in unregistered devices are prohibited.

The state body in the sphere of circulation agrees import and export of both registered and unregistered medicines and medical devices.

Import of unregistered devices is allowed on the basis of a conclusion (permit document) for: clinical research; expertise for registration/re registration/amendments; medical care by vital indications of a specific patient or a limited cohort with rare/severe pathology; exhibitions without sale; humanitarian aid and emergencies; innovative medical technologies; UN organized supplies by the single distributor; components; and other listed cases.

Import of devices is allowed for: holders of a production licence; holders of a wholesale realization licence or entities included in the register of healthcare subjects performing wholesale of medical devices; research organizations for development/registration; foreign manufacturers (their representative offices or trusted persons) for registration expertise; healthcare organizations.

Manufacturers, importers and distributors of medical devices in Kenya are regulated through registration of medical device establishments under the Pharmacy and Poisons Act; establishments are expected to have an established quality management system (ISO 13485:2016) to ensure continued safety, quality and performance of devices throughout the product life cycle and supply chain. Applications are made via the PRIMS portal following the Guideline for Registration of Medical Devices Establishments.

Under sections 3A(e) and 3B(2)(e) of Cap. 244 the Board grants or revokes licences for the manufacture, importation, exportation, distribution and sale of medicinal substances. Import/export permits are applied for and evaluated through PPB's online system (products portal); health products and technologies must be imported through designated and gazetted ports, where the Ports of Entry unit verifies import/export documents and inspects consignments for Good Distribution Practice compliance.

A consignment of devices operating with non ionizing radiation that is listed in a customs declaration is released only with the approval of the Kuwait Ministry of Health. The service is filed by transferring the original customs transaction documents from the General Administration of Customs to the Ministry of Health. Two conditions attach: the importer must already hold an import licence for the devices to be released, and the entity that will use the devices must have applied for the device use licences and for the personal licences for the physicians who will operate them. Approval is granted by the Radiation Protection Department, which then writes to the General Administration of Customs. The fee is 5 KD per consignment, stated as 'إذن إفراج عن الإرسالية' (consignment release permit).

A company or establishment that imports a device operating with non ionizing radiation must obtain an import licence from the Kuwait Ministry of Health. The service page states the scope as devices used in the medical field, the industrial field, the research field, the veterinary field, the communications field, the entertainment field or any other field. The applicant must identify the importing entity and show that the entity that will use the device has the legal standing to use it for the purpose it is imported for, at its place of use and with a qualified operator. The application is filed as an official letter addressed to the Radiation Protection Department of the Ministry of Health naming the device type, the manufacturer, the model and the number of devices; the device is then classified under a ministerial decision, the required licence types are determined, the storage and installation site is inspected where a site licence is sought, and the licence is issued by the Radiation Protection Department after the matter is put to the Radiation Prevention Committee. The applicant must also hold an import licence from the Ministry of Commerce and Industry, and files the prescribed import licence application form.

statement: Distributors referred to in paragraph 29 may make medical devices available on the Latvian market only if information about them as distributors is entered in the LATMED database. From 1 January 2026, manufacturers, importers and distributors may supply devices for distribution only where the distributors making the devices available are listed in LATMED. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: Yes · targetDecisionRetained: No

statement: An importer operating in Latvia which considers, or has reason to consider, that a device it has imported and placed on the Latvian market presents a serious risk or is falsified must inform the Health Inspectorate and the State Agency of Medicines. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: No

statement: A distributor whose place of business is registered in Latvia and which makes medical devices available to healthcare institutions or healthcare professionals, or supplies them for distribution to other distributors, must file an application with the State Agency of Medicines before making the devices available. The application states the distributor's name, registration number, legal address, telephone and e mail, and the classification class plus the manufacturer's name and legal address of the devices it intends to make available. The agency enters the information in the LATMED database within 10 days. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: Yes · targetDecisionRetained: No

By Decision No. 1704/1 of 12 September 2017 the MOPH began mechanising the import invoices for implantable medical devices and applied the MED Import online system from 16 August 2017: all importers and distributors must upload the import invoices for these devices directly through the system, after confirming that every implantable item on the invoice is recorded with the Programs and Projects department. From 1 December 2017 the import department of the pharmacy service and the Health Engineering Service stop endorsing invoices that have not been uploaded into Med Import. Importers and distributors must also keep the conformity certificates of the devices recorded in the MEDREG registration system up to date, failing which Med Import refuses invoices for items whose certificates have expired.

To declare itself as a supplier of medical devices an establishment must be a company holding a commercial register number and must confirm its commitment to the manufacturers' traceability protocols and its involvement in market surveillance of products already in service by signing a consent. The MOPH assigns each declared supplier a user identifier and password giving access to the online device registration system, and the MOPH authorisation is given for one year, renewable.

The supplier declaration dossier filed with the MOPH must contain: (1) the supplier declaration sheet with the administrative data (whether the applicant is manufacturer, importer or distributor; activities and device categories marketed; company and legal representative contact details; for importers/distributors, the represented manufacturers and their contacts); (2) a certificate proving the supplier's registration on the Lebanese commercial register showing its principal activities; and (3) a consent signed by the supplier confirming adherence to the manufacturers' traceability protocols, involvement in market surveillance of marketed products and commitment to communicate any information relevant to safe use. Incomplete dossiers draw a request for complements with a response deadline; after data entry the supplier receives credentials for tele declaration of its products, and the access code changes at each annual renewal.

Whoever first imports into Liechtenstein, or places on the market there, IVDs that do not meet the requirements for moving into or placing on the market in Switzerland must report this to the Amt für Gesundheit; the Amt für Gesundheit keeps a register of these persons and informs them of their duties to give warnings (Art. 9) and keep records (Art. 10, three year retention).

Anyone supplying (for payment or free of charge) medical devices that do not meet the requirements for moving into or placing on the market in Switzerland must draw attention to the prohibition of commercial or private circumvention trade into Switzerland under Art. 9 of the Gesetz über die Verkehrsfähigkeit von Waren (EWR MepV Art. 8) and keep records containing the recipient name/address and date of supply for five years.

It is prohibited to place medical devices on the market outside trade premises and/or to distribute them to consumers; the ban does not apply to distance contract sales, vending machine distribution, and sales in healthcare institutions where the law so permits.

No registration is currently provided for distributors in Luxembourg — neither as economic operators nor for the devices they distribute — but this may change in the future. National language requirements must still be met for distributed devices.

An operation licence (經營准照) from ISAF is required to import/export and wholesale Class IIb and III devices and to retail Class IIb devices; retail of Class III devices is prohibited.

Manufacturing devices in Macau requires a manufacturing licence (製造准照) from ISAF: the manufacturer must hold an industrial licence for the premises and operate a quality management system conforming to medical device Good Manufacturing Practice; the licence is valid 3 years, renewable for equal periods. Contract manufacturing requires prior ISAF permission.

The operation licence is valid from the issue date to 31 December of the following year and is renewable annually; holders must submit a continuing compliance declaration every December.

No establishment may import, export or place on the market any registered medical device unless it holds an establishment licence; contravention is punishable with a fine up to RM200,000, imprisonment up to 3 years, or both.

An establishment licence is recorded in the Register for three years from the date of issue unless cancelled earlier.

MDA processes complete establishment licence applications within 14 21 working days.

An application for renewal of an establishment licence shall be made to the Authority not later than one year before its expiry, and additional information requested must be provided within 30 days; on renewal the licence is again recorded for three years.

From 1 July 2024 MDA implements the 'one licence for each establishment role' policy: new establishment licence applications are limited to one role (manufacturer, importer, distributor or authorised representative) per application, and at renewal multi role licence holders must keep one role in the renewed licence and separate the others via new licence applications.

No person may import, wholesale, manufacture or re purpose in Malta any medical device intended for trade within the European Union or the local market before obtaining all the approvals, authorisations, licences, permits and notifications required by S.L. 458.59 or any other law. An applicant must comply with the regulations and with all national and Union requirements, obtain the necessary authorisation from the competent authority, hold the qualifications and training the Authority requires, have a medical device registered person in Malta, and insert the details of every device it markets locally into the national medical device database kept by the Authority.

Establishments that do not require a sanitary licence must file an aviso de funcionamiento with the Secretaría de Salud (or state governments) at least 30 days before starting operations; for device registration holders this notice is a holding requirement (RIS Art. 181). Device factories and warehouses are not among the establishment types requiring a full sanitary licence under LGS Art. 198 (which lists narcotics processing, medicines/plaguicidas manufacture, plaguicide application and radiation sources).

Importing device inputs requires a prior sanitary import authorization; products requiring it that enter without the permit are deemed illegally introduced, triggering safety measures and sanctions. The import authorization has a maximum validity of 180 days, extendable once for an equal period if conditions are unchanged. Importers must keep import authorizations for at least three years and exhibit them to the authority on request.

For the same generic group of medical devices of a manufacturer, no more than one authorised representative may be designated; designation of several representatives is possible for clearly delimited device categories to the extent that the mandates do not overlap. Where a manufacturer designates a separate authorised representative for each generic device group, that mandate is accepted in writing and is valid exclusively for the products in those groups, and a letter issued by the manufacturer must be presented to AMDM specifying expressly the ranges, families or categories of devices and the representative responsible for them. Where overlapping mandates are identified, the examination of the application may be suspended for a period of at most 30 calendar days in order to clarify the extent and validity of the representation mandates.

Where the seat of the manufacturer that places a medical device on the market is not located on the territory of the Republic of Moldova, the manufacturer designates an authorised representative in the Republic of Moldova. The designation takes place by an agreement concluded between the manufacturer and its authorised representative; the agreement is concluded in the form of a contract specifying the obligations of the parties so that they ensure compliance with the regulations in force, and the manufacturer and the representative are free to determine its structure and content provided the minimum requirements annexed to the Procedure are met. For the CE route the representation agreement must be attached as a PDF signed by the parties and is the document on which the manufacturer registration application rests.

An application for the import supply special permit must be supported by an expert conclusion and evidence on whether the applicant's buildings and premises, their organisation and its human resources meet the conditions and requirements of the good storage and distribution practice standard (эм хадгалалт, түгээлтийн зохистой дадлын стандарт). The parallel condition for the manufacture export permit is the good manufacturing practice standard, plus documentation that production equipment meets its basic performance and safety requirements.

A legal entity may import and supply medical equipment, laboratory diagnostic devices and medical consumables only under an 'import supply special permit' (импортлох ханган нийлүүлэх тусгай зөвшөөрөл) granted on the decision of the special permit commission and valid for the period set by Article 2.2(1) of the Law on Permits and Notifications. Manufacture export is a separate permit (6.1.1) and retail sale a third (6.1.3). The import supply and manufacture export permits are granted, extended, suspended, restored and annulled by the state administrative body responsible for medicines and medical devices; the sale permit by the aimag or capital health department. A permit may not be sold, gifted, pledged or otherwise transferred.

A holder of the import supply special permit must supply medical devices at wholesale price to health organisations and pharmacies, and is prohibited from importing, supplying or distributing devices that are not registered or not entered in the state register, and from breaching the storage, distribution and transport regime specified by the manufacturer.

statement: An importer of a medical device from a non EU country may place on the market only a device for which conformity assessment has been carried out under the Law. Before placing the device on the market the importer must ensure that: the manufacturer carried out the conformity assessment procedure; the manufacturer authorised an authorised representative under the Law; the manufacturer prepared the declaration of conformity and technical documentation; the manufacturer assigned a UDI or bar code, where applicable; the device bears the conformity marking; and the device is labelled under the Law and accompanied by the instructions for use and the declaration of conformity. · udiRequired: Yes

statement: Import and export of medical devices may be carried out by domestic and foreign legal and natural persons entered in the register of importers kept by the Institute. The registration decision covers the device, the manufacturer, the legal person carrying out wholesale and retail trade and the importer. · importEstablishmentRequired: Yes

Any establishment manufacturing, importing, exporting, distributing or maintaining medical devices must be declared to the administration before starting activity. The declaration file must contain architectural plans and technical installation drawings conforming to good manufacturing, transport, storage and distribution practice; the list and qualifications of staff by function and post; an organisation chart dated and signed by the legal representative; a note indicating manufacturing and/or storage sites outside the establishment site and any delegated operations; company documents (commercial register entry, articles of association, appointment of the legal representative); and the name of the person responsible for materiovigilance within the establishment. Four copies are filed with the Direction du Médicament et de la Pharmacie, one of them electronic.

A medical device manufacturing licence application requires: application letter, company profile, product list and specifications, organisation set up, factory location map and layout plan, staff education/responsibilities, QC supervisor name and background, staff health certificates, machinery list with photos, manufacturing process with photos, QC procedures and tests, raw material supplier list and specifications, certificate of analysis for each product, labeling information, copy of company business licence, and copy of the old manufacturing licence for renewal cases.

Manufacturers, authorised representatives and importers must register through the electronic system (EUDAMED) and provide the Annex VI Part A Section 1 information before placing devices, other than custom made devices, on the market, obtaining a Single Registration Number; where the conformity assessment procedure requires a notified body, the information must be supplied before applying to it. Importers additionally bear the general obligations of Art. 13 (verify CE marking and EU declaration of conformity, ensure storage and transport conditions, register complaints).

New Zealand operates no establishment licence or importer authorisation scheme for medical devices: the import control is that a person in New Zealand who imports or arranges importation qualifies as the 'sponsor' and must comply with the WAND notification, declaration and update duties under the Database Regulations.

An original Clean Report of Inspection and Analysis (CRIA) is required for products coming from China and India, where applicable, as part of the port clearance package.

Imported medical devices are cleared at ports via https://ports.nafdac.gov.ng (PIDCARMS) with uploaded documents including SGD form, commercial invoice, PAAR, Form M, Bill of Lading/Airway Bill, packing list, Form C 30, letter of undertaking, evidence of valid NAFDAC product registration, and manufacturer Certificate of Analysis; the consignment undergoes joint inspection and two endorsements before e release.

NAFDAC will not entertain new applications for registration of imported regulated products on the Federal Government Import Prohibition List and the NAFDAC Ceiling List.

The Law defines circulation of medical devices as comprising import, export, wholesale and retail. Wholesale may be carried on only by a legal entity entered in the Agency's register of legal entities performing wholesale of medical devices, and the activity must be notified to the Agency and the register entry obtained before it begins. Register entry data include the entity's address, its Central Register certificate and the list of devices it will sell with their classification. Retail of medical devices is carried on in pharmacies and/or in specialised shops, and a specialised shop must be entered in the Agency's register of specialised shops before starting the activity.

Medical devices are imported through a controlled border procedure: customs officers, together with pharmaceutical inspectors, exercise inspection at import, and the pharmaceutical inspector may prohibit import under the medicines inspection measures of Article 146, which Article 153(1) applies correspondingly to medical devices. A parallel imported device additionally requires a parallel import approval held by a registered wholesaler, and a health institution importing in parallel for its own needs may not place the device on the market.

Manufacturers, authorised representatives and importers must register through the electronic system (EUDAMED) and provide the Annex VI Part A Section 1 information before placing devices, other than custom made devices, on the market, obtaining a Single Registration Number; where the conformity assessment procedure requires a notified body, the information must be supplied before applying to it. Importers additionally bear the general obligations of Art. 13 (verify CE marking and EU declaration of conformity, ensure storage and transport conditions, register complaints).

Circular No. 15 of 2026 (19/02/2026) links medical device establishment approval with the clearance service; the Release of Medical Devices and Supplies service requires inclusion of all equipment and supplies in the department database, a commercial/purchase invoice, adherence to manufacturer transport/storage conditions, and an undertaking (service period: one working day, fee 5).

Local medical device establishments need MoH facility approval; store/warehouse requirements include temperature/humidity monitoring, municipal wholesale license, separate receiving/dispatch/storage and quarantine areas, no storage in apartments, MDCD approvals, and a digital inventory system recording batch numbers ensuring traceability from receipt to distribution; ownership must be Omani (owner/partner of Omani nationality, no partner in more than one pharmaceutical institution).

Selling medical devices and supplies requires the activity in the commercial registry, activated via a DSC service (1 2 working days, no fee) in adherence to MD 113/2020; per Circular 173/2025 all establishments importing medical devices had to comply with registering in the MoH portal before 01 09 2025.

Under rule 26(1), no medical device or component or raw material for manufacturing medical devices shall be released from customs unless a clearance certificate has been obtained by the importer from an officer authorized by DRAP.

Rule 24A (inserted by S.R.O. 559(I)/2022 dated 27.04.2022) permits import of medical devices for the purpose of donation, including devices otherwise prohibited from import without enlistment or registration, except products included in Schedule D and classes C and D, subject to the condition that the device shall not be sold or distributed in the market.

Under rule 5, an application for an establishment licence is made on Form 1 (manufacture) or Form 2 (import); the MDB may inspect the premises, constituting a panel of experts which may include inspectors or auditors, and if satisfied issues the licence on Form 3 (manufacture) or Form 4 (import).

DNDM verifies that premises meet infrastructure, equipment, hygiene and environment conditions for the regulated activities, recording an acta of the premises' fitness; it may inspect establishments ex officio or upon complaints, suspicions, vigilance reports, adverse events or device failures, with the power delegable to the Regiones de Salud.

Every device consignment entering or leaving Panama must carry (verified on the invoice and related documents): manufacturer name; importer/exporter name and address; invoice number; trade name; catalogue number; presentation; model and serial number for biomedical equipment; lot number and quantity; expiry date; a copy of the Panama Registro Sanitario (save statutory exceptions); and any other data required by the authority. Devices and biomedical equipment are exempt from all import tariffs.

Resolución DINAVISA N° 226/2025 regulates the procedures for opening, renewal of opening and modification of public and private establishments regulated by DINAVISA, approves process flows for pharmacies (Art. 9) and for production laboratories, quality control laboratories, fractioning and packaging plants and magistral preparation pharmacies (Art. 10), and keeps previously issued establishment authorisations valid until their own expiry date (Art. 11). Applications already in progress through DINAVISAPy when the resolution took effect continue under the rules in force at the time of their filing (Art. 12). It abrogates Resolución DNVS DG N° 001 of 13 January 2021 and Resolución DINAVISA N° 25 of 8 March 2022, and any provision contrary to it (Art. 14).

For a production, fractioning, packaging, importing, exporting or distributing establishment of medical devices, sharps and personal protective equipment to operate, it is mandatory to hold a valid certificate of compliance with Good Manufacturing and Control Practices (BPFyC) and/or Good Storage and Distribution Practices (BPAyD). The inspection procedure covers classes I, II, III and IV.

The BPFyC and BPAyD certification is valid for three years (36 months), computed as set out in Art. 5 of the resolution. To renew, the establishment must file the application and pay the corresponding fees to DINAVISA within the ninety (90) days before expiry (Art. 6). Where a certificate is renewed before the establishment has been inspected, the renewed certification may be revoked depending on the result of the later inspection (Art. 9).

Establishments must comply with applicable Buenas Prácticas (Manufactura, Laboratorio, Distribución, Almacenamiento, Dispensación, Seguimiento Farmacoterapéutico) and hold the corresponding certification; the ANM (DIGEMID) is the body that grants Buenas Prácticas certification to pharmaceutical establishments.

Establishments manufacturing, importing, exporting, storing, distributing, marketing, dispensing or selling devices require prior sanitary authorization to operate, granted after inspection; the sanitary authorization is a precondition for municipal operating licenses.

For controlled technology biomedical equipment emitting ionizing radiation, import requires a copy of the import authorization issued by the Instituto Peruano de Energía Nuclear (IPEN) or the competent authority.

During the B/C/D transition the device establishment's License to Operate had to be presented to the Bureau of Customs officer at the point of entry and/or as part of bidding requirements; with a valid CMDN, the issued CMDN and proof of payment for the CMDR application serve that role while the CMDR is processed.

Under DOH AO No. 2020 0017 (8 May 2020, Revised Guidelines on the Unified Licensing Requirements and Procedures of the FDA, repealing AO 2016 0003), establishments must secure a License to Operate from FDA before engaging in manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non consumer use, promotion, advertising or sponsorship of health products.

All licensed retailers are subject to routine or spot check inspection during operating hours by authorized FDA personnel; inspections verify business registration, qualified person credentials, SOPs reflecting good storage and distribution practices, valid LTO, copies of CMDN/CMDR of devices sold, and a risk management plan.

All retailers of medical devices may only sell or offer for sale devices with the appropriate FDA authorization (CMDR or CMDN) as applicable; prescription devices may only be sold against a valid prescription (ophthalmic devices dispensed by a registered optometrist).

LTO is required for establishments selling or offering for sale any medical device including IVDs: retail stores, clinics selling devices, online/social media/TV shopping sellers, medical device vending machine operators, optical shops, and drug outlets that also sell devices; grocery stores, supermarkets, convenience stores and kiosks are exempt from the LTO but remain liable if they sell unregistered/unnotified devices.

Distributors established in Poland who first make a device, system or procedure pack available on Polish territory must obtain access credentials to URPL's distributor register and, for each first imported device within 7 days, enter the Basic UDI DI (per EUDAMED), the manufacturer's name and address, and the device type and trade name per the label. Exemption: devices co packaged with a medicinal product that was assessed together with it. Online system d.urpl.gov.pl with a public list (d.urpl.gov.pl/wykaz/).

Importing into Poland devices that do not meet MDR/IVDR requirements (or systems and procedure packs containing them) for use in Poland is prohibited; import for strictly personal use is permitted.

Healthcare providers and other professional or business users who import a device, system or procedure pack into Poland for use there must obtain access to URPL's information system and enter the device data: for intra EU acquisitions the Basic UDI DI, manufacturer name and address and the type and trade name; for imports from outside the EU also the nomenclature code, model/reference/catalogue number, authorised representative and importer data, notified body number, the label and the IFU. URPL system: lg.urpl.gov.pl.

Poland prohibits, under MDR Art. 17(9)(b), making available or further use of single use devices that have been reprocessed; URPL can order withdrawal from the market or from use by administrative decision.

Distributors must comply with the good distribution practices of Portaria n.º 256/2016, de 28 de setembro (principles and norms of good distribution practice for medical devices); the same Portaria applies transitionally to wholesale distributors under DL 29/2024 art. 52(2)(c).

IVD wholesale distributors operating in the national market must communicate to INFARMED the IVDs they distribute, under the still in force Art. 12 of DL 189/2000 (name/address, list of products with brand/model, calibration documentation).

National manufacturers are exempt from the Art. 28 distribution notification for the devices they manufacture, provided they demonstrate compliance with MDR Article 31 (registration in EUDAMED).

Wholesale type distribution activities in Portugal — supply, possession, storage or delivery of devices for resale or use in medical services, health units, pharmacies and other retail outlets (excluding supply to the public) — depend on prior notification to INFARMED.

Distributors must possess and keep records of all device transactions for five years.

Distribution activity is only permitted if the operator has a responsible technical person (responsável técnico) ensuring compliance and adequate facilities/equipment for storage, conservation and distribution.

A license from MoPH is required for medical devices and equipment within a healthcare facility: a paper form submitted at MoPH (8:00 12:00), with attachments; no fee is charged; incomplete or handwritten applications are not accepted.

MoPH inspects pharmaceutical or medical shipments arriving in Qatar through all customs ports and takes the appropriate action; the request must include, among other documents, import permits and approvals for products requiring approval.

The fiscal invoice is issued within maximum 90 days of filing the permit application (art. 10(1) Ordin 566/2020); failure to pay the invoice within the stated term leads to closure of the file; after two free re evaluations, any new re evaluation is charged at 50% of the initial fee.

The entire permitting process for avize de funcționare is carried out online through the digital platform at https://avizaredm.anmdm.ro/login, where economic operators create user accounts.

Marketing and service activities in the medical device field are subject to ANMDMR operating permit control: (a) import of medical devices; (b) distribution of medical devices; (c) installation and/or maintenance of medical devices.

Activities in the sphere of circulation of medical devices — except clinical trials, production, installation, commissioning, use, operation including maintenance and repair — start under a notification regime; Roszdravnadzor accepts and records the notifications.

Production of medical devices and technical maintenance of medical equipment are licensed activities carried out by Roszdravnadzor; servicing performed for an organization's own needs is exempt.

Rwanda FDA guidelines reserve the importation of medical devices/IVDs to importers whose premises are licensed by the Authority or who fall within an eligible importer category, and the eligible categories are exhaustively listed in section 1.1.2: (a) licensed manufacturers and wholesale companies of pharmaceutical and medical devices/IVDs; (b) licensed retail of pharmaceutical and medical devices/IVDs, only on medical prescription, where the product is not available on the market; (c) public and private health facilities; (d) hatcheries; (e) the beneficiary of a donation; (f) non governmental organisations with a Memorandum of Understanding with the Ministry of Health or the Government of Rwanda; (g) government institutions and embassies; (h) UN organisations intervening in the health sector; (i) clinical trial sponsors and principal investigators; (j) a tourist, a visitor in the country, or any other person for justified reasons. Section 1.1.1 adds the transactional conditions: all devices to be imported must be registered or granted special approval by the Authority; every import application passes through two mandatory phases, Visa then Licence; importation of a pharmaceutical product labelled for sale in a specified country is prohibited in Rwanda except where Rwanda is one of the specified countries; all applications for import authorisation must be submitted using a platform defined by the Authority; all consignments must pass through the approved port of entry and are subject to physical inspection at the port of entry or at the importer's premises (where released under seal) before being used. The underlying prohibition is in the registration regulations: art. 34 of DFAR/HMDAR/TRG/002 Rev 2 provides that 'No person shall manufacture, prepare, store, export, sell, dispense, distribute or import Medical Devices or In Vitro Diagnostics Devices unless the person must hold the appropriate certificate of registration or notification issued by the Authority.'

An establishment may practice an activity subject to the Law only after registration and licensing by SFDA (establishment, branches and warehouses); manufacturers additionally need an industrial license from the competent authority. SFDA issues the establishment license valid for one year or similar renewable periods. Under the Implementing Regulation the AR license is renewable for up to a maximum of five years.

Imported devices may be cleared only with SFDA approval: an MDMA, or an import permit for devices exempted from MDMA. Devices containing chemicals, restricted gases or radioactive medical materials require both an MDMA and an import permit. Licensed importers/distributors must submit with each device: the Marketing Authorization Certificate, a manufacturer signed Declaration of Conformity, the UDI with machine readable code, labelling information, and manufacturer/AR contact details.

Establishments or companies whose object concerns medical devices are agreed by decision of the ARP's Director General to carry out wholesale and/or retail distribution of medical devices, after examination by a commission created for that purpose; the agreement specifies the class of devices and the authorised distribution activities for each type of establishment. Grant of an agreement for specialised wholesale and/or retail distribution establishments is subject to a prior inspection. Pharmaceutical wholesale import/export establishments, depositaries and distributing wholesalers are agreed by ARP decision to carry out wholesale distribution of medical devices, and pharmacies and in house pharmacies are authorised to sell at retail only the medical devices on a list fixed by decision of the ARP's Director General. Export of devices is reserved to manufacturing establishments and wholesale distribution establishments agreed by ARP decision, and concerns only devices holding a Senegalese marketing authorisation.

ALIMS may exceptionally authorise import of a medical device not registered in Serbia when intended for a particular patient or group of patients, as donation or humanitarian aid or an EU donation programme, for scientific research, or in an emergency. The device must undergo conformity assessment or an equivalent safety and performance assessment. The Minister prescribes conditions and manner (Bylaw on Import of Unregistered Medical Devices, 39/2018, 104/2018, 58/2021).

The Ministry of Health issues a manufacture licence for Class I devices (other than Is and Im), other IVD medical devices (class A), devices for which no conformity assessment is performed (not covered by a conformity mark), custom made devices, devices for clinical investigation, and systems/kits. The licence decision is issued within 60 days; an incomplete request must be supplemented within 15 days; the 60 day clock stops while additional information is requested. Manufacturers seated in Serbia for other classes instead undergo conformity assessment by a body.

Wholesale of medical devices (including import, export, procurement, storage, distribution) may be performed only by a legal or natural person meeting requirements for space, equipment and personnel, holding a licence for wholesale distribution of medical devices and operating under good distribution practice guidelines prescribed by the Minister (GDP bylaw 94/2018). Wholesalers must ensure continuous market supply and keep distribution records.

The registrant, manufacturers, importers and wholesalers (including exporters) must each establish documented procedures for distribution records and maintain a distribution record of each medical device, including low risk devices exempted from product registration.

A distribution record should be kept for the longer of the product owner's projected useful life of the device or two years after the device is shipped. For devices imported for export only, the retention period is two years after the device is shipped out of Singapore.

A dealer's licence is required to manufacture, import or wholesale medical devices in Singapore (HPA ss 12 14); unlicensed activity carries fines up to $50,000 and/or 2 years' imprisonment (up to $100,000/3 years for adulterated or counterfeit products). Licence holders must notify HSA of changes such as risk classification, QMS certification and site details.

Manufacturer's licence requires ability to comply with ISO 13485 (reg 2A); importer's and wholesaler's licences require ability to comply with the Good Distribution Practice Standard for Medical Devices or ISO 13485 (regs 2B, 4D); importers bringing in devices identical to registered ones without being the registrant need prior Authority approval per consignment.

Distributors making devices available in Slovakia (any person in the supply chain that is neither manufacturer nor importer; foreign entities included) can register with ŠÚKL under § 110a ods. 3 písm. a) of zákon č. 362/2011 Z. z. (regime effective 26 May 2021). Registration is currently voluntary — distribution without it is lawful — but becomes mandatory at national level from 28 May 2026 for distributors making devices available on the Slovak market regardless of seat. Registered distributors appear in the public alphabetical Zoznam distribútorov ZP/IVD ZP (updated daily).

A distributor seated in Slovenia must register in the JAZMP information system before starting activity on the Slovenian market; JAZMP registers the distributor within five days of a complete application; changes or cessation must be reported within 8 days; once a year the distributor must confirm data accuracy within a stated deadline of at least 30 days or face deletion from the register.

Until EUDAMED begins functioning, an importer seated in Slovenia must register with JAZMP before starting activity; at each first supply it submits the EU declaration of conformity and certificate, reports every purchase of devices to be placed on the Slovenian market, and keeps UDI records for supplied devices regardless of risk class; changes/cessation are notified within 8 days.

Manufacturers of custom made devices seated in Slovenia, health institutions reprocessing single use devices, and health institutions producing in house devices must register in the JAZMP information system before starting the activity; JAZMP registers them within five days of the application; changes/cessation within 8 days; annual data confirmation with a deadline of at least 30 days.

Laypersons may obtain devices only in primary level pharmacy units or shops defined by trade law; these must employ an 'oseba za strokovno svetovanje' advice person (at least secondary education, EQF level 5) present throughout opening hours; professional use devices reach laypersons only via health workers; remote sellers must offer remote professional advice.

An amendment to Regulation 6 of the General Regulations under Act 101/1965, published in Government Gazette No. 55152, Notice No. 7780, on 7 August 2026, expanded the ports of entry for import and export of health products and introduced requirements relating to import permits.

No medical device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA establishment licence; acknowledgement letters stopped being accepted as of 31 March 2020.

A person may not import a medical device or IVD into the Republic except through designated ports of entry: Cape Town International Airport or harbour, Port Elizabeth Airport or harbour, King Shaka International Airport or Durban harbour, or OR Tambo International Airport; used devices may be imported by a manufacturer only for service, repair, refurbishing or maintenance.

A person may only import a medical device or IVD if licensed under section 22C(1)(b) to import, and, in the case of unregistered devices, if authorised by the Council to import the unregistered device; devices transmitted through the Republic must be stored in a bonded warehouse registered with the Council and not be manipulated unless authorised.

Before applying for import approval/certification or filing import notification, the importer must already have the facilities and manufacturing/quality management system required for quality inspection under the Prime Ministerial Decree.

Spain defines nationally which devices are subject to prescription (custom made devices, serial products with written prescription, SNS funded products, individually adapted products, and products used or applied exclusively by healthcare professionals); distance (correspondence/online) sale to the public of prescription devices is prohibited, public sale of implantable and exclusive professional use devices is prohibited except by health establishments against prescription, and itinerant sale (venta ambulante) of devices is prohibited. A narrow exception allows successive contact lens deliveries by correspondence after initial adaptation.

Persons engaged in manufacture, import, grouping (agrupación) or sterilisation of medical devices require a prior operating licence (licencia previa de funcionamiento) granted by AEMPS; the equivalent IVD rule (manufacture, import, sterilisation, full manufacture for third parties) is in RD 942/2025 art. 7.1.

Foreign manufacturing sites require NMRA approval: a Site Master File must be submitted along with all applications for FMSA of medical devices, together with the FMSA application form, local agent business registration documents and manufacturer declarations. Listed medical devices are exempt from foreign manufacturing site registration.

The import licence should be renewed every year.

After MDEC decision and CEO approval, approved product registration applications are forwarded to the NMRA Licensing Division, which issues the Registration Certificate and the Import Licence to the applicant.

A Sample Import Licence is obtained through the NMRA Licensing Division using the approved Schedule IV Form C and evaluation sheet: the applicant submits the scanned approved form to the Licensing Division, pays the SIL fee, and must submit a copy of the SIL and a request letter to the accepting point to initiate evaluation.

Distributors and importers must inform Läkemedelsverket (primarily by e mail to registrator@lakemedelsverket.se) of suspected or confirmed serious risk with a product, suspected or confirmed falsification, and of intent to translate or repack under MDR Art. 16.2 16.4; importers must register in Eudamed.

Importers may only place compliant products on the market and must verify before doing so: presence of the conformity mark; availability of the declaration of conformity; that the manufacturer is known and has mandated a person per Art. 51; correct labelling and availability of instructions for use; and UDI assignment where required; they must state their own name and address on the product, packaging or accompanying document, and must withhold non conforming products until conformity is established. Distributors verify the same items (except importer details) with due care, on a sampling basis except for the importer information check, and must withhold non conforming products.

To operate as a medical device firm (manufacturer or distributor, including importers), the company must be approved and registered with the municipal or county/city government health authority and hold a business permit (許可執照) before commencing business.

Distributors of announced device categories must establish a good distribution practice (優良運銷) system per the GDP Regulations and pass central authority inspection to obtain a distribution permit (運銷許可) before wholesaling, importing or exporting; distributors must establish and maintain the GDP system in writing (Art. 3 GDP Regulations), covering storage, transport and temperature control for temperature sensitive devices.

Manufacturer premises must have smooth, crack free, easily cleaned ceilings, walls and floors; adequate lighting and ventilation with temperature/humidity/cleanliness controls where needed; protection, first aid and isolation facilities for flammable or hazardous materials; warehouses for raw materials, intermediates and finished products; and changing rooms and hand washing facilities with sterilisation equipment for work clothing as needed. Buildings must be structurally safe with rodent , insect and dust proof design; work areas must be clearly separated, with dedicated or effectively segregated areas when other products are co manufactured; environmental controls (and cleanrooms per ISO 14644 where air cleanliness matters) are required.

Device firms must employ at least one technical person per applicable category: manufacture of IVDs and of non IVDs for manufacturers; import and IVD/non IVD repair technicians for import or repair distributors. Manufacturing technicians need a relevant degree (medical engineering, medical laboratory science, or science/engineering/medicine/agriculture) plus 1 3 years of manufacturing experience; radioactive device technicians may alternatively hold medical radiology degrees with one year of experience. Import technicians need a degree, one year of manufacturing or registration filing experience, and at least 20 hours of training within the past five years covering device law, QMS, dossier preparation and filing practice, and post market management.

Manufacturing technicians are responsible for resident supervision of manufacturing, QMS documentation, adverse event management, safety monitoring matters and Act Art. 29 technical documentation; import technicians manage the same registration/monitoring duties plus source and flow documentation; repair technicians must verify repaired product safety and performance and sign repair records, which the repair distributor keeps for at least five years. Every technical person must complete eight hours of continuing education each year (law, quality management, violation case analysis); failure leads to ordered correction and ultimately a mandatory personnel re registration, with penalties under Act Art. 70(1)(1).

Distributors seeking a distribution permit (運銷許可) file an application (Chinese or English, with translations for other languages) with the central authority, attaching the business licence copy, documentation index, quality manual or equivalent, a floor plan of the premises marking storage, inbound/outbound and other work areas with flow lines, and a distribution process flow diagram including outsourced operations; a fee applies. Missing documents must be corrected within a set period or the application is rejected. After GDP inspection against the GDP Regulations, a permit is issued; a failed applicant may request re evaluation once within two months of the notice.

GDP records must be identified, stored, secured, retrievable and dispositioned under a written control procedure that also protects sensitive health information under the Personal Data Protection Act. Retention must be no shorter than the device's shelf life and in any case no less than three years from the manufacturer's release date; longer statutory periods prevail.

Medical device distributors (販賣業者) must establish the good distribution practice system (運銷系統) in writing and maintain its effectiveness: determine and execute the required processes, monitor their implementation, and record GDP activities. The regulation's storage, transport, service and staffing requirements are modelled on ISO 13485. Process changes require an impact assessment on the GDP system and the device before adoption.

The first three imports of the same item, brand and origin by an importer are inspected batch by batch. A batch failing reinforced sampling escalates that item back to batch by batch inspection; a batch failing normal sampling moves it to reinforced sampling (20 50%). Items return to normal 2 10% sampling after five consecutive compliant batches whose cumulative compliant quantity reaches three times the quantity of the failed batch.

Imported devices of the categories announced in the regulation's Annex 1 are subject to border inspection (查驗) before import release: document/label checks (查核) and laboratory testing (檢驗), applied batch by batch (逐批), by sampling (抽批 — 2 10% normal rate, 20 50% reinforced rate), or as on site checks at the storage location. The importer of record (報驗義務人) applies to the inspection body at the port of entry from 15 days before import, attaching the licence/registration/project approval copy, the import declaration and other specified documents, with a 20 day correction window. Sample quantities are free and limited to testing needs.

Devices that pass inspection receive an import permit. Devices that are hard to sample at the container yard, need testing longer than five days, or are perishable/unstable may be released early under a written undertaking (具結先行放行) and stored at a designated location; misusing that release suspends the importer's expedited release eligibility for one year. A failed inspection can be retested once within 15 days of the notice using the retained samples; after the retest window, remaining samples are destroyed, and failed devices must be re exported or destroyed by the importer of record.

No person other than a holder of a licence or permit under Cap. 219 may import or export into Mainland Tanzania any drugs, medical devices, herbal drugs or poisons.

Applications for medical device import/export permits must be submitted at least 6 weeks prior to shipment of the consignment.

TMDA processes medical device import/export permit applications within 7 days.

Importers and exporters must register their premises with TMDA before applying for import/export permits; the Act separately prohibits manufacture for sale, sale, supply or storage except in premises registered under section 18.

An importer must complete importer establishment registration (จดทะเบียนสถานประกอบการนำเข้า) before it can file medical device registration applications.

Import of medical devices must pass inspection by officials at medical device inspection checkpoints (ด่านตรวจสอบเครื่องมือแพทย์) once the checkpoint locations are announced under มาตรา ๖ (๑๗).

Importation of a medical device that customs has reclassified into chapter 30 of the customs tariff is subject to the State import monopoly and requires a prior derogation. ANMPS informed importers that, following revision of the status of hyaluronic acid based medical devices, the competent customs services reclassified them under tariff heading 30049000 of the customs nomenclature, corresponding to products falling under chapter 30 of the customs tariffs, so that their importation is now subject to the State monopoly; to unblock import procedures, a derogation from the State monopoly (document code 120) must first be granted by the Ministry of Health — Agence Nationale du Médicament et des Produits de Santé. The derogation is valid for twelve months from 25 August 2025.

Medical device sales centers (satış merkezi) must obtain an authorization certificate (yetki belgesi) from the provincial health directorate (müdürlük): documents are reviewed within 15 business days, an on site inspection is performed within 45 business days, and deficiencies must be cured within 45 business days of the inspection report; the application includes a commitment to sell only devices registered in the Kurum's registration and information system (Madde 5(2)(ç)) and registered centers must keep their recorded data up to date (Madde 8(4)).

Sales centers must immediately stop selling devices that the Kurum has announced as unsafe or non compliant within market surveillance and the warning system, return them to the manufacturer/importer, and share all related information and documents with the Kurum on request.

Держлікслужба and the customs authorities (органи доходів і зборів) jointly verify conformity marking at import: where marking is absent or defective the manufacturer/representative must bring devices into conformity, and if the violation is not remedied the authorities take measures to restrict or prohibit placing the device on the market and ensure its withdrawal.

A medical warehouse or medical store limited to medical equipment may entrust technical management to a medical equipment engineer or a specialist in a health profession who is licensed and dedicated to working in it, as an exception to the full time pharmacist requirement.

Import, export or re export of a medical product or raw materials used in its manufacture requires prior EDE approval or a permit, except for cases exempted by a Cabinet resolution under Article 31(2).

An import permit for medical materials and products is valid for two months from the date of issuance.

A registration under Reg. 7A must include a description of the device and payment of the relevant fee in accordance with regulation 53 of the Medical Devices Regulations 2002; changes to the registered information must be reported to the Secretary of State.

Registration is required of anyone who sells, leases, lends or gifts devices they made, refurbished or re labelled, systems or procedure packs, custom made devices, and IVDs including those for performance evaluation; if the manufacturer is based outside the UK it must appoint a single UK Responsible Person who assumes the registration responsibility.

Devices offered for import are reviewed by FDA at entry (entry data transmitted via CBP's ACE system); foreign manufacturers must meet FDA registration and listing, 510(k)/PMA, QMS, US agent, labeling, MDR, and inspection requirements; the initial importer (21 CFR 807.3(g)) must register and comply with 21 CFR parts 803 (MDR), 806 (corrections and removals), and 821 (tracking); a finished device not legally marketed in the US generally may not be imported (exceptions include import for export and personal importation of up to a 90 day supply).

Initial registration and listing must be submitted within 30 days after an establishment enters into an operation requiring registration; annual registration is required for all establishments for each fiscal year during the period beginning October 1 and ending December 31, even if no changes occurred; foreign establishments must register before exporting devices to the US and must wait for 510(k)/PMA clearance or approval before listing such devices.

Companies that produce, import, store, distribute or repair/maintain medical products must be habilitated by the MSP; the habilitación is valid for five years. The trámite (form FO 13222 003) is filed in person with a note to the Minister signed by the legal representative and the Dirección Técnica, notarial certificate, Director Técnico credential, premises documentation (plans, pest control, fire brigade clearance, staff health cards) and product lists; the certificate is valid up to 5 years from the date of the Ministerial Resolution and the trámite is fee bearing (arancelado).

Medical products offered at public auction must be previously inspected by competent MSP personnel to determine fitness and validity for use; only authorised firms may acquire them, and the auctioneer must report buyer details to the Departamento de Tecnología Médica within five business days.

Importing equipos y dispositivos médicos requires an MSP certificate obtained through VUCE trámite TECM: either a 'certificado negativo' (product not registered) or a 'desaduanamiento' (customs clearance) which requires the company to be registered with MSP and the product to have a registration application in process; VUCE transmits the approved certificate automatically to the Dirección Nacional de Aduanas enabling entry (certificate numbers start with prefix VU).

From 1 January 2026 the retail licence requirement for medical devices is abolished; retail proceeds by notifying the authorized body. Devices that must be certified may not be retailed without conformity certificates, and purchase, wholesale and retail of unregistered, substandard or counterfeit medicines and devices is prohibited.

Wholesale of medicines and medical devices may be carried out only by manufacturers and wholesale organizations holding a pharmaceutical activity licence, under Ministry of Health rules; manufacturers may wholesale only devices they produce unless they hold a wholesale licence.

IMDA issues medical device import licences under Art. 48 of Decree 98 (as amended); the application uses form Mẫu 10 of Circular 44/2025.

A Class C/D circulation number is the legal basis for verification registration, import, export and circulation of the device in Vietnam.

MOH does not issue import licences for used medical devices; import licences valid under the pre 2025 framework were extended only to 31/12/2024.

statement: ZAMRA controls importation and exportation through permits and licences separate from product marketing authorisation. The Act requires a marketing authorisation for any importation or supply of an allied substance (s.39(1)), and ZAMRA's published Fees for Permits schedule provides for import and export permits (333 fee units / ZMW 100), importation of medicines for personal use, importation of medicines in small quantities and importation of raw and packaging materials, together with wholesale pharmaceutical licences and health shop and agro veterinary shop permits. ZAMRA's Fees for Marketing Authorisation schedule ('Other fees') charges preclearance quality assurance fees on imports as a percentage of FOB invoice value: 1.5 per cent for registered commercial consignments, 5 per cent for unregistered medicines and allied substances, 1 per cent for donations and 1 per cent for active pharmaceutical ingredients, bulk finished products and intermediates.

statement: Importation of the two regulated device classes is controlled batch by batch rather than by an importer's licence. No importer, manufacturer or wholesaler may sell a condom or a glove unless the batch has been approved for distribution by the Authority, and the application for batch approval is made in duplicate on Form M.C.Con.2 or M.C.G.2. Condoms are subject to an import specific restriction: no person may import any condom which has less than six months of its shelf life remaining, and no person may sell any condom more than thirty six months old from its date of manufacture unless the manufacturer supplies satisfactory stability data for a longer shelf life. MCAZ describes the same process in operation as routine compliance checks of all condom and glove batches imported into the country.