Special access & derogation by country

Two derogations exist: (1) the minister may, on a reasoned request, allow the placing on the market and use of particular devices for which the conformity assessment procedures were not followed, provided use is absolutely necessary for the protection of public health (Art. 17(4)); (2) the minister may, by special authorization order, allow the putting into service of medical devices for special cases defined by his order (amended Art. 13(8)). Custom made devices are exempt from CE marking and follow the Annex VIII declaration procedure.

The one statutory exceptional use instrument in Algerian health law is the autorisation temporaire d'utilisation (ATU): it may be delivered by the minister charged with health, after the opinion of the National Agency for Pharmaceutical Products (ANPP), for médicaments non enregistrés — unregistered medicines — when those medicines are prescribed in the treatment of serious diseases, where no equivalent treatment exists on national territory and where they present proven therapeutic utility. The ATU is therefore defined by reference to medicinal products, and Loi 18 11 defines médicament (Art. 208) separately from dispositif médical (Art. 212), so the route does not extend to medical devices. Its implementing modalities are fixed by regulation.

Unregistered devices may be imported for a named patient whose disease endangers life or quality of life (uso compasivo), under individual ANMAT authorization through the TAD portal (free, fully online). The dossier includes the device history (foreign authorizations with diplomatic legalization, ongoing foreign trials), a publication indexed in Index Medicus, a risk/benefit justification signed by the treating physician and endorsed by the ethics committee, and signed informed consent; documents must be signed and stamped on every page by the responsible physician.

Custom made devices (productos médicos confeccionados a medida, under the conditions of Anexo IV) are exempt from registration; they must be manufactured under BPF by habilitated establishments and carry the special label (rótulo especial) conforming to the model of Anexo V.

Devices without Armenian state registration may be imported in defined cases: the categories exempt from mandatory registration (devices under Article 4(11) of the EAEU Agreement, humanitarian and charitable programme devices, devices demanded in emergencies or under martial law, and state needs devices); devices imported in the name of an individual patient for that patient's course of treatment (including on vital indications), for health maintenance or for personal use, in the procedure established by the authorised body, carried by a carrier or sent by international mail; devices intended for exhibitions, conferences or similar events without the right of subsequent sale, subject to destruction or re export; and devices intended for examination for state registration or for changes to the registration documents.

Unapproved medical devices may be supplied for individual patients under the Special Access Scheme: Category A (notification by a medical practitioner for seriously ill patients), Category B (prior TGA approval; processed in about 2 5 days; generally inappropriate for reusable multi patient devices), and Category C (established history device lists, notification); the Authorised Prescriber scheme and clinical trial schemes are alternatives.

Applications for exemptions in the interest of health protection under Art. 59 MDR / Art. 54 IVDR must contain per § 12 MPG 2021: the exact designation of the required device including accessories, the justification to what extent use of the device is required in the interest of health protection, evidence that no equivalent CE certified device is available, confirmation that the essential safety and performance requirements are met (otherwise a detailed benefit risk assessment), and the intended conditions of use; extension applications must demonstrate continuing need.

No exemption permit is required where a self employed physician or dentist established in Austria certifies that a device without completed conformity assessment is needed for an individual patient to avert a danger to life or a serious deterioration of health and that no conforming device achieves the treatment outcome; the same applies to use by the Austrian Armed Forces and its immediate preparation.

Article 9 1.7 of the Law on Medicinal Products names medical devices expressly: where medicinal products and/or medical devices, as well as medicinal substances, intended to be displayed at an exhibition are temporarily imported, the following documents are added to the application: (9 1.7.1) where the applicant is a legal person, a copy of the extract from the state register of legal persons, and where the applicant is an individual entrepreneur, a copy of the identity document; (9 1.7.2) a copy of the certificate of registration of the applicant as a taxpayer; (9 1.7.3) a copy of the invoice; (9 1.7.4) a copy of the letter (document) of the exhibition organiser recording the applicant participating in the exhibition and the samples the applicant will display. Article 9 1.8 provides that the samples of medicinal products and/or medical devices, as well as medicinal substances, temporarily imported for display at an exhibition are returned within no later than 14 (fourteen) calendar days after the exhibition ends; those samples may not be sold, and their packaging must carry the words 'Nümunədir, satıla bilməz.' Article 9 1.16.2, written for medicinal products ('dərman vasitələri'), lists products intended for display at an exhibition among the exceptions to the requirement that an imported product be entered in the state register; its extension to devices is by analogy with 9 1.7 and 9 1.8 rather than by express words.

Circular No. (1) of 2022, issued under Resolution No. (48) of 2020, exempts from registration: devices imported for a healthcare facility for an emergency or on a single occasion and not planned for regular importation; devices imported for research and educational purposes; personal imported devices; custom made devices or orders for a specific patient; and samples for exhibitions and conferences. Authorized representative warehouses already licensed by the pharmaceutical products regulation section are also exempt from facility registration.

Custom made devices may be placed on the market if accompanied by a statement available to the particular identified patient or user; non conforming devices may be shown at trade fairs, exhibitions and demonstrations with a visible sign that they cannot be marketed until compliant, and such imports can be re exported after the purpose is served.

In sudden disaster, epidemic outbreak or national emergency need, a registration certificate may be granted without the prior recommendation of the Drug Control Committee, subject to prescribed conditions.

The import prohibitions do not apply, under prescribed conditions, to small quantities imported for testing, analysis, research or personal use, nor to imports of any drug to meet a national crisis.

Devices supplied in limited quantity may be registered via a dedicated route (procedure 9.3.5) where they are: supplied to state healthcare organizations for international health programs; needed for use in emergencies or for diagnosis of new, natural focal or especially dangerous infections; or delivered as foreign gratuitous aid. The certificate carries the 'ОК' mark; the file adds supply contracts to the standard documents.

The Ministry of Health may issue a permit for the sale and/or medical use of unregistered medical products; devices imported by an individual for personal use are exempt from registration. Residents of the China Belarus industrial park 'Great Stone' may obtain admission of unregistered devices for medical use (procedure 9.141.2, 15 days, free of charge).

Under Article 59 MDR / Article 54 IVDR the FAMHP can authorise the placing on the market / putting into service on Belgian territory of a non CE marked device where duly justified and in the interests of public health or patient safety or health (including absence of an alternative and significant expected benefit). The applicant can only be the manufacturer, its authorised representative, or a person duly mandated by them (mandate proven by a contract signed by both parties). Applications use the compassionate use form (second part completed by the treating physician) or the national derogation form, sent electronically to derogation.meddev@fagg afmps.be. No derogation request can be submitted for an off label use.

Under the Law of 22 December 2020 (implementing MDR Art. 17(3) and Implementing Regulation 2020/1207) health institutions may reprocess single use devices for further use; at the institution's request an external reprocessing company is permitted provided the devices are returned in full to the institution. Reprocessing is prohibited for certain devices (e.g. radiation emitting, administering cytostatics/radiopharmaceuticals, devices with medicinal substances, TSE risk devices, implantable devices, devices with non replaceable batteries). The institution notifies the activity via the FAMHP web portal ('My devices'), providing the UDI ID of the initial device (if applicable), the external reprocessor's contact details, the original manufacturer/trade name, the notified body certificate under Art. 17(5) and the Art. 5(5)(e) declaration; the information is published publicly.

statement: AGEMED published, and operated during Bolivia's COVID 19 health emergency, an 'Obtención de Registro Abreviado y Homologado' procedure, set out as two summary flow chart tables. For 'productos UTI COVID' the whole procedure was clocked at a 15 hour total, and for 'productos COVID' at 10 days. Both run the same six steps: reception of the file through the MISA platform with generation of an invoice and a routing sheet (maximum 2 hours after the company sends the request); evaluation by the professional evaluator of the authorisation department, with the file either approved, observed (the company remedies the observation and re enters evaluation) or rejected; printing of the Registro Sanitario; issuance of the certificate with the signatures of the head of the authorisation department and of AGEMED's Director General Executive (maximum 4 hours); digitisation of the certificate (maximum 2 hours after issuance); and delivery of the certificate at the counter (1 hour after digitisation), with the file archived by AGEMED and CONCAMYT. A 'reingreso con pago de 2° evaluación' step applies where the file was observed. · article: Tabla resumen, both tables

It is not necessary to mark medical devices that are intended for clinical investigation, or that are made to order for an individual patient or user.

MRSA 2013 s.23(3)(a) gives the Authority power to exempt in writing any medicine or cosmetic from the registration requirement in special circumstances; because 'medicine' includes any medical device, this is the statutory basis for BoMRA's exemption from registration guideline, which states in terms that section 23(3), (4) and (5) provides for the Authority to exempt medical devices from registration under special circumstances.

Where BoMRA finds that a product complies with all the requirements for safety, quality and performance it will be exempted and listed, and an approval letter issued to the applicant. The validity period of approved products is six months unless revoked by the Authority or terminated by the applicant; the list of approved/exempted devices and applicant details is published on the BoMRA website monthly or as necessary.

The ANVISA anuência for manufacturing/importing a custom made device must be requested at least 30 days in advance.

Custom made devices do not require registration under RDC 751/2022 but remain subject to prior sanitary control through ANVISA anuência to manufacture/import and to manufacture/import notification.

The exemptions in s. 18 of the Medicines Act (research or registration samples, pharmacy dispensing, teaching institutions, clinical trial or registration samples, and manufacture or import 'solely for the purpose of treatment of any person suffering from a life threatening illness') and the Ministry of Health's Import Permit with Special Approval all relieve the s. 10(1) duty for medicinal products. Because devices are outside s. 10(1) altogether, no special access, named patient or emergency use derogation exists or is needed for a medical device.

The Minister of Health may, by an exceptional order (заповед по изключение), permit a medical device to be put into use even where the conditions of ЗМИ Art. 8 are not met.

Custom made medical devices are expressly not subject to product registration requirements. A custom made device is one specifically made in accordance with a duly qualified medical practitioner's written prescription giving specific design characteristics under the practitioner's responsibility and intended for the sole use of a particular patient; mass produced devices adapted to a practitioner's or other professional user's specific requirements are not custom made devices.

Notwithstanding the registration and conformity assessment duties, the Regulatory Authority of a Member State may, on a duly justified request or on its own initiative, authorise the use within its territory of medical devices that have not undergone registration, where that use is in the interest or protection of public health.

No person shall import or sell a Class III or IV custom made device or a medical device for special access unless the Minister has issued an authorization for its sale or importation (MDR Part 2 route, outside the MDL system and exempt from MDL fees).

ISP's Director may authorize the sale or provisional use of devices governed by D.S. N°825/1998 without prior verification of conformity in situations of national emergency or where the population urgently requires the product.

Devices for rare diseases, life threatening conditions without effective treatment, or public health emergencies may receive conditional approval (附条件批准) with the conditions recorded in the registration certificate; for emergency use, NMPA may, after organized assessment and consent, permit use of devices within a defined scope and period.

Products not complying with the decree may be shown at fairs, expositions and demonstrations if previously authorized for that purpose; they cannot be marketed or put into service without the corresponding registration/permit, and demonstrations may never involve use in patients when the product is not approved in the country of origin or reference countries.

INVIMA may exceptionally authorize import of finished devices without a registro sanitario or permiso de comercialización, on request accompanied by a free sale certificate from the origin country, proof of the petitioner's existence and representation, and a product quality certificate, in three cases: (a) calamity or emergency determined by the Health Ministry; (b) devices/controlled equipment with authorized clinical investigation in Colombia; (c) vital unavailable devices (unless in clinical investigation or with market substitutes), for which the patient's full name and clinical history summary are required.

Donations of EMB are within the regulation's scope, and any use of a donated EMB that has not been approved by the Ministry of Health under the established requirements and procedures is prohibited.

Sanitary authorizations for customs release (desalmacenaje) of unregistered EMB exclusively for clinical research purposes are excluded from the application of RTCR 505:2022.

The AIRP has adopted Décision n° 0005/AIRP/DG du 26 février 2026 fixing the conditions for granting an authorisation to use non homologated pharmaceutical products in a public health emergency (published on the AIRP official document index on 4 March 2026). The modalities are set in guidelines annexed to and forming part of the decision (art. 2); the authorisation is valid for twelve months, renewable once (art. 3); it may be modified, suspended or withdrawn, and in case of a public health risk withdrawal or suspension is pronounced immediately by the Directeur Général (art. 4). It is the national emergency use instrument sitting alongside the UEMOA requirement that each member state operate an authorisation regime for products used outside routine authorisation.

The competent authority must put in place a mechanism for managing donations, comprising the authorisation, control and import of medical devices. Nationally, the AIRP has adopted a decision fixing the conditions for managing and issuing the import authorisation for donations of pharmaceutical products in Côte d'Ivoire (published on its official document index, 18 February 2025): any person wishing to donate pharmaceutical products must first obtain a donation authorisation from the AIRP (art. 1), beneficiaries are approved health establishments (art. 2), donated products must meet the quality standards of the country of provenance and of Côte d'Ivoire and donated medical devices 'doivent absolument être de bonne qualité' (arts. 3–4), the request is addressed to the AIRP Directeur Général with the listed documents including the full list of donated pharmaceutical products and/or biomedical equipment (art. 7), and must be filed before shipment (art. 8).

On a justified request and with the consent of the health minister, HALMED may authorise the placing on the market or putting into service of medical devices and in vitro diagnostic medical devices for which conformity assessment procedures have not been carried out, where this is in the interest of public health, or of safety or health of patients. The authorisation is granted or refused by decision against which no appeal lies, but an administrative dispute may be initiated; HALMED informs the European Commission and the other member states of the authorisations granted. This is the national implementation of the MDR Article 59 / IVDR Article 54 derogation and is the only route by which a device without CE marking — including a device holding only an FDA, PMDA, MFDS or NMPA approval — can lawfully reach the Croatian market.

Under E 132 25 epígrafe 3.55, in crisis or emergency situations, supply shortages or other public health relevant situations, CECMED may decide not to follow the regulatory processes or routine investigation procedures, and may authorize reduction or exemption of fees, taxes or tariffs. Epígrafe 3.59 allows CECMED to authorize unregistered devices for trade fairs and exhibitions. Resolución CECMED No. 119/2025 establishes rapid response protocols for epidemics, natural disasters, energy crises and shortages of medicines, equipment and devices, derogating Circular CECMED 1/2020 and 2/2020.

ER 16 (CECMED, 18/12/2012), based on Article 103 of the Reglamento (RM 184/2008), governs the Permiso de Uso Excepcional en Seres Humanos for investigators/designers of medical equipment linked to the SNS or priority health programs. The dossier includes the application form, justification, pilot study plan (per NC ISO 14155), safety/efficacy evidence with risk analysis, operation/maintenance manual draft, scientific council aval signed by at least 90% of members, and host institution acceptance with ethics committee aval. CECMED decides within 60 working days and the permit is valid up to two years.

A device may be placed on the Cypriot market or put into service without the conformity assessment procedures of Article 52 only under an authorisation granted by the competent authority, the Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), on a duly justified request and where the use of the specific device is in the interest of public health or patient safety or health (MDR Article 59(1)). Where the authorisation is granted for use other than for a single patient, the Member State must inform the Commission and the other Member States (Article 59(2)); following that notification the Commission may, in exceptional cases, extend the authorisation to the territory of the Union by implementing act (Article 59(3)).

The Ministry of Health may, on a healthcare provider's application, authorise putting into service a device for which conformity assessment procedures were not carried out, where (a) use is necessary given the health condition of a specific patient or group, (b) no conforming device is available on the market, and (c) use is in the interest of patient safety or health.

SÚKL may, on application by the manufacturer, authorised representative or importer, authorise the placing on the Czech market, putting into service and use of a specific device that did not undergo conformity assessment, where its use is in the interest of public health protection or safety or patients' health; the decision sets the period and conditions. The application must state and evidence the grounds for the exemption.

Denmark operates the MDR Article 59 / IVDR Article 54 derogation: DKMA may authorise, for a limited period, the making available of a specific device on the Danish market without conformity assessment where public health or patient safety so requires. The application (by manufacturer, authorised representative or authorised person/company) must document the Danish health professional's assessment of need and consequences, recipients, device types/models, unit numbers, required duration, and alternatives on the market or alternative procedures.

statement: Dominican law empowers the health authority, in situations of emergency resulting from a disaster of any origin, to dispense temporarily with the application of the sanitary control regulations. The power sits in the common provisions chapter of the sanitary control book, in which the health authority is assigned the sanitary control of the process, use, maintenance, import, export and final disposal of medical equipment, prostheses, orthoses, functional aids, diagnostic agents, dental supplies and surgical and healing materials, so those products are within the chapter's subject matter. · article: Art. 113 (con Art. 109(b))

Resolución ARCSA DE 016 2020 LDCL (subscribed 2020 07 01, published R.O. Edición Especial 770, 2020 07 13) issues the substitute norm authorizing import by exception and import by donation of medicines, biologicals, medical devices and IVD reagents, covering products without Ecuadorian registration in cases of emergency in the National Health System, state of exception, or international health emergency, and donations with or without registration.

The national health authority, through its competent entity (ARCSA), may authorize importation of devices and IVD reagents that have no Ecuadorian registration: in health emergencies; for patients needing specialized treatments unavailable in the country; for catastrophic, rare or orphan diseases; for human clinical research; for public sector supply through international organisms; for donations accepted by the health authority; and other defined cases.

Separate import approval routes exist for devices used in exhibitions, workshops and training; devices imported for a research protocol; production inputs, components and raw materials for local device factories; and customs release of registration samples. For the exhibition, workshop and training route, failure to complete requested documents within 32 days stops review and causes rejection; 32 days is not the authority's review time.

A Special Import Requests Evaluation Unit handles imports where the device is: a donation for hospitals, imported by a hospital, by individuals for personal use, by a physician, by a company without medical device import activity, or by a medical device company for a hospital or patient. Applications go via MeDevice (response in 3 working days); the Import Committee accepts, postpones or rejects with reasons, and approval is valid one year.

By way of derogation from the conformity assessment procedures, a competent authority may authorise, on a duly justified request, the placing on the market or putting into service within its own territory of a specific device for which those procedures have not been carried out, where use of the device is in the interest of public health or patient safety or health. In Estonia that authority is Ravimiamet.

Notwithstanding the general prohibition on importing, manufacturing, storing, distributing, transporting, selling, holding, using or transferring an unregistered and unauthorised device, the executive organ may in compelling circumstances grant a permit for the importation or use of an unregistered medicine or medical device. This is the statutory basis of the special import route for unregistered devices; EFDA's implementing guidance cites it and Regulation No. 531/2023 Art. 5(10) as its legal basis.

An individual who wants to import medical products for personal use or a custom made medical device must have a prescription paper from an authorised health professional indicating the type, description and quantity of the medical products. In this case no pre import permit application is required and the applicant can clear the product at the port of entry by showing the prescription paper. EFDA's pre import permit rules state the same: pre import permits are not required for medical products imported for personal use, including custom made devices.

EFDA does not require registration of medical devices intended to be used in four circumstances: custom made and personal use devices; devices for national health emergency; investigational devices; and devices for research, demonstration, training, education and other non clinical uses. Devices in these categories must not be imported or placed on the market without EFDA's prior approval, and applicants are directed to the guideline for importation of medical devices through special access for that permission.

Where a device to be donated has been registered by EFDA, the recipient must liaise with the company holding the marketing authorization for the purposes of safety monitoring. Where the device is not registered in Ethiopia, EFDA permits importation of the donated product if the pre import requirements in the donations guideline are complied with, so that EFDA can monitor the safety of the device while it is used in the country and, as applicable, test it. An applicant who wants to import or receive a medical device as a donation must hold a pre import permit from the Authority, applied for through the eRIS system with the donor recipient agreement, the recipient's certificate of competence or licence, a supporting letter from the Federal Ministry of Health or the regional or city administration health bureau, the device QMS certificate (ISO 13485) as appropriate, the proforma invoice, the donation certificate, the certificate of origin and, if applicable, the certificate of analysis.

By way of derogation from Art. 52 MDR, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within its Member State of a specific device for which conformity assessment procedures have not been carried out, where use is in the interest of public health or patient safety or health; the Member State informs the Commission and other Member States where the authorisation is not for a single patient, and the Commission may extend the authorisation Union wide for a limited period via implementing acts (Art. 59 MDR).

Custom made devices follow the Annex XIII procedure: the manufacturer draws up the statement set out in Section 1 of Annex XIII before placing them on the market (no CE marking); class III custom made implantable devices are additionally subject to Annex IX Chapter I conformity assessment or alternatively Annex XI Part A (Art. 52(8) MDR).

Devices manufactured and used only within health institutions established in the Union are exempt from the MDR's requirements (except the applicable GSPR) if all conditions are met: no transfer to another legal entity; manufacture and use under appropriate QMS; documented justification that the target patient group's specific needs cannot be met by an equivalent device on the market; information to the competent authority on request; a publicly available declaration; detailed manufacturing/design documentation; conformity manufacture measures; and review of clinical experience with corrective actions. Industrial scale manufacture is excluded (Art. 5(5) MDR).

The written order (prescription) required to manufacture a custom made device may be issued only by a health care professional as defined in the Act on Health Care Professionals (559/1994) who has the competence and professional skill required by the device's intended purpose; Fimea may require custom made device manufacturers to compile a list of devices manufactured and deliver it to Fimea.

Fimea may grant, on application, a time limited exemption permit to place a medical device on the market or into use even though the conformity assessment procedure under MDR/IVDR has not been carried out, if the device is necessary to protect public health or to treat or relieve a patient's illness or injury, no other equivalent CE marked device is available, and the applicant demonstrates that the general safety and performance requirements are met; a permit may also be granted in exceptional circumstances to secure availability of devices, and Fimea may attach safety conditions. The Ministry of Social Affairs and Health may permit marketing during an epidemic threat under the Communicable Diseases Act (1227/2016) 75 §.

ANSM may grant, in exceptional circumstances and in the public health interest, individual derogations (supply to a named establishment/professional) or global derogations (supply to any health establishment or professional in need, within a validity limit) for devices lacking CE marking; requests are filed on demarches simplifiees.fr and are admissible only if the benefit for patients is significant, with safety and performance data and no alternative on the market; ANSM monitors derogations and may withdraw the authorisation without delay on patient safety risk.

Non invasive contraceptive mechanical devices are exempt from the state regulation provided for by the Law on Medicines. Pharmaceutical substances, bulk and intermediary products, products prepared according to a magistral formula prescription and to an officinal prescription, and allergens designated for an individual natural person are not subject to registration. Complementary medicinal products, biologically active additives and paratherapeutic products are pulled into the Law's state regulation mechanisms only if the interested person voluntarily registers them under the national regime of state registration.

Under the conditions of MDR Art. 59(1) / IVDR Art. 54(1), the competent federal higher authority may, on reasoned application, authorise the placing on the market or putting into service of products for which the conformity assessment procedure under MDR Art. 52 has not been carried out (Sonderzulassung); BfArM grants this exceptionally where protection of health requires it.

The registration prohibition does not apply to an FDA import permit for articles imported for personal use, and does not prevent importation of a sample for purposes of registration.

In an emergency occurring or believed imminent, a request for consideration for an EUA is expected to be acted upon within 15 working days; the applicant must appoint a Qualified Person for Pharmacovigilance (QPPV) as a condition.

EUA allows FDA to authorise either an unregistered medical product or an unapproved use of a registered medical product during a declared Public Health Emergency; it covers allopathic medicines, biological products including vaccines, and medical devices, when there are no adequate, approved and available alternatives.

An EUA terminates one year from the date of issuance of the authorisation letter or when the Public Health Emergency declaration ceases to exist, whichever is earlier.

Devices manufactured and used only within health institutions established in the Union are exempt from the requirements of the Regulation, with the exception of the relevant general safety and performance requirements of Annex I, provided that: the devices are not transferred to another legal entity; manufacture and use occur under an appropriate quality management system; the health institution justifies in its documentation that the target patient group's specific needs cannot be met by an equivalent device available on the market; and the institution assumes all responsibilities and obligations established by the Regulation.

Acuerdo Ministerial 206 2021 defines 'uso compasivo' as the use of a medicine or medical device in isolated patients, outside a clinical trial, including pharmaceutical specialities for indications or conditions of use other than those authorised, under the exclusive responsibility of a physician who considers its use indispensable. To use a product as compassionate use under the conditions of the original clinical trial, a utilisation protocol prepared by the requesting physician is required, with the patient's or their representative's informed consent, a clinical report in which the physician justifies the need for the treatment, where applicable the conformity of the director of the centre where the treatment is to be administered, and the authorisation of the Department. The application to the Department must attach the clinical report and justification of the responsible specialist physician, the medical director's approval where applicable, the patient's informed consent, a bibliographic review of the product, and the reasons the patient cannot be included in an authorised clinical trial. The Department authorises the compassionate use on the documentation presented, and compassionate treatments cannot be dispensed on prescription because the product is not registered in the country.

Under the Greater Bay Area measure, designated healthcare institutions in the GBA may use, subject to Guangdong Province approval, Hong Kong registered drugs and medical devices used in Hong Kong public hospitals for urgent clinical use; as at 31 July 2026, 95 medical devices had been allowed in 71 designated institutions.

Where the conditions of IVDR Article 54(1) exist, NNGYK may upon application permit that the device be placed on the market without the conformity assessment procedures of IVDR Article 48 having been carried out (deviation permit under 8/2003. (III. 13.) ESzCsM rendelet 4. § (1)).

On duly justified public health/patient safety grounds, with conformity assessment already in progress and a determinable end date, NNGYK may permit deviation from conformity assessment procedures (eltérési engedély) under MDR Article 59(1) via 4/2009. (III. 17.) EüM rendelet 22. § (1); the permit may relate to a specific patient or be general for a manufacturer's specific device.

Iceland operates a national exemption route for a device without CE marking: an application for exemption from CE marking of a medical device (form 'Umsókn um undanþágu frá CE merkingu lækningatækis' on the Lyfjastofnun forms index), which the fee schedule describes as the assessment of an application to use a device that does not meet the quality and safety requirements, in the interest of public health or patient safety. The fee depends on the class: Class IIa devices and non invasive Class IIb and III devices ISK 200,250 (item 3.3); Class IIb and III devices including implantable devices, invasive devices intended for long term use and IVDs ISK 293,700 (item 3.4); other exemptions ISK 200,250 (item 3.5). Article 9(3) of the Act preserves Lyfjastofnun's power to withdraw a device from the market even where it is CE marked, if the device turns out to have dangerous properties.

Custom made devices are exempt from the licensing chapters (IV and V) where made to a duly qualified medical practitioner's written prescription, under his responsibility, for the sole use of a particular patient, and labelled 'custom made device'; mass produced devices merely adapted to user requirements are excluded.

Small quantities of investigational devices not otherwise importable but approved in the country of origin may be imported for treatment of a patient with a life threatening disease, disease causing serious permanent disability, or unmet medical need: application in Form MD 18 by a medical officer through the medical superintendent of a Government hospital or statutory medical institution; licence in Form MD 19; fee INR 500 per device.

In emergencies, disasters, extraordinary events (KLB), epidemics or health crises, health supplies may be circulated under an emergency use authorization (EUA) issued by the Minister (for devices) or the food and drug authority head (for drugs) within their respective mandates.

In defined circumstances devices and PKRT may be imported without an izin edar through the special route (jalur khusus) mechanism with the Minister's approval, for purposes of: healthcare services; research needs; government programmes; social service (bakti sosial); exhibitions; personal use; and other needs determined by the Minister. Personal use and certain other imports (temporary import, re import of exports, foreign representative needs) may proceed without the Minister's approval via courier/postal services, passenger baggage etc.

A dedicated process exists for research use goods: 'فرآیند صدور کد irc کالاهای تحقیقاتی' (process for issuing IRC codes for research goods) with a research goods registration guide.

The directorate operates a 'مجوز فروش موقت' (temporary sale permit) category, published as a public inquiry section on imed.ir alongside the other license inquiries.

Ireland exercised the IVDR Article 4(3) option: where a genetic test is used on an individual in the context of healthcare, the individual (or legally designated representative) must be provided with relevant information on the nature, significance and implications of the test; for untreatable conditions the person must be appropriately counselled, except where a diagnosis is confirmed by the genetic test or a companion diagnostic is used.

A person may not reprocess a single use device to make it suitable for further use in Ireland unless there is compliance with MDR Article 17(6), (7) and (8); a reprocessor assumes the obligations incumbent on manufacturers.

A private individual or physician fills their ID number details instead of importer details on the import application; attaches a prescription or physician guidance letter for purchasing the device; and attaches a declaration that the import is for personal use only. No regulatory approvals need be attached.

Devices listed in the Second Addendum to the Medical Equipment Law are exempt from registration: medical equipment may be manufactured and marketed only if registered (and per registration conditions) or if listed in the Second Addendum.

In exceptional cases of necessity and urgency under MDR Art. 59(1), the Ministry of Health may authorize, on duly motivated request, placing on the market or putting into service in Italy of specific devices for which MDR Art. 52 conformity procedures have not been completed, in the interest of public health or patient safety; the derogation is of limited temporal validity and may be subject to conditions. Health institutions, via regional health departments, may flag the need (Art. 11(4)); ISS and CSS support the assessment (Art. 11(6)); decision within 60 days (Art. 11(7)).

For treatment of single patients, in exceptional cases of necessity and urgency and absent valid medical alternatives, the Ministry of Health — with modalities set by a specific Ministerial decree — authorizes requests of the responsible health institutions to use devices for which conformity assessment procedures have not been carried out or completed, after acquiring specific declarations from the manufacturers.

MHLW may grant conditional approval (条件付承認) for rare disease (希少疾病用), pioneer (先駆的) or special use (特定用途) devices/IVDs, attaching conditions including implementation of Ordinance defined postmarketing surveys.

緊急承認: MHLW may approve devices/IVDs needed urgently to prevent spread of serious health harm where no adequate alternative exists, attaching use assurance conditions and a term not exceeding 2 years (extendable under the same article).

Medical supplies, sterilants or disinfectants imported in non commercial quantities or for specifically named patients are exempted from mandatory testing by decision of the Director General upon the committee's recommendation.

The requirements of the EAEU registration rules may not apply to devices the need for which arises or increases in emergencies, military action, threat of spread of dangerous new epidemics, or threat of absence of devices on member state markets.

Unregistered devices may be imported on the basis of a permit conclusion for provision of medical care by vital indications of a specific patient, or to a limited cohort of patients with rare and/or especially severe pathology.

PPB grants Emergency Use Authorization (EUA) as a risk based expedited pathway for products addressing urgent threats such as pandemics, epidemics and chemical, biological, radiological and nuclear incidents; eligible products include therapeutics, vaccines, blood products, biotherapeutics, in vitro diagnostics and critical medical devices. EUA is granted only where potential benefits outweigh the risks based on preliminary quality, safety and efficacy evidence and where no registered alternatives exist; the framework covers pre emergency planning, emergency phase authorization and post authorization safety monitoring with transition to full registration.

PPB's Guideline on Evaluation and Authorisation of Unregistered Health Products and Technologies provides a route for accessing unregistered products urgently required to address unmet patient medical needs; it applies to manufacturers, importers, healthcare providers, health institutions and licensed dealers, and authorizations are granted in compliance with the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, with eligibility/needs assessment, evaluation timelines, renewal procedures, record keeping and pharmacovigilance obligations.

statement: The State Agency of Medicines may authorise the placing on the market or putting into service of individual medical devices that have not undergone the conformity assessment procedures referred to in Article 52 of Regulation (EU) 2017/745, where the use of those devices is of essential importance for public health or for patient safety or health interests. The authorisation is granted for the time needed to carry out the necessary conformity assessment procedures, or until an alternative device becomes available, or until the use is no longer of essential importance. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: premarket review · localApplicationRequired: Yes · targetDecisionRetained: Yes

The registration process provides for the evaluation of registration dossiers for medical devices subject to special conditions, naming tissues dedicated to transplantation, medical devices containing components of animal origin, and coronary stents.

The Amt für Gesundheit grants exceptional authorisations for the placing on the market and putting into service of non compliant medical devices under MDR Art. 59 (EWR MepV Art. 18(2)(b)); EWR IvDV Art. 17(2)(b) assigns it the same power for non compliant IVDs under IVDR Art. 54. Fixed fee: CHF 1,000 per authorisation. For the customs union channel, Swissmedic issues exceptional authorisations valid for the whole customs territory.

The Minister of Health may, in exceptional cases where no equivalent or alternative devices conforming to Regulation (EU) 2017/745 (or the IVD rules) are available, permit devices to be placed on the Lithuanian market even though the conformity assessment procedures of those regulations were not applied, where the devices are needed to ensure health protection.

For requests to place on the market / put into service a medical device or IVD on Luxembourg territory by derogation from the conformity assessment procedures (MDR Art. 59 / IVDR Art. 54), the applicant must submit the completed 'Fiche de renseignement – demande de dérogation de procédures de conformité' form together with all relevant documents to meddevices@ms.etat.lu; only complete dossiers are processed.

Manufacturers of custom made medical devices must transmit to the Direction de la santé (meddevices@ms.etat.lu): the duly completed registration form (formulaire enregistrement mdr ivdr.docx); a recent RCS (trade register) extract; the declaration per MDR Annex XIII; applicable conformity certificates; QMS certificate where applicable; labelling and IFU where applicable; and documents demonstrating PRRC qualifications (Art. 15 MDR). They must also submit the list of custom made devices put into service in Luxembourg.

Seven categories of devices are exempt from registration/filing: (1) devices needed for public health emergencies; (2) devices for research or clinical trials; (3) samples or testing; (4) exhibition display; (5) imports to alleviate shortages; (6) custom made devices; (7) devices for diagnosis or treatment of a specific patient's special condition, with clinical interpretation by a qualified practitioner and ISAF approval. Categories (1) (5) and (7) require a special ISAF approval procedure with a dedicated form.

Class I and IIa devices imported solely for personal use with a value not exceeding the amount set by CE dispatch (MOP 5,000 per CE Dispatch 141/2026) are exempt from the import permit required by the External Trade Law (Law 7/2003).

A special access medical device is one for use by medical practitioners in emergency situations or where conventional treatment has failed, is unavailable or unsuitable; qualifying situations include emergencies, compassionate use, stockout alleviation and enhanced procedure outcomes. The applicant is the local manufacturer or the Authorised Representative; the exemption is valid for 6 months; after expiry/termination the devices must be disposed of, exported, or proceed to registration, with records kept as proof; a healthcare professional request letter is required (Annex C template).

Under the Medical Device (Exemption) Order 2024 (made under section 77 of Act 737), devices are exempted from registration for: personal use; demonstration for marketing; education; clinical research; performance evaluation; export only; import for re export; custom made devices; special access devices; orphaned, obsolete and discontinued devices. Categories (b) (i) require an exemption application to the Authority; importers/exporters of exempted categories (except special access) are also exempt from the establishment licence requirement.

By way of derogation from Article 52, the competent authority may authorise, on a duly justified request, the placing on the market or putting into service within Malta of a specific device for which the conformity assessment procedures have not been carried out, where its use is in the interest of public health or patient safety or health. The Authority charges EUR 1,000 for a derogation application and EUR 750 for its renewal, both under the Derogations group's 90 working day processing note, and EUR 500 for an application for use of a non CE marked device in Malta, which carries no special note and so falls under the 30 working day standard service.

Holders of oficios de excepción affected by the July 2025 low risk Acuerdo have a maximum of three years to obtain registration where required, in staggered windows (items 1 38 in 2025 2026; 39 75 in 2026 2027; 76 116 in 2027 2028; latest filing in 2029); exception letters lapse after five years.

Nine categories of medical device do not require registration: low risk devices other than IIa/IIb/III equipment, consumables and IVDs; spare parts; IVDs supplied under an external quality assessment contract; rare disease IVDs; devices for research; registration samples; devices for exhibition; devices for use in a disaster or serious public health situation; and devices received by international post or carried by a passenger for a citizen's personal use. The latter four categories may not be sold. Devices for disaster and public health emergency use and personal import devices are therefore exempt from registration but may not be placed on the market commercially.

statement: The Institute may authorise the import of medical devices that are not registered where there is an urgent medical need, for the protection of public health, and in the following cases: for research purposes, for clinical investigations, in the event of natural disasters, or other states of emergency. For such a device conformity assessment, or an equivalent assessment of safety and performance, must have been carried out under the Law. The application to the Institute states the name and quantity of the devices, the manufacturer's details, an expert opinion of the responsible person of the health institution for which the devices are imported, and data on the device's compliance. The Institute issues the decision within 30 days of receipt of a complete application. · reviewClockDays: 30

Where public health needs require it, and in an emergency, the government authority responsible for health may exceptionally authorise the placing on the market and putting into service of medical devices while the registration procedure is being completed, provided the manufacturer or importer justifies that the device has undergone verification of its efficacy, quality and safety under normal conditions of use.

During COVID 19, DFDA relaxed the import recommendation: (a) not requiring recommendation face shield, non medical use face mask, PPE, surgical/isolation gown (non sterile), BP cuff (manual), apron, examination glove; (b) temporarily not requiring thermometer (digital and non contact infrared), oxygen concentrator, pulse oximeter, oxygen nasal prong, oxygen face mask, BP cuff (digital); (c) still requiring infusion and suction pump, nebulizer, ventilator, patient monitor, surgical glove.

An exemption from the requirements of MDR art. 59(1) / IVDR art. 54(1) can be granted by the Minister of VWS on the basis of art. 8(4) Wet medische hulpmiddelen in combination with art. 4(2) Regeling medische hulpmiddelen; the IGJ advises on the application. Applications are made with a Dutch or English form sent by email to CIBGOntheffingenMedischeHulpmiddelen@minvws.nl; positive decisions are published in the Staatscourant.

The Netherlands permits reprocessed single use medical devices to be offered on the market only if they comply with the requirements set by or under the Wet medische hulpmiddelen; the Besluit medische hulpmiddelen (arts. 4 7) sets the national conditions for reprocessing and further use of single use devices, implementing MDR art. 17.

Custom devices — manufactured in response to a registered health professional's request specifying the design characteristics and intended for use only in relation to a particular patient (Schedule 1(b)) — and devices supplied to a practitioner for use in relation to a particular patient (Schedule 1(c)) are exempt from WAND notification.

A medical device imported by a person solely for that person's own use is an exempt medical device (Schedule 1(g)) and need not be notified to WAND; all other Medicines Act requirements still apply.

No donated medical product (drugs, devices incl. IVDs) may be imported into Nigeria unless it has undergone due processing with NAFDAC under the donated products guideline and a Permit to Import the specific donated items is issued; the recipient organization must demonstrate capacity (e.g. cold chain), liaise with the NAFDAC State Coordinator, and invite NAFDAC officers to witness use.

NAFDAC's EUA is a special procedure granting time limited listing authorization for unlicensed vaccines, therapeutics and medical devices (incl. IVDs) during a declared public health emergency, based on an essential set of available quality, safety and performance data; EUA is not equivalent to registration, and manufacturers are expected to complete development and submit for licensure.

NAFDAC issues a Permit for Service Drugs (including orphan drugs)/Medical Devices per product for special need devices that are not registered or not available in Nigeria, requested for use by expatriates or patients advised to use such brands.

By way of derogation, a healthcare institution may parallel import medical devices exclusively for its own needs. It may not place those devices on the market, but it may, with the prior consent of the Ministry of Health, transfer them to another public healthcare institution at the same price. A breach of this restriction is a criminal offence punishable by six months to five years of imprisonment.

Direktoratet for medisinske produkter may, in special cases, grant exemptions from provisions laid down in or under the Medical Devices Act, provided this does not conflict with Norway's international obligations, including the EEA Agreement.

DSC operates an 'Import Unregistered Medical Devices' service issuing permits to import non registered medical devices for the private market and government hospitals: 30 working days, no fee, conditions are an active related medical device activity in the commercial registry and local medical device establishment approval.

Rule 75 (added by S.R.O. 599(I)/2022 dated 27.04.2022) allows the MDB to grant emergency use authorization to medical devices in a public health emergency, national disaster, natural calamity or pandemic, subject to such procedure, conditions and validity as may be determined by the Authority on the recommendations of the MDB.

Under rule 24, small quantities of medical devices, including devices whose import is otherwise prohibited without enlistment or registration, may be imported for personal and hospital patients' use provided the device forms part of a passenger's bona fide baggage and is intended for the exclusive personal use of the passenger, with quantity restricted to personal requirement only.

Rule 2(lxvi) defines a 'special access medical device' as a medical device intended to be used by a qualified practitioner in an emergency or in a case where all conventional remedies have failed or are unavailable or unsuitable to meet any special needs arising in the course of his practice.

Decreto Ejecutivo 48 de 12 de abril de 2022 regulates donations of medicines, medical devices, biomedical equipment, medical furniture and other health products, repealing DE 988 de 8 de septiembre de 2015.

Upon supplier request technically supported by the requiring health entity, DNDM may authorize import of devices without a Registro Sanitario in five cases: (1) emergencies from public calamities and natural disasters; (2) humanitarian need for a patient with a pathology uncommon in the country; (3) unavailability of the device in the local market for public health needs; (4) research and teaching; (5) demonstrations at fairs and temporary exhibitions up to ninety days.

Resolución DINAVISA N° 203/2025 regulates the import authorisation for medicines and medical devices that have no Paraguayan sanitary registration, for compassionate use, covering products in the investigational phase and products already authorised by a foreign reference regulatory agency on the annual official list. The interested party must meet the technical and legal requirements of Art. 3.

Resolución DINAVISA N° 266/2022 Art. 16 authorises imports under the figure of 'Productos para Diagnóstico de Uso In vitro importados para uso propio' for users habilitated by DINAVISA as importers who import orphan IVDs — products no manufacturing laboratory has a commercial interest in because their development offers no economic incentive despite meeting health needs — and which are not among the Art. 13 exclusions.

The ANS through the ANM may provisionally authorize import, manufacture and use of devices without registration or outside registered conditions in five qualified cases: (a) declared urgency/emergency; (b) research exclusively; (c) training exclusively (devices only, time limited, authorized educational institution); (d) individual prevention/treatment with medical justification; (e) public health situations demonstrating need and non availability. Cases b/c/d require a declaration jurida application plus supporting documents.

Individual patients may import an unregistered device needed for their treatment through the 'Autorización Excepcional de Importación' with Visación de Receta, limited to prevention, individual treatment and emergency cases; it applies to natural persons for exclusive use of the patient, requires the medical prescription plus declaration jurada and a device characteristics report, and is free of charge.

CDRRHR issues a Compassionate Special Permit (CSP) for restricted use of medical devices not yet registered or in the process of registration, by patients in need of immediate medical attention; applicants include device manufacturers/importers, hospitals, attending physicians and DOH; requirements include letter of intent, physician profile, country of origin CPR (or local manufacturer LTO) and technical description; fee PHP 500 + 10 LRF; about 6 working days.

Investigational devices, non CE marked devices and medicinal products without marketing authorisation may be imported into Poland in the quantity necessary for a clinical investigation or performance study, on the basis of a URPL certificate confirming they are intended for the study (issued free of charge at the sponsor's request).

The President of URPL may grant, by administrative decision, a permit to place on the market or put into use in Poland a specific device that has not undergone conformity assessment procedures (MDR Art. 59(1)/IVDR Art. 54(1)) where its use is in the interest of public health, safety or patients' health. Eligible applicants: healthcare providers, national health consultants, the President of AOTMiT, the President of the National Health Fund (NFZ) and the President of the Government Strategic Reserve Agency (RARS); the application must state whether the device will serve one or more patients.

Upon duly justified request, INFARMED may exceptionally authorise the placing on the market or putting into service in Portugal of specific devices that have not undergone the conformity assessment procedures, where use contributes to public health or patient safety/health; the request is submitted electronically.

Under IVDR art. 54, ANMDMR may authorise, on a duly justified request, placing on the market or putting into service in Romania of an IVD for which the relevant procedures have not been carried out, where use is in the interest of public health or of patient safety or health.

ANMDMR may authorise, on request, placing on the market or putting into service in Romania of devices for which the conformity procedures of MDR art. 59(1) have not been carried out, in well founded public health or patient safety interest (e.g. epidemics, health crises, unavailability of an equivalent device); the national derogation is valid maximum 6 months, extendable, and the request is validated or rejected within maximum 30 days.

Unregistered IVD devices manufactured by a medical organization and used within that same organization may be applied under permits; Roszdravnadzor maintains a public registry of such permits.

Roszdravnadzor issues permits to import a medical device into Russia to provide medical care by vital indications for a specific patient.

The Authority may issue an authorisation for emergency use when a national public health emergency has been declared and the device meets one of the listed requirements: it is listed as prequalified or has been granted emergency use authorisation by the World Health Organization or the World Organisation for Animal Health; it is registered or has been granted emergency use authorisation by Stringent Regulatory Authorities; it is registered or granted emergency use authorisation by countries having collaborative agreements with the Authority; or the normal device registration process is ongoing and the Authority decides to grant emergency use authorisation based on the severity of the declared public health emergency. The emergency authorisation is issued following approval of the registration of the device under Article 17 as a certificate of emergency registration. A parallel article permits emergency use of an unregistered medicinal product or an unapproved use of a registered medicinal product.

SFDA may exempt devices from MDMA for humanitarian and research purposes in these cases: (A) public emergencies (natural disasters, wars, epidemics); (B) personal use per Art. 13.2 (medical report, limited quantities, no business purpose, prior SFDA approval); (C) research or educational uses; (D) approved pre marketing clinical trials; (E) custom made devices for a specific patient at the treatment team's request; (F) exhibition/festival/workshop samples. An SFDA import permit is required for all these exempted devices.

SFDA may exempt an innovative medical device from some conditions and procedures required for Marketing Authorization where this does not affect safety and performance. A device is innovative if it has innovative technology/use/performance characteristics with no similar technology in the local and international market, and a clinical/medical benefit exceeding available alternatives; eligibility is claimed via the Innovative Medical Device Summary Form (MDS REQ1 Annex 11), with relief from some Annex 3/4 documentation requirements.

Medical devices offered for sale or given as donations must comply with the essential requirements of the decree; donation is therefore not a derogation from the safety, quality and performance requirements.

Loi 2023 06 provides that import/export conditions for donated medicines are fixed by joint order of the Finance and Health Ministers (Art. 140) and that, by derogation from Art. 138, import/export authorisations may exceptionally be granted to private individuals under conditions set by decree (Art. 141); both are limited to 'médicaments'. For non medicine health products, including devices, import/export conditions are fixed by order of the Minister of Health (Art. 142), and the Law contains no device specific donation or individual import derogation.

Article 134 of the Law allows, for public health reasons and on an exceptional basis, derogations in the form of special authorisations for certain categories of medicines and other health products, notably temporary use authorisations (ATU) and temporary use recommendations; the conditions for granting them are fixed by order of the Minister of Health.

To prevent serious consequences for public health in an epidemic or other emergency, the Government, at the proposal of the Minister, may prescribe a different manner and conditions for placing devices on the market and their registration, clinical trials, manufacture, technical evaluation, labelling, vigilance, advertising and use than those prescribed by the Law.

The following devices are not registered: devices for which a clinical trial approval was issued; devices for continuation of treatment started outside Serbia for the personal use of a specific patient (on proposal of the competent healthcare professional of the country where treatment started); custom made devices (which must bear a manufacturer/AR special purpose statement and be labelled 'custom made'); devices for scientific research and development; devices temporarily imported for exhibitions and fairs (with a visible warning that trade/use is forbidden); and devices manufactured in a health institution for use in that institution.

Custom made medical devices and laboratory developed tests are exempt from the registration prohibition under reg 6, subject to the conditions in that regulation (manufacture exceptions in regs 3 and 3B).

Emergency medical devices may be manufactured, imported and supplied without registration under reg 13C where the Minister designates the device for Government use and the Authority is satisfied with preliminary and ongoing evidence of quality, safety and efficacy.

Unregistered devices may be brought in for special access under GN 35 (R5, Sep 2025); SAR applications ('New SAR Application') and SAR distribution record updates are submitted via SHARE, including for unregistered devices supplied for patients' use under reg 8.

Devices manufactured and used only within health institutions established in the Union are exempt from the requirements of the Regulation, with the exception of the relevant general safety and performance requirements of Annex I, provided that: the devices are not transferred to another legal entity; manufacture and use occur under an appropriate quality management system; the health institution justifies in its documentation that the target patient group's specific needs cannot be met by an equivalent device available on the market; and the institution assumes all responsibilities and obligations established by the Regulation.

Under Art. 59 MDR / Art. 54 IVDR, JAZMP may exceptionally authorise placing on the market or putting into use in Slovenia a device for which no conformity assessment procedure has been carried out, primarily in emergencies where use serves public health protection or user safety/health; JAZMP decides within 60 days of a complete application; application content is set by a JAZMP general act with health minister consent.

Custom made medical devices (made per a written prescription/order for the sole use of a particular user, excluding mass produced adapted devices) are exempt from registration (reg 11(2)) but must be manufactured and sold in compliance with the guidelines applicable to medical devices (reg 25), with permanent order/traceability records (reg 26).

Under section 21 of Act 101/1965, the Authority may in writing authorise any person to sell, during a specified period, to any specified person or institution a specified quantity of a particular unregistered medicine, medical device or IVD; use is restricted to the purposes, manner and period determined by the Authority, and the authorisation can be withdrawn at any time.

Investigational medical devices for clinical trials may be manufactured or imported without product approval, certification or notification, provided they are made in facilities meeting Prime Ministerial Decree criteria (and the trial plan is approved).

No person may repair, sell, lease, gift or use devices lacking the approval, certification or notification required under Articles 6(2) or 15(2); an exhibition exception is delegated to the Prime Ministerial Decree.

Only hospitals may manufacture devices for their own exclusive use, complying with MDR Art. 5(5); class IIb, class III and implantable devices may not be manufactured by hospitals; hospitals may not subcontract manufacture or sell the products; a prior start of activity communication to AEMPS (naming the responsible person, with the MDR 5.5(e) declaration and documents) allows activity to start subject to later verification; in a declared health emergency AEMPS may exceptionally authorize manufacture under different conditions.

NMRA operates a Waiver of Registration (WOR) mechanism for medical devices: applications (WOR form, request letter, invoices, LOA, product literature, labels, test reports, free sale certificate, ISO certificate, CE self declaration/EC certificate, plus e.g. TEC and procurement committee approvals where applicable) are submitted to the office of the State Ministry of Production, Supply and Regulations and Pharmaceuticals; incomplete applications are not tabled to the WOR Committee. NMRA publishes lists of issued WORs (e.g. IR thermometers, PCR kits, pulse oximeters).

A product placed on the market and taken into use under a granted dispens may not be sold or transferred to any care provider/user other than the one stated in the decision; the manufacturer (or its authorised representative) must inform users which products are covered by the dispens and any conditions Läkemedelsverket sets in the decision.

Läkemedelsverket may, on application, grant a national exemption (dispens) from conformity assessment/CE marking requirements under MDR Art. 59 / IVDR Art. 54, or from the national Swedish language requirement (3 kap. 3 § förordning (2021:631)), to protect patient/user life and health. Dispens is granted only for a specified number of units and for time limited use, is valid only in Sweden, and cannot be sought for purely commercial reasons or as an alternative to clinical/performance evaluation. Criteria: public health or patient safety justification, no equivalent compliant alternative on the Swedish market, safe use despite non compliance, acceptable benefit/risk balance. Application via e service in two parts (signed healthcare provider motivation plus manufacturer part with documentation).

Individual products that have not undergone the applicable conformity assessment procedure may be placed on the market and used without Swissmedic authorisation if: they serve to remedy life threatening conditions or permanent impairment of a body function; no conforming product is available for the intended purpose; they are applied to individual persons exclusively by medical professionals; the applying professional has informed the person concerned of the non conformity and its risks; and the person concerned has consented.

On reasoned application, Swissmedic may authorise the placing on the market and putting into service of a specific product in the interest of public health or patient safety or health, even though the applicable conformity assessment procedure under Art. 23 was not carried out or the language requirements of Art. 16(2) are not met.

Personal use import (無需醫師或專業人員操作、由自然人自行使用之醫療器材) is limited: consumables to a six month supply, instruments to one unit per model; expedited clearance for listed items and quantities is limited to once per half year (travellers carrying devices in personal luggage excepted). Applications require identification, instructions for use, an undertaking not to sell or transfer, and a diagnosis certificate or prescription from a domestic or foreign care institution naming the device.

Each project approval ground under Act Art. 35(1) has defined eligible applicants: (1) prevention/diagnosis/treatment of life threatening or seriously disabling disease — regional teaching hospitals or psychiatric teaching hospitals (with ethics approval, treatment plan, patient consent stating the device is unapproved, and quantity justification, foreign free sale evidence substitutable for technical documentation); (2) emergency public health response — government agencies, schools, institutions, legal persons or associations; (3) clinical trials — device firms, pharmaceutical firms or trial institutions (with ethics approval and trial documentation); (4) samples or gifts or personal use — the respective government/private/natural persons; (5) repair — repair distributors; (6) other device firms. Applications are decided on the stated grounds, benefit risk and quantity calculation, and may carry conditions.

Central authority project approval (專案核准) exempts manufacture/import from registration (Art. 25) in six situations: (1) prevention/diagnosis/treatment of life threatening or seriously disabling disease with no suitable domestic alternative therapy; (2) response to urgent public health events; (3) investigational devices; (4) samples, gifts or personal use; (5) import solely for repair where the repaired device will not be sold domestically; (6) necessary devices under Art. 34(4) announcements where manufacture/import cannot continue or supply is insufficient. Applicants include teaching hospitals, government bodies, firms, natural persons for personal use, and repairers; approval may be revoked and recall ordered (Art. 36).

Devices approved under the project regulations must be labelled per the approval letter, or marked 「臨床試驗用」 (clinical trial use), 「樣品」 (sample) or 「贈品」 (gift). For hospital, emergency response and firm grounds, the authority may require an actual use safety or performance evaluation report within a deadline; non submission or safety/performance concerns allow revocation of the approval. Use and disposal must not exceed the approved purpose, restrictions, method or time limit. Except for personal use imports and devices limited by their purpose, imported devices must be re exported within one month after the import reason ceases, with the customs re export evidence filed with the central authority.

Eligible applicants for TMDA medical device import/export permits include government and non government institutions, wholesalers, manufacturers, clinical trial sponsors, principal investigators and researchers, and recipients of donations.

Upon application, TMDA may authorise the sale, supply, import or export of unregistered drugs, medical devices or herbal drugs for a specific purpose; such authorisation carries conditions and may be withdrawn.

Import of medical devices for individual patients or animals (case by case) is exempt from the licensing/notification requirement.

No barrier is placed on supplying devices without CE marking: investigational devices meeting the conditions of Articles 62 80 and Annex XV, and custom made devices complying with Article 52(7) and Annex XIII (whose documentation includes the Annex XIII Section 1 declaration).

Upon a duly justified request, the Kurum may permit the placing on the market or putting into service of a specific device in the interest of public health, patient safety or health, in the context of health technology assessment or in emergencies (e.g. outbreaks).

The device registration guideline expressly excludes from its scope surgical instruments and appliances that are the subject of a patent application or a donation/gift; donated devices therefore fall outside the registration tracks and are handled under the donation rules of the import regulations.

Under Part III of the Importation and Exportation of Drugs Regulations 2014, importation for donation is allowed only where the recipient or donor informs NDA of the necessity directly related to the recipient's disease pattern, notifies NDA before shipment of the range, quantities, population served and recipient, and NDA authorises the importation in writing specifying the conditions; the donated product is verified on arrival, must come from a source approved by NDA and have at least one year of remaining shelf life at entry.

Section 8(3) of the Act prohibits importing or selling any drug not on the national formulary, but section 8(4) allows a drug not on the formulary to be imported and sold after authorisation by the Drug Authority to meet emergency or extraordinary circumstances.

Applicants may ask NDA for exemption from submitting product samples for large appliances or those that are extra expensive; NDA may then consider the product catalogue and/or a sample viewing instead.

Custom made devices follow the Annex 9 procedure with a manufacturer's statement instead of the standard modules, and devices intended for clinical investigations are exempt, together with custom made devices, from bearing the mark of conformity.

EDE may issue Emergency Use approval for medical products required by the State during a declared health emergency, epidemic or pandemic, as an exception to normal marketing approval conditions; validity lasts for the declared emergency period unless EDE specifies otherwise and may be extended or renewed.

On a duly justified request, in the interests of the protection of health, the Secretary of State may authorise placing devices on the Great Britain market without a UKCA/UK marking, subject to complied with conditions that may be withdrawn; refusals of such exceptional use applications (under regs 12, 26 and 39 of the UK MDR) can be appealed via the CIArb dispute resolution service. Custom made devices and devices intended for clinical investigation are exempt from the marking requirement, and devices displayed at trade fairs are not placed on the market if a visible sign indicates non compliance.

An investigational device that is not approved for marketing may be made available under a treatment IDE for patients outside the clinical trial when it is intended for a serious or immediately life threatening disease or condition, no comparable or satisfactory alternative is available, the device is under investigation for the same use (or the trials are complete), and the sponsor is actively pursuing marketing authorization. Treatment use may begin 30 days after FDA receives the treatment IDE unless FDA responds earlier in writing.

The MSP official trámite surface includes 'Solicitud de ingreso de un producto médico por uso compasivo'; the forms catalogue provides FO 13222 019 'Formulario de productos medicos no registrados' and FO 13222 020 'Formulario de Consentimiento Informado para el Paciente' for such entries.

In situations of sanitary emergency declared by the Executive, the MSP may issue a provisional registration for the medical products regulated by Decreto 3/008 (diagnostic reagents, therapeutic devices, medical equipment) that are manufactured, imported, marketed or distributed in the country, under a precarious and revocable authorisation regime; MSP determines the requirements companies must meet, and the registration may be revoked at any moment if the product does not offer sufficient guarantees of safety and efficacy.

Import without state registration is allowed for: devices for diagnosing and treating orphan diseases and for especially dangerous and epidemiologically dangerous infections imported by order of the Ministry of Health; and devices imported as external gratuitous aid and humanitarian assistance, which may enter and be used without registration subject to a positive Ministry of Health opinion.

Under MoH Order No. 24 (reg. No. 3749, 09.01.2026, in force 12.01.2026), medicines and devices in temporary shortage may be permitted for import and use in medical practice without state registration, subject to mandatory certification: a Permanent Working Group (with the Pharmaceutical Industry Development Agency, the Centre and the Procurement Center) decides, the product list is published on the Ministry website within 1 working day, importer proposals are submitted within 15 days, and quantities are sized at a 3 month minimum need.

Registration is not required for: reagents included in an IVD kit that cannot independently serve as a diagnostic means; custom made devices (индивидуал буюртма); and devices imported for scientific research, preclinical and clinical studies, or demonstration at exhibitions, fairs and international congresses. Devices intended for export may be registered at the applicant's option.

For medical devices serving epidemic prevention and control, natural disaster or catastrophe remediation in urgent cases on a list issued by the Ministry of Health, MOH grants a new emergency marketing number (cấp khẩn cấp số lưu hành) with a reduced dossier (application letter, a subset of the standard documents, and the free sale or marketing authorisation certificate). Emergency marketing numbers are the exception to the general rule that marketing numbers are valid without time limit.

Where the Minister declares a national health emergency or state of extreme urgency, where the public interest so requires, or where a product is needed for public non commercial use, ZAMRA may authorise local manufacture or importation of a generic formulation of a medicine or allied substance notwithstanding a Zambian patent; the authorisation cannot exclude the patent holder and is subject to court review.

Section 39(4) of the Medicines and Allied Substances Act 2013 lists the cases to which the marketing authorisation requirement of s.39(1) does not apply: donated medicines; personal or relative's use on prescription; import by a physician, dentist or veterinary surgeon on prescription; pharmacist compounded medicine; medicine imported or exported in response to a declared health emergency; medicine imported by an authorised institution for its patients; and any medicine or allied substance used for a clinical trial.

A person who intends to import any medicine or allied substance for personal use must apply to ZAMRA for a permit in Form II of the Schedule to SI 57 of 2017 and pay the prescribed fee. 'Personal use' includes use by the person's relative or animal.

The Importation and Exportation Regulations do not apply to a traveller entering Zambia with a medicine or allied substance for the traveller's own use, provided the traveller furnishes the port of entry inspector with written confirmation from the competent authority of the prescribing country that the product was prescribed for the traveller.

Section 75 of the Medicines and Allied Substances Control Act empowers MCAZ to exempt, in writing and subject to any conditions it specifies, any medicine or substance from the operation of any or all provisions of the Act; this is the legal basis for 'Section 75 authorisations' to import unregistered products.