Economic-operator roles by country

For classes II and III the local applicant is the manufacturer established in Albania, the foreign manufacturer's representative established in Albania, or a wholesale trader of devices holding the manufacturer's authorization; the wholesale trader performs import and export.

A 'representative of the device manufacturer' is any natural or legal person established in Albania, clearly designated in writing by the manufacturer, who acts in place of the manufacturer for its obligations within the territory of Albania.

All subjects placing class II and III devices on the market must appoint a person responsible for medical devices (person përgjegjës) holding a degree in law, biomedical/clinical engineering, electronic/chemical/physical/mechanical/electrical engineering, general medicine, dentistry, pharmacy or similar medical sciences.

The holder (détenteur) and/or operator (exploitant) of the homologation decision is responsible for placing the device on the market; only duly agréé pharmaceutical establishments can hold it.

The homologation or renewal dossier must be deposited with ANPP by the pharmacien directeur technique of the pharmaceutical manufacturing and/or exploitation establishment.

archetype: marketing authorization holder or registrant · name: ANMAT habilitated importer/manufacturer holding the product registration · required for foreign: yes · registration relation: holds or applies for registration · importer relation: often same · distributor relation: may be separate · combination: allowed subject to establishment authorization · note: All medical device importers without exception require ANMAT habilitación (Disposición 2319/02 t.o. 2004) and product registration; foreign manufacturers reach the market through the habilitated local company. Interprovincial IVD reagent distributors also require ANMAT habilitación.

Legal entities and individual entrepreneurs importing medical devices, or persons authorised by them (the applicant), submit to the authorised body an electronic application through the 'National Single Window for Foreign Trade' electronic system for the purpose of obtaining an import (conformity) certificate. The certificate is issued to the applicant, and the applicant is the addressee of deficiency notices, of the decision to grant or refuse, and of the certificate itself.

archetype: sponsor or local market entry owner · name: Australian sponsor · required for foreign: yes · registration relation: owns ARTG inclusion and market entry obligations · importer relation: may be same but each sponsor needs own ARTG entry · distributor relation: can be separate · combination: allowed · note: A health professional who supplies a device to the Australian market, including by using it in clinical practice, becomes the sponsor of the device.

path code: sponsor transfer by operation of law or new ARTG inclusion · fresh registration: no if transfer notified yes if no transfer · timing: Sponsorship changes by operation of law under regs 10AB, 10F and 10H of the Therapeutic Goods Regulations 1990 at the time of the triggering event (death, bankruptcy, winding up, business transfer), regardless of notification · notification: New sponsor must notify TGA as soon as possible after the event; current official guidance states no fee and no fixed statutory window · processing: TGA updates the ARTG entries usually within 10 working days of a complete signed notification · consent: The transfer form cannot be used without the current sponsor's consent; third parties such as manufacturers cannot lawfully transfer sponsorship · manufacturer evidence: Sponsor transfer does not transfer Manufacturer Evidence; the new sponsor must arrange appropriate manufacturer evidence

The sponsor must meet the definition of sponsor under the Therapeutic Goods Act 1989, which requires a recognised Australian based legal entity; sponsors are usually the Australian importer of overseas manufactured medical devices.

Operators who commercially place medical devices on the market may only entrust the informing and training of professional circles (Fachkreise) to Medizinprodukteberater possessing the required medical and medico technical expertise; advisors must undergo regular training, must prove their expertise to BASG on request, and must record reports from professional circles on side effects, interactions, malfunctions, technical defects, contraindications, falsifications and other risks in writing promptly and pass them to their client in writing.

The applicant ('ərizəçi') for device registration may be the inventor, the manufacturer, a wholesale pharmaceutical enterprise, or the Ministry of Health itself; and, for medical devices, also a legal person or individual entrepreneur that is neither a manufacturer of medicinal products nor a wholesale pharmaceutical enterprise. The applicant therefore does not have to be the manufacturer, so a locally established legal person or sole trader can file for a foreign manufacturer.

Manufacturers outside Bahrain cannot apply directly: only a facility registered with NHRA as a Medical Device Authorized Representative may apply, import and hold the registration. Resolution No. (48) of 2020 Article (1) defines an authorized representative as a natural or legal person established within the Kingdom holding a written mandate from the manufacturer, and Article (6) as amended by Resolution No. (69) of 2024 requires all facilities to obtain a licence from the Authority and prohibits any activity related to medical devices except through a licensed facility.

A foreign manufacturer that has concluded a licence agreement with a Bangladeshi drug manufacturing establishment may be permitted, subject to conditions imposed in the public interest, to manufacture drugs (including devices) within Bangladesh.

The registration application must be made by a local authorized person of the manufacturer, or the foreign supplier, or an authorized agent, to DGDA; an authorisation letter in original from the manufacturer authorising the local agent to be the applicant must be submitted.

The applicant for national registration (reregistration, dossier changes) is: the producer; a legal entity or individual entrepreneur within the same association (объединение) as the producer; or (for devices used in medicine production) a Belarusian pharmaceutical manufacturer that ordered foreign made devices not registered by their foreign producer. For limited quantity supplies, any Belarusian legal entity or entrepreneur involved in their circulation may apply.

'Authorized representative of the producer of medical products' = a legal entity, individual entrepreneur registered in Belarus, or a representative office of a foreign organization, empowered by the producer's power of attorney to represent it on circulation matters (incident reporting, recalls, receiving returned devices).

The producer (or its authorized representative) is responsible for the release of a medical product onto the market ('выпуск в обращение' = first transfer making the device available, excluding transfer for testing).

Importers and distributors that relabel or repackage devices (MDR/IVDR Art. 16(2)(a) and (b)) and intend to make them available on the Belgian market must inform the FAMHP and submit a certificate issued by a notified body within 28 days, via the 'my activities' section of the FAMHP web portal.

statement: Under Article 149 of DS 25235, every commercial package of a product, imported or national, must carry a sticker, seal, label or imprint identifying the company that markets the product, and the design or format of that marking must be included in the registration dossier. · article: Numeral 2.5.1(d)

statement: The Registro Sanitario certificate does not necessarily belong to the company that carried out the registration procedure; it belongs to whoever holds the licence or is the manufacturer of the product, and it may be used only by accredited legal representatives. · article: Numeral 3.2.1

statement: The application dossier must contain Form 027 in original plus two copies, completed by typewriter and signed and sealed by the company's legal representative and by the accredited regent or technical responsible — who may be a pharmacist, pharmaceutical chemist, physician, biomedical engineer, industrial engineer, electronic engineer, mechanical engineer or chemical engineer — as a declaration of the veracity of all documentation presented. · article: Numeral 2.1

Where a medical device is manufactured abroad, the duties that the Act places on the manufacturer are assumed in Bosnia and Herzegovina by the supplier or importer of the medical device. These duties include submitting to the Agency the documentation demonstrating that the quality assurance system and protection of public health are in place and that the device has been manufactured in accordance with the general and special requirements, submitting the documentation on design, quality control and maintenance, and reporting to the Agency any changes in the manufacturing process or in the specifications of the device.

A representative of a medical device manufacturer must hold the manufacturer's authorisation or a representation contract registered with the Ministry of Foreign Trade and Economic Relations of BiH. The manufacturer or the authorised representative must also submit complete information on the manufacturer's liability insurance for possible damage caused to the user of the device, valid on the territory of Bosnia and Herzegovina.

Under MRSA 2013 s.24(2) the registration application must be made by a company registered, licensed or operating in Botswana, so a foreign manufacturer cannot apply in its own name.

A foreign applicant must appoint a Local Technical Representative, also called an Authorized Representative, which must be a company resident or incorporated in Botswana; that representative is the applicant for BoMRA purposes and takes responsibility for compliance with Botswana law. The draft 2026 Regulations would put the same obligation on a statutory footing under section 36 of the 2025 Act.

Companies manufacturing, distributing or importing products under ANVISA's scope require ANVISA authorization to operate (Autorização de Funcionamento de Empresa AFE), under Lei 9.782/1999 Art. 7º VII, in addition to state/local sanitary licensing.

Alterations of an approval (including holder related changes processed under the alteration framework and IN 74/2020) take effect only after the final decision is published in the Diário Oficial da União.

The 'detentor (de notificação ou de registro)' must be a legal entity, public or private, manufacturer or importer, responsible for the device in the national territory, holding the marketing concession issued by ANVISA.

The only economic operator roles in Brunei health product law are those created by s. 15(1) of the Medicines Act: the holders of an import licence, a manufacturer's licence, a wholesaler's licence and a clinical trial import licence, each defined by reference to 'registered products', together with the product licence holder under s. 11(8). No Brunei instrument creates a local authorised representative, responsible person or registrant role for medical devices.

Chapter III of Regulation (EU) 2017/745 assigns the core obligations: manufacturers (Art. 10), authorised representatives (Art. 11, including the mandate and minimum list tasks of Art. 12), importers (Art. 13) and distributors (Art. 14); Art. 16 sets the cases in which those obligations shift to other operators.

The person responsible for placing medical devices on the Cambodian market must be licensed by Cambodia's regulatory authority before the devices are placed on the market, and each Member State must put in place an appropriate system for licensing that person.

path code: no AR manufacturer holds MDL importer distributor hold MDEL · notes: Canada has no authorized representative requirement: the MDL stays with the manufacturer (s.26) and each Canadian importer or distributor holds its own MDEL (s.44). A person outside Canada selling devices into Canada is itself considered a distributor and requires an MDEL (MDEL FAQ Q3). · fresh registration: not applicable for importer or distributor changes

'Manufacturer' means a person who sells a medical device under their own name (or under a trademark, trade name or label applied by them); the manufacturer is the MDL holder regardless of where the device is manufactured.

The registro sanitario may be requested by the legal manufacturer domiciled in Chile, or by an 'Authorized Representative or Titular': any natural or legal person established in Chile who has received and accepted a written mandate (power letter/letter of designation or signed contract) from a legal manufacturer located outside Chile to act on its behalf for its sanitary obligations before ISP; the registration is held under that representative's titularidad.

Before filing for device registration, the company must have completed: company enrollment (Inscripción de Empresa), warehouse authorization (Autorización de Bodega), and the request for the Customs Destination Certificate (Certificado de Destinación Aduanera, CDA) for devices with sanitary registration. A company enrollment prestación exists for manufacturers/exporters, importers and distributors together with the list of devices they market in Chile (catalog code 9100016).

The China agent designated by an overseas holder must carry out adverse event monitoring for the imported devices sold in China and cooperate with the overseas holder in re evaluation obligations; holder and agent must maintain an information transfer mechanism.

An overseas registrant exporting Class II/III devices to China must designate a Chinese legal person enterprise (我国境内企业法人, the China agent) that submits the registration application to NMPA on its behalf; the foreign manufacturer remains the registrant/holder.

archetype: marketing authorization holder or registrant · name: Titular of the registro sanitario / permiso de comercialización (natural or legal person) · required for foreign: yes imported devices must identify on the label/packaging/IFU the importer in Colombia or the manufacturer's authorized representative · registration relation: holds INVIMA registration · importer relation: importer identified on labeling; change of importer processed as a modification · distributor relation: can be separate · combination: allowed

path code: modification of registration (automatic under Art. 30 D. 582/2017; 'modificaciones de carácter legal') · fresh registration: usually no for valid registration · minimum handover: solicitud via Formato Único ASS RSA FM007 (pestaña Modificaciones Automáticas); authorization of the titular to the new importer; certificate of existence and legal representation of the new importer · notes: Holder/importer changes are modification events, not new registrations; significant changes require a new registro (Art. 30 parágrafo).

Post registration changes distinguish: change of holder (requires legal document signed by previous and new holder, new representative power, new labels, manufacturing contract, free sale certificate, radiation authorization if applicable, fee) and change of legal representative (requires only the new power of attorney). Both are tramited as post registration changes, not new registrations.

The holder or its legal representative may authorize third parties to import or distribute the product (distribuidores autorizados), either in the registration application or through a post registration change.

If the product holder does not reside in Costa Rica, it must appoint by power of attorney a legal representative (representante legal) domiciled in Costa Rica, who is legally answerable to the authority; the power must state validity and granted powers, conform to the issuing country's law, be in Spanish (or with official translation) and be legalized or apostilled.

The titular del producto is the natural or legal person owning an EMB marketed under a specific name or brand, legally answerable to the national regulatory authority; the holder is responsible for the device's safety and efficacy and must hold objective evidence available to the authority on request.

Two categories of person may apply for a device marketing authorisation in Côte d'Ivoire: manufacturers of medical devices; and Ivorian import and commercialisation companies that are agreed by the AIRP, mandated by the manufacturer, and applying for registration on the manufacturer's behalf. A foreign manufacturer with no Ivorian presence therefore cannot file directly — it must mandate an AIRP agreed Ivorian company. The application letter must state the name and registered office address of the manufacturer, of the applicant, and of the manufacturer's representative where there is one.

A manufacturer not established in a member state may place a device on the Union market — including the Croatian market — only if it designates a sole authorised representative established in the Union. The designation is valid only when accepted in writing and must be effective at least for all devices of the same generic device group; the authorised representative must be able to perform the mandated tasks, including verifying that the EU declaration of conformity and technical documentation have been drawn up and holding them at the disposal of competent authorities.

Manufacturers must have within their organisation at least one person responsible for regulatory compliance holding a relevant university degree plus one year of professional experience in regulatory affairs or QMS relating to medical devices, or four years of such experience. Micro and small enterprises may have the PRRC permanently and continuously at their disposal instead of within the organisation. The PRRC is responsible for checking device conformity under the QMS before release, keeping technical documentation and the EU declaration of conformity up to date, and ensuring post market surveillance, reporting and investigation obligations are met.

On an application for registration filed through the electronic system by a manufacturer, an authorised representative or an importer, HALMED verifies the data entered and, once it establishes their validity and compliance with the implementing act and with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, assigns the applicant a unique registration number. This is the Croatian registration step for economic operators; it is not a product approval.

For inscription, legal manufacturers are classified as OEM (original manufacturers), OBL (owners of the name/brand) or ODM (owners of the design). Evidence scales by type: an OEM presents only its own QMS evidence; an OBL presents its QMS plus the OEM's QMS and the contractual OEM OBL relations; an ODM presents its QMS plus that of the subcontracted production site. The inscription form (Anexo I) identifies the manufacturer type for each device in scope.

The 'suministrador' is a natural or legal person, established in Cuba or abroad, holding a written mandate from the manufacturer (or another suministrador) to act on its behalf in tasks related to the manufacturer's obligations under Cuban legislation. E 132 25 Nota 1 states this is the authorized representative for the regulation and need not reside in Cuba.

A manufacturer of a device that is not established in an EU Member State may place the device on the Cypriot market only if it designates a sole authorised representative in the Union. Cyprus applies this Union rule directly; CYMDA's importer notice treats the authorised representative as one of the economic operator roles that must be entered in EUDAMED.

CYMDA states that the general obligations of importers are set out in Article 13 and those of distributors in Article 14 of Regulations (EU) 2017/745 / 2017/746 respectively. In addition to those general obligations it lists: the duty of importers to register in EUDAMED (Article 31(1) MDR / Article 28(1) IVDR); the obligations of an importer that also acts as a manufacturer (Article 16 MDR and IVDR); product traceability (Article 25 MDR / Article 22 IVDR); and the obligations of economic operators involved with class III implantable devices (Article 27(8) MDR).

Cyprus applies the Union requirement that a manufacturer must have available within its organisation at least one person responsible for regulatory compliance (PRRC) who possesses the requisite expertise in the field of medical devices. The same chapter of the MDR extends the obligation to authorised representatives. Neither CYMDA's portal nor Decree No. 6 or Decree No. 7 adds a separate Cypriot registration, notification or qualification for the PRRC.

A distributor's ISZP notification must include, for devices other than class I / class A IVDs intended to be placed on the Czech market: the basic UDI DI of the device model in the UDI system (MDR/IVDR Annex VI Part C) and the intended purpose stated in the instructions for use. It must also identify the notifier (IČO, seat, data box), authorised representative, contact person and the activity notified (§ 23(2)(a) (d)).

A service person's ISZP notification must include the list of unique registration numbers of the manufacturers for whom servicing is intended, and a copy of the training certificate per § 45(4)(a) or § 46(2)(a) from each manufacturer (or its mandated person, with a copy of the mandate); these documents are not required where servicing is performed directly by the device's manufacturer.

Importers and distributors of devices or IVDs established in Denmark must notify the Danish Medicines Agency of name, address, CVR number, phone, e mail, role, and data identifying the device types imported/distributed; changes and cessation of marketing must be submitted. A 'distributør' is any person established in Denmark making devices available on the Danish market who is not simultaneously manufacturer or importer. Shops that only retail devices (detailforhandler) are not covered.

Reprocessing and further use of single use devices may only take place in accordance with MDR Article 17(2); the reprocessor assumes the obligations of a manufacturer under the MDR and the manufacturer obligations under lov om medicinsk udstyr and BEK 1731/2025.

Owners of a 'specialforretning' — a retail business specialised in dealing in class IIa, IIb or III devices or IVDs — must notify the Danish Medicines Agency of name, address, CVR, phone, e mail, functions and device types, and must report changes and cessation. 'Overvejende' (predominantly) means these devices make up more than 50% of the business's total product range and turnover. DKMA publishes a bruttoliste of these companies on its website.

statement: The foreign title holder must grant a power of representation to a pharmaceutical establishment established as representative in the Dominican Republic, duly notarised and certified before the Procuraduría for national applicants or legalised/apostilled for imported products; the applicant must supply a current copy of the sanitary registration certificate of the requesting/representing pharmaceutical establishment, laboratory or distributor. For imported products, Ley 42 01 requires the application to be endorsed by the pharmacist in charge of the distributor. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

Manufacturing and import establishments must have a responsable técnico who is a químico farmacéutico or bioquímico farmacéutico with a degree registered with SENESCYT/CESS; casas de representación (promotion, import and third party sale of their represented manufacturers' devices) and distribuidoras (import, export and sale) likewise require such technical responsibility and must comply with good storage/distribution/transport practices.

The titular del registro sanitario is the natural or legal person in whose name the sanitary registration certificate is issued and is legally and technically responsible for the quality and safety of the product in Ecuador, including the truthfulness of information given to ARCSA and compliance with manufacturing, storage, distribution, transport and sale rules. Foreign products need a local registration holder holding a valid operating permit (permiso de funcionamiento).

The registration applicant is an importing company, a local facility or a scientific office; the importing company is the first entity in the supply chain that imports devices into Egypt. For local devices without international certificates the applicant is the local manufacturer or its scientific office. A foreign manufacturer authorizes the applicant via a letter listing the devices it may register.

Egypt distinguishes the legal manufacturer (responsible for design, manufacture, packaging and labeling before placing on the market under its own name, and responsible for quality) from the actual manufacturer (where the device is in fact manufactured and packed on the legal manufacturer's behalf); both must be identified on certificates. F toll (contract) manufacturing is permitted under defined license holder conditions.

Where the manufacturer of a device is not established in an EU Member State, the device may be placed on the Union market — including the Estonian market — only if the manufacturer designates a sole authorised representative; the mandate is effective at least for all devices of the same generic device group.

For the duties of the manufacturer, its authorised representative, the importer and the distributor, the Medical Devices Act applies the requirements of the Product Conformity Act (toote nõuetele vastavuse seadus) with the modifications arising from the Medical Devices Act and from Regulations (EU) 2017/745 and 2017/746; the same reference covers notified bodies, conformity assessment and market surveillance.

Before a medical device can be registered for use in Ethiopia an overseas manufacturer must sign an agency agreement with a local agent established in Ethiopia who acts on its behalf for registration and/or import, distribution and sale. The application letter must be issued by the licence holder/marketing authorisation holder naming that local agent as the party authorised to submit. A licence holder or manufacturer may not authorise more than one registrant or local agent for the registration of the same product at the same time. The agreement must record the agent's position (first, second, third agent), assign responsibility for device vigilance and post marketing reporting to both parties, and require the manufacturer/licence holder and local representative to collect and submit device safety and performance evidence within one year of marketing in Ethiopia for all Class III and higher devices and Class C and higher IVD devices.

Where the manufacturer is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative; the mandate must be accepted in writing and covers at least all devices of the same generic device group. Minimum mandate tasks include verifying the EU declaration of conformity and technical documentation and keeping copies available to competent authorities for the Art. 10(8) period (Art. 11(3)).

Distributors making devices available on the market must act with due care in relation to applicable requirements; before making a device available they must verify CE marking and EU declaration of conformity, accompanying information per Art. 10(11), importer compliance with Art. 13(3) for imported devices, and UDI assignment where applicable (a representative sampling method is allowed) (Art. 14(1) (2) MDR).

Manufacturers must have available within their organisation at least one person responsible for regulatory compliance (PRRC) with requisite expertise in medical devices, demonstrated either by a diploma/degree in law, medicine, pharmacy, engineering or another relevant scientific discipline plus at least one year of professional experience in regulatory affairs or QMS relating to medical devices, or by four years of such professional experience (Art. 15(1) MDR).

Anyone professionally installing or servicing medical devices must follow the manufacturer's instructions on transport, storage, installation, maintenance, information security, updates and other handling, must verify the device is in the condition intended by the manufacturer before handover (servicing if needed), and must report dangerous situations suspected to result from a device defect or deficiency to the manufacturer, authorised representative, importer or distributor.

Fimea may issue regulations on national professional qualification requirements for the person responsible for regulatory compliance (PRRC) under MDR Art. 15(1) and (6) and IVDR Art. 15(1) and (6).

Three categories must declare their activities to ANSM: (1) any distributor making devices available on the French market (even incidentally), excluding resale to the public; (2) any manufacturer of custom made devices, or its authorised representative, placing them on the French market; (3) any natural or legal person sterilising devices in France for a manufacturer or for an assembler of systems/procedure packs, or sterilising CE marked devices designed to be sterilised before use.

For state registration the applicant is an 'interested person': a manufacturer, a trade licence holder, an importer or any other natural or legal person interested in the marketing authorisation who is willing to have the product registered under the recognition or the national regime — any person may act as interested person under the recognition regime. For the registration of a medical device clinical investigation the applicant may be the sponsor's authorised person: its official representation in Georgia or a clinical research organisation (CRO) registered in Georgia; a sponsor investigator may apply only if it itself finances and carries out the manufacture of medical devices.

Under § 81 MPDG, importers (implementing MDR/IVDR Art. 13(2) subpara 2 / (7) information duties) and distributors (Art. 14(2) subpara 2 and (4)) must notify: (1) assumption of a serious risk posed by a product to the competent federal higher authority via the German medical device database (DMIDS, § 86 MPDG); (2) assumption that a product is falsified to the authority competent for the trader's or importer's seat.

An application for registration of a medical device can be made by a manufacturer or by an importer of the device; the applicant is responsible for the product and all issues relating to it.

The local agent must monitor the device on the market and inform the Authority of any relevant issue including serious manufacturing defects, facilitate communication between applicant and Authority, handle device recalls, and provide technical support and services to users.

A non resident applicant must appoint a local agent: a corporate body registered in Ghana mandated by the applicant, evidenced by a power of attorney or equivalent documentation.

A company distributing medical devices in Greece must include 'Εμπορία Ι/Π' (trade in medical devices) in its corporate charter purpose and hold a medical device distribution certificate (βεβαίωση διακίνησης Ι/Π) issued by a notified body in accordance with Ministerial Decision ΔΥ8δ/Γ.Π.οικ.1348/2004 (ΦΕΚ Β' 32/16 01 2004) on principles and guidelines of good distribution practice for medical devices.

A device may be imported only when it is registered or inscribed before the DRCPFA, and only establishments holding a current sanitary licence as importer may carry out the importation. Unlicensed operators cannot place devices on the Guatemalan market.

The device inscription application must be signed, sealed and stamped by a professional Químico Farmacéutico, and the dossier must include an authenticated copy of the manufacturer's power of representation. For IVDs the signature may be given by a Químico Farmacéutico or Químico Biólogo. A Guatemalan licensed professional and an appointed representative are therefore necessary parties to the filing.

The establishment that registers the device must hold a sanitary licence issued under AG 712 99; a simple photocopy of that licence is a required element of the inscription dossier. The national trámites record adds that the principal distributor or droguería and any additional distributors or droguerías must also hold a current sanitary licence.

Transfer of LRP of a listed medical device is regarded as a Major Change; the party taking over submits a Takeover Application in MDIS (New, Change, Renew, Delist and Takeover application types all run through MDIS).

The listing applicant must be a local manufacturer or a Local Responsible Person (LRP) designated by the manufacturer; the LRP must be a legal person incorporated in Hong Kong, or a natural or legal person with business registration in Hong Kong.

Application for inclusion on the List of LRPs must be made together with the device listing application; required documents include a valid Business Registration Certificate, the manufacturer's designation letter and a set of documented procedures.

An operator that brings the device into the EU market from outside the EU in the course of commercial activity also qualifies as an importer and has a registration duty in the EU device database (EUDAMED).

The Icelandic authorised representative duty is an EEA wide duty. The Act's definition of 'viðurkenndur fulltrúi' is a natural or legal person established in the European Economic Area who has received a written mandate from a manufacturer established outside the EEA to act on the manufacturer's behalf for specified tasks in relation to the manufacturer's obligations under the Regulations. A mandate given to a representative established in another EEA State therefore satisfies the Icelandic requirement, and Iceland does not require an Iceland established representative of its own.

Act No. 132/2020 defines the operator roles for Iceland. Where the manufacturer of a device is not established within the European Economic Area, the device may only be placed on the EEA market if the manufacturer appoints an authorised representative; the appointment and duties of the authorised representative follow Articles 11 and 12 of the Regulations. The manufacturer must also have at least one person responsible for regulatory compliance with the required knowledge under Article 15 of the Regulations (Art. 23 of the Act).

A foreign manufacturer must appoint an Indian authorised agent a person, firm or organisation appointed through a power of attorney to undertake import of the device in India; the agent holds the import licence and must itself hold a manufacture/wholesale licence or an MD 42 sale registration.

Changing the name or address of the overseas manufacturer or the authorised agent is a major change under the Sixth Schedule requiring prior CLA approval before taking effect; a change in constitution of the licensee requires a fresh application within 180 days, with the existing licence deemed valid until decision.

Termination of the producer's appointment of the distributor/importer is an explicit ground for revocation of the device izin edar (PMK 5/2026 Pasal 51(1)(d)), and the izin edar lapses when the appointment as sole/exclusive agent or power of attorney expires or is not extended (PMK 62/2017 Pasal 25(d)). A new appointed importer must therefore register the product anew (one importer per brand, Pasal 13).

Import izin edar applications are filed by: (a) the Sole Agent/Sole Distributor/Exclusive Distributor; (b) a licensed importer (PAK) appointed and empowered by the manufacturer/principal; (c) a PAK owning the product with a cooperation agreement with the manufacturer; (d) a PAK performing assembly; or (e) a PAK performing repackaging. Domestic applications are filed by the producer, toll manufacturer, assembler, product owner PAK with cooperation agreement, or OEM producer.

Each type of imported device/PKRT with one trade name/brand from one manufacturer or principal may be agency held by only one PAK (licensed importer) or PKRT importer.

Foreign manufacturers act through an Iranian company: the directorate's official process 'راهنمای تشکیل شناسنامه و ثبت نمایندگی کمپانی‌های خارجی' (guide to forming the company profile and registering the representation of foreign companies) governs registration of the foreign manufacturer's representation; import authorizations are held by the licensed Iranian importer.

Manufacturers must have a مسئول فنی (technical officer) whose competence is approved by the Medical Equipment Commission (Article 6 of the medical equipment regulation); the technical officer supervises quality system execution across production, ordering, quality control, storage, hygiene and safety, training and records; legal responsibility for production under the license rests on the CEO and the technical officer.

For pharmaceutical company and manufacturing site registration with MOH, the manufacturer's authorization must be issued in the name of the scientific office or the authorized person inside Iraq; foreign pharmaceutical manufacturers therefore act through a scientific office or authorized person established in Iraq.

An authorised representative established in Ireland must, when registering with HPRA, furnish sufficient evidence that it has been designated by the manufacturer for the device concerned (in addition to organisation and device details).

Applications are filed by the Israeli registration holder/importer: the dossier includes current importer and manufacturer declarations (importer/manufacturer declaration no older than 1 month; foreign manufacturer declaration no older than 3 months; personal wet signatures + company stamp + signer's role) and the local business licence number and expiry per regulation 1.3 issued by the local authority.

On change of the registration holder/importer, the new registration holder's declaration replaces the old importer declaration; in the fast track a lawyer signed affidavit of the appropriate wording must be filed.

Manufacturers, authorised representatives (mandatari) and importers must register, under their own responsibility, in the EUDAMED economic operator electronic system before placing on the market a device other than a custom made device. The duty also extends to placers of procedural systems/kits (MDR Art. 22(1),(3)) and to manufacturers of class III implantable custom made devices and custom made devices subject to reporting under MDR Arts. 87 88 (Art. 12(2)).

Only holders of the class matched MHLW marketing license may market devices/IVDs as MAH: 高度管理医療機器 → 第一種医療機器製造販売業許可; 管理医療機器 → 第二種; 一般医療機器 → 第三種; IVDs → 体外診断用医薬品製造販売業許可.

A foreign manufacturer of certified designated products must notify the certifying registered certification body within 30 days of changing its appointed Japan MAH (or changes to the MAH's details) (Art. 23 3(2)); MAH side events such as business suspension/closure or changes to the 総括製造販売責任者 are notified to MHLW within 30 days (Art. 23 2 16(1)).

Foreign manufacturers of devices/IVDs exported to Japan register each manufacturing site with MHLW (医療機器等外国製造業者登録); product approval is refused if the manufacturing site lacks domestic registration (Art. 23 2 3) or foreign registration (Art. 23 2 4) (Art. 23 2 5(2)(ii)).

The authorized person (الشخص المفوض), who represents the importer, manufacturer or distributor agent and is accredited with the Medical Devices and Supplies Directorate, must be specialized in the work, hold at minimum a diploma, and be an employee of the entity whose transactions he follows up.

Only the responsible pharmacist (الصيدلي المسؤول) or the authorized person (الشخص المفوض) may follow up and complete transactions with JFDA under the Testing Regulation.

Manufacturers from third (non EAEU) states must appoint an authorized representative of the manufacturer acting during circulation of the device; the applicant for registration is the manufacturer or its authorized representative.

PPB registers all Local Authorized Representatives (LAR) for medical devices in Kenya; only one LAR may be identified and this must be consistent across device labels and Declarations of Conformity; the requirement is mandatory before registration approvals are granted. LAR duties include acting as primary contact point with the authority, keeping the technical file available, adverse event and incident notification (with a declaration to provide regular vigilance reports to PPB), supply chain compliance, product safety vigilance reporting, FSCA implementation/management/coordination and reporting, and annual technical file review. Any manufacturer based outside Kenya must designate an LAR with written evidence (Letter of Authorization, Annex 1 template).

Under rule 4(2)(b) of the 2022 Registration Rules, an applicant who is not resident in Kenya (foreign manufacturer) must appoint a local representative who is a citizen of Kenya, a person with permanent residence, or a company incorporated in Kenya.

statement: A manufacturer of a device that is not established in a Member State may place the device on the Union market only if it designates a sole authorised representative. Where that authorised representative has registered a place of business in Latvia, it must give the State Agency of Medicines, before the device is placed on the market, its own name, registration number, legal address and unified registration number, the address of the registered place of business, the manufacturer's identity, the manufacturer's written mandate under Article 11(3) of Regulation (EU) 2017/745, and the UDI DI of the manufacturer's class I devices and procedure packs intended for the EU/EEA market and must notify changes immediately. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: Yes · targetDecisionRetained: No

statement: Under Regulation (EU) 2017/745, where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. This applies equally to an FDA , PMDA , MFDS or NMPA approved manufacturer: designating a representative does not replace CE marking. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: Yes · targetDecisionRetained: No

Companies wishing to import medical devices must have a local agent or a distributor, and that local agent or distributor must register the devices commercialised with the Ministry of Public Health. The application for registration is addressed by the manufacturer, importer or distributor to the MOPH health technology unit.

Manufacturers with a seat in Lebanon, commercial representatives, importers and distributors must declare themselves to the Ministry of Public Health, communicate the information required for registering the products they commercialise, and hold an authorisation from the manufacturer for each product introduced and commercialised on the local market. Supplier declaration is a precondition of a first import operation, and the MOPH assigns each declared supplier a username and password for the online device registration system. The MOPH authorisation given to the supplier is granted for one renewable year.

Manufacturers established in Liechtenstein do not need to appoint a Swiss authorised representative for the customs union channel (Art. 51 MepV / Art. 44 IvDV); authorised representatives seated in Liechtenstein, and manufacturers whose representative is seated in Liechtenstein, submit documentation on request directly to the Amt für Gesundheit.

Where a device manufacturer has no establishment in an EEA member state, the data required by HSL Art. 59 1(3) must be submitted by the manufacturer's authorised representative established in the Republic of Lithuania.

Any manufacturer established in Luxembourg placing devices on the market in its own name must register with the Direction de la santé (meddevices@ms.etat.lu); EU authorised representatives established in Luxembourg must likewise register. Luxembourg recognises EUDAMED registration as fulfilling these national requirements. Importers and system/procedure pack suppliers established in Luxembourg register via the EUDAMED Actor Registration Module; every registration request must be validated by the competent authority.

Two applicant categories exist: (a) natural persons domiciled in Macau or legal persons incorporated in Macau that manufacture devices in or outside Macau, directly or through contract manufacturing; (b) importers seeking to place abroad registered devices on the Macau market, which must hold a Macau import/wholesale licence (medical device operator licence, drug product importer/wholesaler licence, or Chinese medicine import permit). Applicants must have no debts under enforced tax collection.

Establishment (establismen) means (a) a manufacturer, importer or distributor responsible for placing a medical device on the market (retailer excluded), and (b) an authorised representative appointed by a manufacturer with its principal place of business outside Malaysia.

A manufacturer not located in Malaysia must appoint an authorised representative (AR) to act on its behalf; for imported devices the AR obtains all conformity evidence from the foreign manufacturer and is responsible for appointing an MDA registered CAB to conduct the conformity assessment.

A manufacturer not established in a Member State may place a device on the Union market — and therefore on the Maltese market — only if it designates a sole authorised representative. The authorised representative must be established within the Union, accepts a written mandate that is effective at least for all devices of the same generic device group, and can be required to supply the mandate to the competent authority. Malta prices this role separately: an authorised representative established in Malta pays an initial organisation registration of EUR 500 and an annual organisation registration of EUR 1,000.

S.L. 458.59 recognises four economic operator roles — manufacturer, authorised representative, importer and distributor — and requires every operator that imports, wholesales, manufactures or re purposes a device in Malta to have a medical device registered person in Malta. No one may act as a medical device registered person for a device locally without registering with the competent authority; registration yields a registration document. The Authority's guidance describes the MDRP as a person appointed by an economic operator, registered with the Malta Medicines Authority, responsible for ensuring regulatory compliance of devices placed on the Maltese market, and requires at least one such person in the organisation.

archetype: marketing authorization holder or registrant · name: Titular del registro sanitario (Mexican registration holder) · required for foreign: yes · registration relation: To hold a device registration the applicant must operate a notified establishment in Mexico (fábrica/laboratorio de producción, almacén de depósito o distribución, o acondicionamiento) with aviso de funcionamiento; foreign manufacturers act through a representation letter holder. · importer relation: may be holder or named importer · distributor relation: may be holder or use registration with authorization · combination: allowed

Assignment of rights over a registration must be communicated in writing to the Secretaría by the new holder within no more than 30 working days of the assignment, attaching the assignment documents and duplicate Spanish label projects showing the new holder; an inscription fee applies under LFD Art. 195 K.

The applicant is the manufacturer seated in the Republic of Moldova or, for manufacturers seated outside Moldova, the manufacturer's authorised representative designated by a written agreement concluded in compliance with the minimum requirements annexed to the Procedure. An authorised representative is a legal person seated in the Republic of Moldova designated in writing by the manufacturer, by an agreement meeting those minimum requirements, to act on the manufacturer's behalf in relation to AMDM within the limits of the mandate granted. A delegated responsible person is the natural person designated by the authorised representative to file applications and communicate with AMDM through the personal cabinet. Where a manufacturer seats outside Moldova it designates an authorised representative in Moldova.

An application for registration, renewal, amendment or de listing is lodged with the Agency by the manufacturer, the supplying organisation (ханган нийлүүлэх байгууллага) or the manufacturer's official representative. Where a supplying organisation is to exercise the functions provided in Art. 40.8 of the Law in Mongolia, the listing dossier must include an original letter of the manufacturer designating that supplying organisation.

statement: The registration application must be filed by a manufacturer seated or residing in Montenegro or its authorised representative, and for a manufacturer without seat, stay or residence in Montenegro by that manufacturer's authorised representative. The applicant must employ a person responsible for documentation and a person responsible for vigilance, and must be permanently available. The documentation responsible person must hold a health, technical or law degree; the vigilance responsible person must hold a health or technical degree depending on the type of device, plus additional education in vigilance. The applicant is responsible for the credibility of the documentation in the registration procedure. · localAgentRequired: Yes · localAgentRole: ovlašćeni predstavnik (authorised representative) established in Montenegro

In Moroccan law a 'certificat de libre vente' for medical devices is a document the administration issues TO an export establishment, attesting that the devices concerned conform to the good manufacturing rules of loi 84 12. It is granted to an establishment that exports new, refurbished or used devices, and the arrêté adds it to the dossier of a locally manufactured device only where that device will also be exported. A foreign manufacturer seeking Moroccan registration does not obtain or file a Moroccan certificat de libre vente; the inbound document it files is the origin country certificate under dossier item 4.

The registration certificate is granted only to a manufacturing or importing establishment that has been declared to the administration in Morocco. A foreign manufacturer cannot hold the Moroccan registration directly; the registration holder is the Moroccan establishment, and only that establishment's legal representative signs and stamps the dossier. The dossier must also contain an attestation from the manufacturing establishment or its agent evidencing the link between the manufacturer and the applicant establishment.

The applicant is a local company (copy of business licence or certificate of incorporation required) acting with a letter of authorization from the product owner or manufacturer.

The Dutch notification duty falls on a manufacturer established in the Netherlands or on an authorised representative established in the Netherlands representing a non EU manufacturer; importers and distributors have no national registration role.

'Sponsor' means a person in New Zealand who exports or arranges export of the device from New Zealand, imports or arranges import of the device into New Zealand, or manufactures or arranges manufacture of the device in New Zealand for supply; it excludes a person acting on behalf of another person who is resident in, or carrying on business in, New Zealand. The sponsor holds the WAND duties under regs 5 10.

The sponsor must be recorded in the database with the address of its registered office or principal place of business in New Zealand, plus a contact telephone number or email address for both sponsor and (overseas or local) manufacturer.

Registration documents must include evidence of business incorporation by the Nigerian Corporate Affairs Commission (CAC), so the applicant/local agent is a Nigerian incorporated company; brand name must additionally be registered with the Trademark Registry (Ministry of Industry, Trade and Investment).

An applicant filing on behalf of an overseas manufacturer must file a Power of Attorney issued by the manufacturer, signed by a senior officer, stating brand name ownership, notarized by a Notary Public in the country of manufacture, and valid for at least five years.

For device post market surveillance: the manufacturer monitors performance, reports events and initiates FSCA; the MAH liaises with NAFDAC and submits reports; importers/distributors communicate Field Safety Notices and maintain distribution records; healthcare providers detect and report incidents.

The device registration form requires the applicant to state the capacity in which it applies — manufacturer (Производител), authorised representative (Застапник) or representative (Претставник) — together with the manufacturer's name and address and the name of the authorised representative in the European Union. A manufacturer seated outside the European Union must name an authorised representative in the EU and supply an EN ISO 13485 certificate; a manufacturer seated inside the European Union supplies the EN ISO 13485 certificate without the EU representative entry.

Where a medical device is manufactured abroad, the duties the Law places on the manufacturer are assumed by the importer of the device into North Macedonia. This makes the domestic importer the legally responsible economic operator for a foreign product, alongside the register entry of the manufacturer and of the authorised representative recorded in the registration dossier.

Registration to perform wholesale of medical devices is granted to a legal entity that has notified its activity to the Agency, employs an adequate number of staff with higher education in medicine, pharmacy or dentistry, operates a quality system protecting public health, employs a person responsible for monitoring and reporting adverse effects and reactions of medical devices, and trades only in devices that comply with the general and particular conditions and are properly marked. The detailed premises, equipment and staff conditions and the entry documentation are prescribed by the Director of the Agency. The application is decided within 90 days, and the entry records the entity's address, its Central Register certificate and the list of devices it will sell with their classification.

A manufacturer without a business address in the EEA that markets devices in its own name in the EEA must, before marketing, appoint an authorised representative established in the EEA; an authorised representative with a Norwegian business address must register its company and device data in the public device register like a Norwegian manufacturer.

Manufacturers, authorised representatives, importers and system/procedure pack assemblers must register in the EUDAMED actor registration module and receive a Single Registration Number (SRN); distributors are not required to register in EUDAMED.

Device registration requires a local agency: a copy of the commercial agency certificate and a local agency certificate; for foreign manufacturers the manufacturer registration requires a local agency certificate.

All medical device manufacturers (local and foreign) must be registered with DSC before their products can be registered; registration of a foreign manufacturer is applied for through the local agent and requires a copy of the Medical Devices Manufacturer License.

The local economic operator role for foreign devices is the importer acting as authorized representative in Pakistan who must hold a valid establishment licence; this party submits the enlistment or registration application under rule 14(1)(b).

Under rule 17(1) the enlistment or registration certificate holder must apply to the MDB for prior approval of any change to the particulars provided for the enlistment or registration, or any proposed change that may affect the safety or performance of the device; the change application is made on Form 6/6A or Form 7/7A with the rule 63 fee (rule 17(2)).

Ley 90 defines the Fabricante (designs, manufactures, conditions and labels the finished product) and the Importador (brings the product into Panama for commercialization, donation, demonstration or warranty). Any public institution, private establishment or natural person engaged in manufacture, conditioning, import, export, distribution, marketing or storage of devices must hold a Licencia de Operación issued by DNDM; that licence covers devices only, not pharmacological products.

An imported device application requires a power of representation or a distribution and commercialisation authorisation letter from the manufacturer, registered in the Registro Público de Poderes, naming the importing company and expressly authorising it to represent, distribute and commercialise the products in Paraguay. Where two or more companies claim to represent the same manufacturer, the exclusive representative letter wins, and failing that the letter issued directly by the manufacturer beats one issued by a distributor. Withdrawal of the representation must be notified to DINAVISA immediately.

The applicant's responsible technician declares the device class in DINAVISAPy with a technical justification, and the label must carry the name of the legally qualified responsible technician. DINAVISA may verify the truth of the documentation at any time; the applicant and the responsible technician are responsible for the integrity and authenticity of the information, documents and declarations filed.

Companies holding sanitary registrations are the final parties responsible for the quality, safety and efficacy of their medical devices and must implement and maintain a documented system for collecting and managing reports of adverse events and incidents and safety information generated by their products, including communicating alerts and measures taken abroad.

Device establishments (manufacture, import, export, storage, distribution, marketing, dispensing, sale) must have a director técnico who is a químico farmacéutico (or other professional where the Reglamento so provides); quality responsibility is shared solidarily between the director técnico and the establishment's legal representative, and the registration holder bears responsibility for device quality.

The applicant for CMDN/CMDL/CMDR is a manufacturer, trader, or distributor importer exporter; a License to Operate (LTO) is the FDA authorization for a person or establishment to operate in those capacities. Local applicants therefore act through an LTO licensed establishment.

Legal Manufacturer means any foreign medical device establishment responsible for design, manufacture, packaging and labeling of a device placed on the market under its own name; Product Owner supplies the device under its own name and is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying it.

The Market Authorization Holder (MAH) with a valid CMDN for Class B/C/D devices must apply for CMDR at any time within the CMDN validity period; while the CMDR is being processed the MAH may continue to manufacture, import, export, distribute and/or sell the product, presenting the CMDN and proof of payment at the point of entry or in bidding.

A producer of custom made devices, the authorised representative of a foreign custom device producer, and a custom device importer, each established in Poland, must apply to the President of URPL to register their activity before placing the device on the market; the register is public (BIP). URPL operates an online register at wnz.urpl.gov.pl with a public list of producers and devices.

Importer and distributor obligations apply to a foreign entrepreneur conducting business in Poland through a branch within the meaning of the 2018 Act on participation of foreign entrepreneurs in economic turnover.

The exercise in Portugal of the activities referred to in MDR Article 16(2)(a) and (b) (activities that make the importer or distributor subject to manufacturer obligations) requires a communication to INFARMED; the communication terms are set by deliberation of the INFARMED board, and the applicant is responsible for the truthfulness and updating of the information submitted.

The IMD registration applicant is a healthcare facility: the form captures Facility Name and License No., and the checklist requires the registration certificate of the applicant facility.

IMD registration requires an authorization letter or contract from the manufacturer for the local agent, with clear details of service validity and responsibilities.

Distributors or importators performing relabelling or repacking under MDR art. 16(2)(a) (b) must inform ANMDMR when making the device available, attaching the Romanian translated label/IFU; ANMDMR registers the economic operator in the national database with its translation/repacking activity and issues a confirmation letter (annex 8, form per annex 7, Ordin 3539/2022).

Foreign manufacturers must appoint an authorized representative of the manufacturer (уполномоченный представитель производителя/изготовителя) who bears responsibility for the device's circulation in Russia, including conformity assessment and state registration procedures; a copy of the document(s) confirming the representative's powers is a mandatory dossier item for foreign manufacturers.

Under the 2025 rules, authorized representative information in registration dossiers had to be actualized by 01.09.2025; the deadline was extended to 01.09.2026 by Government Decree No. 1206 of 13.08.2025.

An application for registration or notification of a medical device or IVD is made to the Authority in writing by the applicant, the manufacturer or a Local Technical Representative. A Local Technical Representative (LTR) is any corporate body registered in Rwanda and authorised by Rwanda FDA to deal with medical devices and IVDs that has received a mandate from the applicant to act on its behalf in matters pertaining to registration. The submission must include a letter of authorization from the manufacturer authorising the LTR to submit the application, clearly highlighting the LTR's responsibility. The LTR is published against the registration in the register and on the Authority's website listing of registered devices.

The AR must represent the manufacturer before SFDA, cooperate in post market surveillance, inform SFDA of incidents occurring outside the Kingdom that affect devices circulated in KSA (with circumstances and corrective actions), and inform SFDA of all corrective actions from manufacturer investigations. MDS REQ9 adds: notify NCMDR of delays/unavailability of devices posing high potential risk to medical services, and ensure after sales service including approved spare parts through the device lifecycle.

Foreign manufacturers must appoint an Authorized Representative (AR): located in the Kingdom, holding a separate SFDA AR license for each manufacturer represented, implementing a QMS per Art. 22.1, and documenting operations for SFDA inspection. Only one AR may be appointed per class or general group of devices; a different AR is allowed per category/group.

On termination or non renewal of the AR agreement, the manufacturer must immediately appoint a new AR, transfer all previous obligations to them, and notify SFDA of the change. The outgoing AR's responsibility does not end on its own request to terminate unless a replacement is appointed or the devices are no longer on the market or in active use.

The applicant for a device marketing authorisation files with the ARP through its local representative. The UEMOA harmonised framework, which Senegal transposes, requires a manufacturer wishing to place devices on the market in its own name without a registered office in the UEMOA area to designate a local representative established in the UEMOA area, and provides that the manufacturer remains the sole principal and remains responsible for its product even when it contracts with a representative or subcontractor. Separately, any producer or holder of a marketing authorisation for a medicine or other health product in Senegal, or its representative, must permanently retain the services of a qualified person resident in Senegal responsible for vigilance matters and with proven vigilance experience, and must establish and maintain a vigilance system.

A change of authorised representative is defined by a contract concluded as a rule between the manufacturer, the outgoing and the incoming AR, containing at least: termination date of the outgoing and start date of the incoming AR; the date until which the outgoing AR may appear in manufacturer data and promotional material; transfer of documents including confidentiality and property rights; and the outgoing AR's duty to hand over complaints, quality and incident defects after mandate expiry. The manufacturer or the new AR must file the amendment request with ALIMS without delay; the request includes the AR change contract with a certified translation.

The registration application is submitted by: (1) the manufacturer (a manufacturer seated in Serbia, or a representative office/branch of a foreign manufacturer seated in Serbia), or (2) the authorised representative of the manufacturer. The AR must hold a written authorisation signed by the foreign manufacturer and the AR, covering at minimum: keeping technical documentation and certificates; providing documentation to the Ministry/ALIMS on request; executing ordered corrective/preventive measures; informing the manufacturer without delay of complaints, quality defects and incidents; and filing the AR removal request when replaced. The applicant must have a person responsible for documentation and a person responsible for vigilance.

An importer from non EU countries may place on the market only devices for which conformity assessment has been carried out; before placing on the market it must verify that the manufacturer performed conformity assessment, appointed an authorised representative, prepared the declaration of conformity and technical documentation, that the device bears the conformity mark, is labelled with IFU and declaration, and carries a UDI or bar code where applicable. The importer is responsible for withdrawal of unregistered devices placed on the market under Art. 79 approvals.

The applicant must employ full time a person responsible for documentation (completed medical, dental, pharmaceutical, technological, electro technical, mechanical, chemical or legal faculty) and a person responsible for vigilance and market monitoring (same faculty types plus additional vigilance education). Exceptionally one person may hold both roles, decided by ALIMS depending on number of classes/categories represented and planned volume.

Registration and dealer's licences are held by Singapore registered entities identified by their ACRA issued UEN; foreign manufacturers place devices through a local registrant, and the same entity may act as registrant, importer and wholesaler if it holds each licence.

Changing the registrant of a registered device is a formal application under GN 24 (R2, 2025) submitted via SHARE; the current fee is S$880 with a 40 working day turnaround.

The manufacturer, EC representative, importer or distributor that makes the device available on the Slovak market is the obligated actor for the § 110b notification. If another subject files on their behalf, an original power of attorney from the manufacturer/EC REP/importer/distributor is required.

Health institutions and distributors (except distributors offering only the devices exempted under Art. 21(4)) must have a person responsible for regulatory compliance and a person responsible for reporting vigilance incidents; qualification requires at least one year of experience with regulatory requirements or a device related quality management system; the compliance person keeps records of tasks performed.

Importers must have in house at least one person responsible for regulatory compliance and at least one person responsible for reporting vigilance incidents; qualification: an 8th level (second cycle) diploma in law, medicine, pharmacy, engineering or another science, or at least one year of experience with regulatory requirements or a quality management system for medical devices.

An 'authorised representative' is a natural person, resident in South Africa, holding a written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider, in whose name the manufacturer licence, distributor licence, wholesaler licence or certificate of registration is issued, and who is responsible for all aspects of the device including performance, quality, safety and compliance with conditions of registration.

Changes to licence particulars (including the authorised representative) after issue of the licence require written notification to the Registrar under Regulation 5(7) and are processed as establishment licence amendments (SAHPRA MD10 2025/26 process); the amendment fee is R5,500.

Under Regulation 1 GN R1515: a 'manufacturer' is the natural or legal person responsible for design, manufacture, packaging and labelling before placing on the market under their own name (regardless of whether operations are outsourced), or any person who assembles, packages, reprocesses, refurbishes or labels ready made products or assigns their intended purpose; a 'distributor' imports or exports a registered device in its final form and places it on the market under its own name and sells to healthcare professionals, institutions, wholesalers or users; a 'wholesaler' purchases from a manufacturer or distributor and sells to a retailer.

archetype: licensed importer as applicant · name: Korean licensed importer / product authorisation holder · required for foreign: yes · registration relation: foreign device enters through licensed importer · importer relation: same core local role · distributor relation: may be separate · combination: allowed subject to business licences · detail: The importer must hold an import business licence from MFDS and is the party that obtains the product level import approval/certification/notification.

Manufacturing medical devices as a business requires a manufacturing business licence (제조업허가) from the MFDS Commissioner.

Selling or leasing medical devices is a notified business (판매·임대업 신고) with an official notification form (의료기기 판매(임대)업 신고서, [서식 36]) and a notification fee under Enforcement Rule Annex 10.

Distributors and sellers of devices established in Spain must make a prior start of activity communication to the health authority of the comunidad autónoma of their registered office (and of the warehouse, where located in another region); pharmacies are exempt unless they perform individual adaptation activities.

An import licence from AEMPS is required both for importers established in Spain and for persons that physically introduce products into Spain without being the importer under the EU Regulation.

The applicant (manufacturer or importer) must give a written statement confirming responsibility for the safety, quality and effectiveness of the registered device, keep application information up to date, have a proper system to handle side effects or problems, carry out quality control checks and use suitable packaging materials.

All foreign medical device manufacturers must submit registration applications through a Marketing Authorization Holder (local agent) in Sri Lanka who is responsible for registration, licensing, importation, sale, distribution, handling of quality failures and all aspects pertaining to the device in Sri Lanka.

Distributors and importers responsible for translation/re labelling or repackaging under MDR/IVDR Art. 16.2 16.4 who sell on the Swedish market must register the activity with Läkemedelsverket, stating product names and the legal manufacturer (voluntarily EMDN category and UDI DI); other distributors and contract manufacturers must not register nationally.

archetype: manufacturer mandated authorized representative · name: Swiss authorised representative (Bevollmächtigter, CH REP) · required for foreign: yes for foreign manufacturer · legal basis: Art. 51(1) MedDO; Art. 44 IvDO · mandate: must be agreed in writing; the CH REP is responsible for formal and safety related matters vis à vis Swissmedic · registration relation: registers as actor in swissdamed and covers the mandated devices · importer relation: separate registered actor (Art. 4(1)(h) MedDO) · distributor relation: separate supply chain role (Art. 4(1)(i) MedDO) · combination: roles may be combined if each is fulfilled and registered

path code: swissdamed mandate inactivation and new mandate · mandate recording: mandates are recorded per device in swissdamed Actors (not yet mandatory, but Swissmedic can request publication via Art. 51(3) MedDO in conjunction with Art. 11(3) EU MDR) · inactivation: an inactivated mandate cannot be reactivated; a new mandate must be created and devices relinked · reactivation of actor: a reactivation of the actor registration is possible after review by Swissmedic, subject to a fee, if revalidated within six months · fresh registration: no generic fresh conformity assessment · minimum handover: mandate inactivation/new mandate and device relinking; device registrations; complaints/vigilance/recalls continuity; CH REP label update; importer links

Contract manufacturing means entrusting the full process (manufacture, packaging, labelling, sterilisation and final release) or the manufacturing/sterilisation steps to another device manufacturer. It requires prior approval from the central authority with the parties' business licences, the contractor's manufacturing permit (excused for items exempt under Act Art. 22(2)) and a written contract stating names, agreement, classified device items, processes and the parties' rights and obligations; the approval is registered, changes are filed within 30 days. Labels, IFUs and packaging of fully contracted products must carry both parties' names and addresses (the contractor's may be replaced by country/region where already recorded in the registration system). Product violations are the responsibility of the commissioning party.

Where a distributor outsources import, storage, transport, sale, protection or servicing to another party, the arrangement must be covered by a written contract and monitored wherever it can affect GDP conformity; the related distribution records are subject to the same retention duty. The distributor must take measures ensuring the contractor complies with the contract, the GDP Regulations and other law.

Foreign manufactured devices are placed on the market through a locally registered medical device firm acting as importing agent and licence/filing holder: QMS inspection and manufacturing permit applications for imported devices must be filed by the importing medical device firm (代理輸入之醫療器材商), which is recorded on the manufacturing permit; imports must be made by the licence owner, filer or their authorised party; medical device firms must be approved and registered locally before operating.

A change of licence owner (許可證所有人, transfer/移轉) is an itemised change requiring prior approval from the central authority with the documents of Annex 4 and the change fee; the official processing time limit for transfer cases is 60 calendar days.

Where a manufacturer entrusts manufacture, processing or services to another party (受託者) for processes that can affect product conformity, a written contract must be concluded and the arrangement monitored. The manufacturer must take measures ensuring the contractor's processes comply with the contract, the QMS Regulations and other applicable law.

The applicant must be a Tanzania resident licensed by TMDA as a medical device dealer; a non resident applicant must appoint a Local Responsible Person (LRP, also called Authorized Representative or Local Agent) a company incorporated in Tanzania and authorized by TMDA to deal in medical devices with proof of official appointment submitted during the marketing authorization process.

path code: registration dossier transfer with consent · fresh registration: new application using transferred dossier · minimum handover: declaration of identicality; consent to dossier transfer (letter of consent); safety declaration; registration dossier (Full CSDT) · notes: The transferee files a Full CSDT application; once it is approved the master registration is cancelled — transfer enables a new application rather than editing the holder field.

Medical device importers must appoint an import controller (ผู้ควบคุมการนำเข้าเครื่องมือแพทย์) who holds at least a bachelor's degree and has a residence in Thailand.

The applicant for a Tunisian device AMC is the Tunisian importer. For every importation the importer must sign the 'Engagement pour CTI' form (form identifier F OP2 001 FR, annex 1 to the procedure), and ANMPS issues the administrative AMC only after the importer presents a copy of the payment receipt and the undertaking signed by the gérant (manager) of the importing company. That is an enforceable named officer commitment, not an anonymous corporate filing. ANMPS's registration service page adds that either manufacturers or importers submit the design, manufacturing and performance information and the international conformity certificates.

Non Turkish manufacturers must mandate an authorised representative established in Turkey; the authorised representative provides information to the Kurum in Turkish and/or an EU official language accepted by the Kurum.

Before making a device available, distributors verify that it is CE marked with an EU declaration of conformity drawn up, that the manufacturer supplied information accompanies the device, that importers complied with their duties, and that a UDI has been assigned where applicable.

Before placing a device on the market, importers verify that the device is CE marked, that the EU declaration of conformity has been drawn up, and that an authorised representative has been appointed; importers also verify economic operator/device registration data in the electronic system within 2 weeks of placing on the market (Madde 30(2)).

Manufacturers provide, on request, all information and documentation needed to demonstrate device conformity in Turkish and/or the relevant EU official languages.

Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system ensuring compliance with the Regulation, proportionate to the device's risk class and type.

S.I. 2014 No. 29 reg. 27(3) lists who may apply: the patent holder, a licensed person, the manufacturer of the surgical instrument, or an agent authorised by the manufacturer or patent holder. It does not require the applicant to be resident in Uganda. The operative local actor requirement is instead in DAR/GDL/028 s. 4.3.1: a declaration by the authorised local technical representative of the applicant must be submitted for all applications, undertaking (a) to ensure all submitted documents are an accurate reflection of truth, collected and compiled through the right and legal channels, authenticated by signature and stamping of their source; (b) to be fully responsible for the product and the post market plan submitted for complaint handling or recall; and (c) to comply fully with NDA's requirements after placing the product on the market. The local technical representative is also the party that must submit corrected artwork where NDA requires labelling changes, and where NDA requires new artwork the product will not get marketing approval until the Local Technical Representative in Uganda submits it with a sample from the first consignment.

A manufacturer that is not a resident of Ukraine must appoint one authorized representative (уповноважений представник) responsible for placing devices on the market; the representative must be a legal entity or individual entrepreneur that is a Ukraine resident or registered under Ukrainian law, with a documented mandate from the manufacturer.

The persons responsible for placing devices on the market (manufacturers and their authorized representatives) are 'creators of register information' who must notify Держлікслужба of their location and provide a list and description of their devices for entry into the Register of responsible persons.

archetype: marketing authorization holder or registrant · name: Licensed marketing office, medical products manufacturer, contracted manufacturing company, or medical warehouse designated by the Marketing Rights holder · required for foreign: yes · registration relation: local eligible applicant holds or manages authorization · importer relation: import by at least two EDE licensed appointed importers, subject to Cabinet exemptions under Art. 22(4) · distributor relation: one or more licensed distributors; can be a separate channel · combination: allowed subject to licences

path code: minor change request and or ownership transfer approval · fresh registration: not required for marketing rights holder change · minimum handover: minor change request to EDE for a change in the Marketing Rights holder or manufacturing location (Art. 16(3)); EDE approved transfer of marketing approval ownership (Art. 17(2)); new import permit application for the new importing establishment (Art. 33(2)) · notes: Import/export permit ownership is never transferable; when the importing or exporting establishment changes, a new permit must be applied for.

For imported medical products, the Marketing Rights holder must appoint at least two EDE licensed pharmaceutical establishments as importers and one or more licensed distributors. A main establishment handles product licensing, pharmacovigilance and lifecycle management; all designated importing establishments must import during the calendar year. Locally manufactured products instead follow the storage/distribution arrangements in Article 22(2). The Cabinet may grant exemptions under Article 22(4).

A manufacturer established outside the UK must appoint a sole UK Responsible Person (UKRP) a person established in any part of the UK acting on behalf of the overseas manufacturer who registers the devices with MHRA and assumes specified manufacturer obligations (keeping conformity documentation available for inspection, cooperating on corrective action, terminating and informing the Secretary of State if the manufacturer breaches its obligations). MHRA accepts registration only where the manufacturer is based in the UK, so overseas manufacturers register through their UKRP.

A foreign establishment must designate a single U.S. agent (21 CFR 807.40) who must reside or maintain a place of business in the US (no PO boxes or answering services); the agent acts only as FDA's communication liaison assisting communications, answering questions, and helping schedule inspections and has no responsibility for adverse event reporting under 21 CFR part 803 or for submitting 510(k)s under 21 CFR 807 subpart E. The initial importer (21 CFR 807.3(g)) is a distinct establishment role with its own registration, MDR, recall reporting, and device tracking duties.

Changes in the U.S. agent's name, address, or phone number must be reported to FDA within 10 business days of the change (21 CFR 807.40(b)(3)); when a new agent is designated, FDA sends an automated consent confirmation email, and if the agent denies consent or does not respond within 10 business days the official correspondent/owner operator must designate a new U.S. agent; no fresh establishment registration is required for an agent change.

The MSP keeps a registry/habilitación of companies that are manufacturers, representatives, distributors and/or importers of the regulated medical products; under Decreto 3/008 the scope extends to companies that produce, import, store, distribute or perform repair/maintenance of such products. Foreign manufacturers therefore operate through an MSP habilitated local company (representative/importer).

Every company under Decreto 3/008 must have a responsible Director Técnico, a university professional (physician, dentist, pharmaceutical chemist, engineer or other competent professional), who evaluates products, trains staff, advises technically and co shares responsibility for compliance; registration applications must be signed by the legal representative and the Director Técnico, and both remain responsible for the product while it remains on the market.

The applicant is the developer, manufacturer, registration certificate holder, or a legal entity acting on their behalf under a power of attorney (ишончнома); where an application is filed through a representative, the power of attorney must be notarized, apostilled or consularly legalized.

Regulatory acts (e.g., advertising disclosure) are performed by the circulation number owner or an organization holding its written authorization; a standard power of attorney form (Mẫu giấy ủy quyền, Phụ lục V) and warranty capability certificate (Phụ lục VI, signed by the owner) are prescribed.

statement: An applicant who is not resident in Zambia must appoint a local responsible person with a power of attorney who is responsible for compliance with the regulatory requirements for non in vitro medical devices. The Annex I application form requires the details of the local responsible person (with the power of attorney attached) and the details of the authorised local distributor (with the letter of appointment attached); a contact person responsible for communicating with the Authority must also be designated, with a letter of authorisation to communicate on the applicant's behalf. The applicant remains responsible for the product information supporting the application and its variations. The IVD guideline similarly requires an applicant not resident in Zambia to nominate a local representative, and permits a nominee of the applicant to submit with a copy of the power of attorney.

statement: MCAZ states that 'a manufacturer, or a local distributor can register condoms/gloves for distribution in Zimbabwe'. The application forms themselves do not impose a residency requirement on the applicant: Form M.C.Con.1 asks for the particulars of the applicant and its registered office, the name and physical address of the manufacturer, whether there are alternative places or sources of manufacture, and separately the name and address of the importer (if different from the applicant) and of the distributor (if different from the applicant). No local responsible person, authorised representative or power of attorney requirement appears in the device regulations or forms.