Authority & regime by country

AKBPM (Agjencia Kombëtare e Barnave dhe Pajisjeve Mjekësore, National Agency of Medicines and Medical Devices) is the specialized institution for registration of medical devices, inspection and adverse event reporting; it is subordinate to the minister responsible for health.

The minister responsible for health takes the final decision on licences for domestic manufacture and wholesale trading of devices, may suspend or revoke them, orders withdrawal/restriction of risky devices on AKBPM proposal, and may authorize placing devices into service for special cases by special order.

The Agence Nationale des Produits Pharmaceutiques (ANPP), a public institution under the tutelle of the Ministère de l'Industrie Pharmaceutique, issues the homologation decision required to place medical devices on the Algerian market, after opinion of the device homologation commission.

A commission d'homologation des dispositifs médicaux created at ANPP gives its opinion on applications submitted by the ANPP Director General, including renewal, modification, withdrawal, transfer and cession of homologation decisions and any question of quality, safety, innocuity and performance; it includes representatives of the pharmaceutical industry and health ministries and the national pharmacovigilance and materiovigilance centre.

ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), a decentralized autarchic body under the Ministerio de Salud, is the competent authority for medical devices and IVDs nationwide.

Within its competence in the field of circulation of medical devices in Armenia, the authorised body (լիազոր մարմին) — the Ministry of Health — carries out the regulation of circulation, the licensing of the activity types provided for by law, the state registration of medical devices, the certification of imported medical devices, examinations and professional observation through the expert organisation designated by Government decision, and the collection and analysis of information on adverse events (incidents) during the use of medical devices and the adoption of the corresponding decisions. The expert organisation designated by Government decision (Փորձագիտական կազմակերպություն) carries out the examinations and professional observation in the field of state regulation of the circulation of medical devices. The certificate for imported devices is issued on the letterhead of the Ministry of Health and signed by the Ministry's general secretary (Decree No. 429 Ն, Form No. 3). The register of medical devices registered in Armenia is kept by the authorised body.

State control in the field of circulation of medical devices is carried out by the inspection body authorised by the Government to exercise control, in the procedure established by law. Monitoring of the safety, quality and effectiveness of medical devices — the collection of information on adverse effects, events (incidents) and facts endangering human life or health, and the analysis of the data obtained — is carried out by the authorised body (Ministry of Health) through the Expert Organisation.

Therapeutic Goods Administration (TGA), part of the Australian Government Department of Health, Disability and Ageing, is the regulator for medical devices and IVDs under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.

Supplying or importing medical devices not included in the ARTG (absent an exemption) is a criminal offence carrying up to five years imprisonment and/or 5,000 penalty units (one penalty unit valued at AUD 330 under the Crimes Act 1914).

The Federal Office for Safety in Health Care (BASG, Bundesamt für Sicherheit im Gesundheitswesen) is the competent national authority for medical devices and IVDs under Regulations (EU) 2017/745 and 2017/746, the market surveillance authority under Regulation (EU) 2019/1020, and the authority for notified bodies; its annual market surveillance programme is coordinated with and approved by the Federal Ministry for Social Affairs, Health, Care and Consumer Protection (BMSGPK).

State registration of medical devices is granted by the Ministry of Health (Səhiyyə Nazirliyi) of the Republic of Azerbaijan, which enters the device in the state register and thereby authorises its import into, manufacture in, sale in and use in Azerbaijan. The technical expertise on which registration is based is carried out by the Analytical Expertise Center ('Analitik Ekspertiza Mərkəzi'), a public law entity of the Ministry. The state register is maintained by the Ministry through the Center, in electronic form, on the websites of both bodies.

The competent authority for medical devices and IVDs in the Kingdom of Bahrain is the National Health Regulatory Authority (NHRA), established by Law No. (38) of 2009 as amended by Decree Law No. (32) of 2015, acting through its Medical Devices & Supplies Control Section. NHRA licenses medical device authorized representatives and facilities, classifies and registers devices, controls importation at the ports of entry through the OFOQ system, and operates post market surveillance, field safety notice and recall functions. The Supreme Council of Health issues the governing resolutions.

Directorate General of Drug Administration (DGDA, ঔষধ প্রশাসন অধিদপ্তর) under the Ministry of Health and Family Welfare is the regulator for drugs including medical devices; the existing department continues as if established under the Drugs and Cosmetics Act 2023, and its Director General is the Licensing Authority.

Ministry of Health of the Republic of Belarus (Министерство здравоохранения) is the authority that carries out state registration of medical products and issues the registration certificate (регистрационное удостоверение) as its permission.

RUP 'Center for Expertise and Testing in Healthcare' (РУП «Центр экспертиз и испытаний в здравоохранении», rceth.by) organizes the preliminary technical works (expertise, inspection, testing), issues conformity conclusions, and is the operator of the State Register of medical devices.

State institution 'State Pharmaceutical Surveillance' (ГУ «Госфармнадзор») carries out state surveillance over the circulation of medical products in Belarus.

The Federal Agency for Medicines and Health Products (FAMHP / AFMPS) is designated by national law as the competent authority for medical devices within the meaning of Article 101 of Regulation (EU) 2017/745.

FAMHP is also designated as the authority responsible for notified bodies under Article 35 of Regulation (EU) 2017/745 (and Article 31 of Regulation (EU) 2017/746).

statement: AGEMED's statutory functions include issuing prior import authorisations and company opening authorisations, issuing technical procedures, evaluating, authorising, regulating, controlling and inspecting the production, import, storage, distribution, marketing and prices of medicines and health technologies, evaluating their safety, efficacy and quality, issuing marketing authorisations through sanitary registrations, inspecting and auditing manufacturers, importers and wholesalers, and running pharmacovigilance, technovigilance and haemovigilance programmes. · article: Art. 7(c), (d), (e), (f), (g)

statement: AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud) was created by Decreto Supremo N° 2905 of 21 September 2016 on the basis of UNIMED and the CONCAMYT quality control laboratory, and is a public institution decentralised from the Ministry of Health with independence of administrative, financial, legal and technical management. It is responsible for regulating the activities of natural and legal persons in the field of medicines and health technologies, which includes medical devices. · article: Art. 3; Art. 2

The competent authority for medical devices in Bosnia and Herzegovina is the Agency for Medicines and Medical Devices of Bosnia and Herzegovina (Agencija za lijekove i medicinska sredstva Bosne i Hercegovine, ALMBiH), a state level body. Under Article 8 of the Act its device remit comprises keeping the register of medical devices for the territory of BiH, the register of manufacturers of medical devices and the register of legal entities engaged in wholesale distribution; issuing the certificates of entry in those registers; collecting, analysing and responding to undesirable occurrences in the application of medical devices (materiovigilance); participating in conformity assessment and marking of medical devices in BiH against harmonised European standards and the technical regulations made under the Law on Technical Requirements for Products and Conformity Assessment; and professional inspection and supervision of the manufacture and wholesale marketing of medical devices.

The regime is split. Conditions concerning premises, equipment and personnel for the manufacture and retail of medical devices, and pharmaceutical inspection supervision of retail trade in medical devices, are prescribed by the two Entities (Federation of Bosnia and Herzegovina and Republika Srpska) and by Brčko District, not by the state level Agency. The state Act and the Ordinance set the registration, conformity, marking, wholesale and vigilance rules; the Entities and Brčko District set the facility level conditions.

The Botswana Medicines Regulatory Authority (BoMRA) is the national regulatory authority for medical devices. The Medicines and Related Substances Act, 2013 does not create a separate device statute: section 2 defines 'medicine' to include '(g) any medical device', and defines 'medical device' separately, so the Act's registration, import, distribution and post market machinery applies to devices. BoMRA operates a dedicated Medical Devices Unit within the Department of Product Evaluation and Registration.

ANVISA (Agência Nacional de Vigilância Sanitária) is the federal competent authority for medical devices and IVDs: a special regime autonomous body (autarquia sob regime especial) linked to the Ministry of Health.

Medical devices fall within ANVISA's statutory scope via Lei 9.782/1999 Art. 8º §1º VI, which covers medical hospital, dental and hemotherapy equipment and materials and laboratory and imaging diagnostics.

The Brunei Darussalam Medicines Control Authority established by s. 5 of the Medicines Act is the only product regulatory authority created by Brunei statute, and s. 6 confines its functions to registration, licensing and listing of medicinal products and to the import, manufacture, distribution, labelling and disposal of medicinal products. The Act read in full confers no function over medical devices or in vitro diagnostics on the Authority or on any other body.

Under the Radiation Protection Act (Chapter 228) the Minister appoints an Authority charged with the Act's administration, and that Authority licenses the import, possession, use, manufacture and sale of 'controlled apparatus', defined as apparatus that produces ionising radiation when energised or because it contains radioactive material. This is the only statutory authorisation regime in Brunei that captures a class of medical equipment.

Bulgarian Drug Agency (BDA, ИАЛ — Изпълнителна агенция по лекарствата) is the competent authority for medical devices and IVDs in Bulgaria: it carries out registration under Chapter Two of the Law on Medical Devices (ЗМИ), issues clinical investigation and wholesale trade permits, conducts market surveillance and maintains the national vigilance system.

Market surveillance on the territory of the Republic of Bulgaria is carried out by ИАЛ (Bulgarian Drug Agency) through inspectors and experts.

Health Canada (Health Products and Food Branch) is the federal regulator of medical devices; device licences are administered by the Medical Devices Directorate.

The Instituto de Salud Pública de Chile (ISP) is the competent authority for medical devices and IVDs ('elementos de uso médico'): it authorizes and supervises the control/certification of quality for these products. Device regulation is implemented by ISP's Departamento Agencia Nacional de Dispositivos Médicos, Innovación y Desarrollo (ANDIM).

The National Medical Products Administration (NMPA, 国务院药品监督管理部门) is responsible for supervision and administration of medical devices nationwide.

Device regulation is exercised at three administrative levels: NMPA (national), provincial drug regulatory departments, and municipal (prefecture level, 设区的市级) departments. For example, domestic Class I product filing is submitted to the municipal level department.

INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) is the national authority that issues the registro sanitario for medical devices and the permiso de comercialización for controlled technology biomedical equipment, and carries out sanitary surveillance.

INVIMA acts as the national sanitary reference institution and executes the policies of the Ministerio de Salud y Protección Social; its Dirección de Dispositivos Médicos y Otras Tecnologías is in charge of device oversight. Decreto 4725/2005 was issued under Ley 09/1979 Art. 564, Ley 100/1993 Art. 245 and Ley 715/2001 Art. 42.3.

The Ministerio de Salud de Costa Rica is the national regulatory authority (Autoridad Reguladora Nacional) responsible for the regulation, registration and control of medical devices (equipo y material biomédico, EMB). Registration processing sits with the Dirección de Regulación de Productos de Interés Sanitario.

The Centro Nacional de Tecnovigilancia (CNTV), seated in the corresponding Ministerio de Salud organizational unit, coordinates the National Tecnovigilance System and receives adverse event reports for medical devices.

Device marketing authorisations in Côte d'Ivoire are issued by the Autorité Ivoirienne de Régulation Pharmaceutique (AIRP). The AIRP acts as the 'autorité de réglementation pharmaceutique' to which UEMOA Décision n° 03/2022/CM/UEMOA assigns the delivery of device marketing authorisations and/or putting into service authorisations in each member state; the AIRP's own device procedure is issued under that decision and is signed by its Directeur Général. Applications are addressed to the Directeur Général of the AIRP, and the AIRP also agrees the Ivorian import and commercialisation companies that may apply on a manufacturer's behalf.

Croatia has two competent authorities for MDR/IVDR: the ministry responsible for health (Ministarstvo zdravstva) and the Agency for Medicinal Products and Medical Devices (Agencija za lijekove i medicinske proizvode, HALMED). The Ministry approves clinical investigations and performance studies, designates and notifies conformity assessment bodies, monitors notified bodies, gives consent to Agency derogation approvals and carries out supervision; the Agency verifies the data entered in the electronic registration system of economic operators and assigns the unique registration number, decides classification disputes between manufacturers and notified bodies, keeps the distributor register, approves national derogations, issues free sale certificates, conducts device vigilance and may request additional information from health institutions.

The binding base regime is the Reglamento para la Evaluación y el Control Estatal de Equipos Médicos, approved by MINSAP Resolución No. 184 of 2008, published in Gaceta Oficial No. 64 Ordinaria de 2008 (norm identifier GOC 2008 1472 O64). It derogated Resolución 110 de 1992 and Resolución 165 de 1997 of MINSAP.

CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos) is the national regulatory authority for medical devices/equipment and IVDs (diagnosticadores). It was created by MINSAP Resolución No. 153 of 27 June 2011 (fusion of BRPS, CECM and CCEEM under Ministerio de Economía y Planificación Resolución 263/2011) and operates under the mission and functions approved by MINSAP Resolución No. 165 of 14 April 2014, subordinate to the Ministry of Public Health.

Decreto No. 133/2025 of the Council of Ministers, Reglamento de la Ley 165 'Ley de la Salud Pública', was published in Gaceta Oficial GOC 2026 123 O9 of 23/12/2025, enters into force 90 days after publication, and derogates Decreto 139 of 4 February 1988 (the previous Reglamento of the health law).

CYMDA is the designating and supervising authority for the notified bodies established in the Republic of Cyprus, and is responsible for enforcing the requirements of Regulations (EU) 2017/745 and 2017/746 in respect of those notified bodies.

The competent Cypriot government authority for medical devices and in vitro diagnostic medical devices is the Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού — the Cyprus Medical Devices Authority (CYMDA) — a unit of the Department of Medical Services and Public Health Services (Ιατρικές Υπηρεσίες και Υπηρεσίες Δημόσιας Υγείας) of the Ministry of Health, seated at Prodromou 1 & Cheilonos 17, 1449 Agios Andreas, Nicosia, and reachable at cymda@mphs.moh.gov.cy. It is a distinct body from the Ministry of Health's Pharmaceutical Services, which handles medicines. CYMDA describes itself as the competent government authority responsible for ensuring that medical devices comply with Cypriot and European legislation.

CYMDA is the regulatory authority for market surveillance of medical devices under Cypriot legislation, charged with inspecting manufacturers, importers and distributors and their products and taking the appropriate action where non compliant products are found. In that role it is a member of the European market surveillance group, through which national competent authorities notify each other of actions taken on non compliant products, and it exchanges information and data through the vigilance system.

State Institute for Drug Control (SÚKL) is the competent authority for medical devices and IVDs: it supervises persons handling devices, imposes fines by decision, authorises clinical investigations, registers manufacturers, authorised representatives, importers and distributors, and decides whether a product is a device and its classification.

State administration in the devices area is exercised by the Ministry of Health (Ministerstvo zdravotnictví), the State Institute for Drug Control (SÚKL, 'Ústav'), and the Czech Office for Standards, Metrology and Testing (ÚNMZ, 'Úřad pro technickou normalizaci, metrologii a státní zkušebnictví').

SÚKL exercises all competences that MDR/IVDR or directly applicable EU acts assign to a Member State or its authority, except notified body matters under MDR Art. 35 58 / IVDR Art. 31 53, which belong to ÚNMZ under separate legislation. SÚKL also issues free sale certificates (§ 5(2)(j)) and decides on offences in the first instance (§ 5(2)(k)).

DKMA's delineation guidance assigns borderline product categories to other authorities: medicines (incl. herbal and homeopathic products) to DKMA, food supplements to the Danish Veterinary and Food Administration (Fødevarestyrelsen), cosmetics and biocides to the Environmental Protection Agency (Miljøstyrelsen), and laboratory equipment and PPE to the Danish Safety Technology Authority (Sikkerhedsstyrelsen). Annex XVI products without a medical purpose fall under the device rules.

The Danish Medicines Agency (Lægemiddelstyrelsen) is the competent authority for medical devices in Denmark, responsible for notified bodies ('bemyndigede organer') and for authorisation, monitoring, supervision and control under the national act, national regulations and EU device law.

The Danish Medicines Agency may control manufacturers and their authorised representatives, distributors, importers, notified bodies and clinical investigation/performance study sponsors; it may issue injunctions and prohibitions (including ordering sample devices and all documents needed for control), and its inspectors have access without a court order to production, business, storage and trial site premises.

statement: The Dirección General de Medicamentos, Alimentos y Productos Sanitarios (DIGEMAPS) is the regulatory authority for medicines, food and sanitary products (including medical devices), created by Decreto núm. 82 15 of 6 April 2015 under the dependency of the Ministerio de Salud Pública y Asistencia Social, and it also amended article 81 of the medicines regulation Decreto 246 06. Registration is handled by DIGEMAPS' Dirección de Registro Sanitario and post market matters by its Dirección de Vigilancia Sanitaria; service requests are received through the MSP Ventanilla Única de Servicios. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 'Doctor Leopoldo Izquieta Pérez') is the entidad competente of the National Health Authority that grants, suspends, cancels and re registers sanitary registrations of medical devices; the Ministerio de Salud Pública holds the rectoría of the health system under the Ley Orgánica de Salud. ARCSA was created by Decreto Ejecutivo 1290 (R.O. S 788, 13 Sep 2012, reformed by Decreto 544, R.O. 428, 30 Jan 2015), whose Art. 10 empowers it to issue technical sanitary norms.

Egyptian Drug Authority (EDA) is the competent authority for medical devices; its Central Administration of Medical Devices (CAMD) runs registration, import approvals and device safety.

The Central Administration of Medical Devices (CAMD) of EDA houses the General Administration of Registration of Medical Devices and the market authorization administration handling device registration, variations and import approvals.

Ravimiamet (State Agency of Medicines) performs the tasks and issues the administrative acts of the competent authority, and of the authority responsible for notified bodies, laid down in the Estonian Medical Devices Act and in Regulations (EU) 2017/745 and (EU) 2017/746, unless those regulations provide otherwise.

Ravimiamet carries out state and administrative supervision over compliance with the Medical Devices Act, the legislation established under it and Regulations (EU) 2017/745 and 2017/746; supervision of the requirements of Chapter 3 (professional use of devices in the provision of health services) is carried out by Terviseamet (Health Board).

The Ethiopian Food and Drug Authority (EFDA) is mandated to safeguard the health and safety of patients and users by assessing the quality, safety and effectiveness of medical devices prior to registration and marketing authorization. Article 20(1) of the Food and Medicines Proclamation No. 1112/2019 requires any medical device manufactured, imported, exported, stored, distributed, transported, sold, held, used or transferred in Ethiopia to be registered and granted marketing authorization. Device registration is administered by the Medical Device Evaluation and Market Authorization Lead Executive Office through the Electronic Regulatory Information System (eRIS).

In vitro diagnostic medical devices in the EU are governed by Regulation (EU) 2017/746 (IVDR), which applies from 26 May 2022.

Medical devices in the EU single market are governed by Regulation (EU) 2017/745 (MDR), which applies from 26 May 2021 (date deferred from 26 May 2020 by Regulation (EU) 2020/561).

There is no single EU wide approval authority: Member States may only designate as notified bodies the conformity assessment bodies that completed the Article 39 assessment and comply with Annex VII MDR; notified bodies then carry out conformity assessment. Market surveillance lies with national competent authorities.

Fimea (Finnish Medicines Agency, Lääkealan turvallisuus ja kehittämiskeskus) holds general steering and supervision of medical device activities in Finland; it is the competent authority under MDR and IVDR, the authority responsible for notified bodies, and the market surveillance authority for devices under Regulation (EU) 2019/1020.

STUK (Radiation and Nuclear Safety Authority, Säteilyturvakeskus) supervises compliance with Radiation Act requirements on population exposure to non ionizing radiation in medical devices; Fimea remains the general device authority.

ANSM (Agence nationale de sécurité du médicament et des produits de santé) is the competent authority for implementing Regulation (EU) 2017/745 in France and the responsible authority for notified bodies under Article 35 of that Regulation.

The administrative authority in charge of competition and consumer affairs (DGCCRF, per Art. L522 1 Code de la consommation) also acts as competent authority for post market control and market surveillance of devices intended to be used directly by consumers or by professional users other than health professionals in consumer facing services.

The medical device authority in Georgia is the LEPL Regulation Agency for Medical and Pharmaceutical Activities (სამედიცინო და ფარმაცევტული საქმიანობის რეგულირების სააგენტო), a public law legal entity under the state control of the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs. Under the medical device technical regulation the Agency registers clinical investigations of medical devices, issues the clinical investigation registration certificate and takes the connected decisions; under the Law on Medicines the Agency grants, refuses, suspends and revokes marketing authorisations, formalises the marketing authorisation document and keeps the Departmental Registry.

Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) is the competent higher federal authority (Bundesoberbehörde) for medical devices and, by default, for IVDs under the MPDG, unless the law assigns competence to the Paul Ehrlich Institut.

The Paul Ehrlich Institut (PEI), not BfArM, is competent for IVD tasks under the MPDG where the device falls under IVDR Annex VIII rules 1, 2 and 3(a) to (e) and (g), and for companion diagnostics (therapiebegleitende Diagnostika) tied to medicinal products within PEI's AMG remit.

The authorities of the German Länder (federal states) are the competent authorities for the purposes of MDR, IVDR and the MPDG (market surveillance/Überwachung), unless the MPDG provides otherwise.

The ZLG (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten), the joint body of the 16 Länder, exercises the Länder's tasks of recognising, designating and monitoring certification bodies and testing laboratories for medical devices (Benennung/Anerkennung/Überwachung).

The Food and Drugs Authority (FDA) Ghana is the competent authority for medical devices; the Medical Devices Department processes and grants market authorisation for medical devices intended for export and/or sale in Ghana.

The Medical Devices Department maintains the medical devices register, issues and revokes registration certificates, registers importers of medical devices, and has separate Low Risk and High Risk Medical Devices Units.

A person who contravenes Act 851 ss.111 124 (including unregistered sale and import of devices) is liable on summary conviction to a fine of not less than 7,500 and not more than 15,000 penalty units, or imprisonment of 15 to 25 years, or both.

EOF (National Organization for Medicines, Εθνικός Οργανισμός Φαρμάκων) is the national competent authority for medical devices and IVDs and the authority for the application of Regulations (EU) 2017/745 and 2017/746, designated by ΚΥΑ Α4γ/Γ.Π.οικ.88159/2017 (ΦΕΚ Β' 4234/2017).

Within EOF: Τμήμα Αξιολόγησης Υγειονομικού Υλικού (Διεύθυνση Αξιολόγησης Προϊόντων) handles registration/notification; Τμήμα Κλινικών Δοκιμών handles clinical investigations; Τμήμα Ανεπιθύμητων Ενεργειών (Δ/νση Φαρμακευτικών Μελετών) handles materiovigilance; Τμήμα Ελέγχου Κυκλοφορίας (Δ/νση Ελέγχου Παραγωγής & Κυκλοφορίας Προϊόντων) handles market surveillance and corrective actions.

The competent authority for the sanitary control of medicines and related products, which by law include medical devices and diagnostic reagents, is the Ministerio de Salud Pública y Asistencia Social (MSPAS), acting through the Dirección General de Regulación, Vigilancia y Control de la Salud and, within it, the Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA).

The Medical Device Division (MDD) of the Department of Health manages the Medical Device Administrative Control System (MDACS).

Listing under MDACS is voluntary; there is no statutory requirement to list a medical device before placing it on the Hong Kong market.

NNGYK (Nemzeti Népegészségügyi és Gyógyszerészeti Központ, National Center for Public Health and Pharmacy), through its Medical Device Department (Orvostechnikai Főosztály, site still branded OGYÉI), is the competent authority for medical devices and IVDs. Duties include market surveillance, NOR registration, EUDAMED data entry, clinical investigation authorization, incident reporting oversight and free sale certificate (FSC) issuance.

Lyfjastofnun (Icelandic Medicines Agency, IMA) is the Icelandic competent authority under Article 101 of Regulation (EU) 2017/745 (MDR) and Article 96 of Regulation (EU) 2017/746 (IVDR). Its statutory functions are to implement the Regulations and the Medical Devices Act, to supervise medical devices, and to open cases and take decisions on its own initiative or on a report or tip off.

Lyfjastofnun supervises compliance with the Medical Devices Act and the Regulations, opens cases on its own initiative or on a report concerning device safety, performs market surveillance in accordance with Section 3 of Chapter VII of the Regulations, decides whether a report gives sufficient grounds for investigation, and may rank cases by priority. It may process personal data, including sensitive data on whether a person has received an implant, for supervision purposes.

Designation of notified bodies in Iceland is split. The accreditation division of Hugverkastofa (Icelandic Intellectual Property Office) assesses the competence of an applicant and, having obtained the opinion of Lyfjastofnun, designates notified bodies to Lyfjastofnun. Lyfjastofnun then notifies them to the EFTA Surveillance Authority, the European Commission and the other EEA States under Chapter IV of the Regulations.

CDSCO is the Central Licensing Authority (CLA) for import of all device classes, manufacture of Class C and Class D, clinical investigation of investigational devices, and clinical performance evaluation of new IVDs; State Drugs Controllers are State Licensing Authorities for manufacture of Class A/B and for sale of all classes.

The Minister of Health (Menteri Kesehatan) of the Republic of Indonesia is the authority for medical devices and household health supplies (PKRT); the responsible unit is the Director General for pharmaceutical and medical device affairs (Direktur Jenderal Kefarmasian dan Alat Kesehatan).

Under PMK 5/2026, safety/quality control of devices (Alat Kesehatan) and PKRT is performed by the Minister of Health, while control of Sediaan Farmasi and PKMK is performed according to regulations of the head of the non ministerial government agency for food and drug supervision (BPOM).

Iran Food and Drug Administration (سازمان غذا و دارو, IFDA) regulates medical devices; the national operating unit is its General Directorate of Medical Equipment and Supplies (اداره کل تجهیزات و ملزومات پزشکی), known as IMED, which licenses and supervises manufacture, import, distribution and after sales activities.

The Iran FDA (سازمان غذا و دارو) operates under the Ministry of Health and Medical Education (وزارت بهداشت، درمان و آموزش پزشکی); the ministry and FDA identities are displayed together on the FDA's TTAC system.

IFDA delegates execution to the food and drug deputies of medical sciences universities: risk class A/B manufacturing licenses are issued and renewed by university deputies (e.g., Isfahan UMS), and review/issuance of IRC codes for such items is delegated to selected universities.

Federal Iraq: Ministry of Health (MOH); its Technical Affairs Directorate (دائرة الأمور الفنية) houses the Registration Department (قسم التسجيل — companies, preparations, scientific offices) and the Medical Devices Management Department; KIMADIA, the MOH state company for marketing drugs and medical appliances, executes public sector import of devices. The Kurdistan Region runs a separate KRG MOH structure (KMCA).

The Central Organization for Standardization and Quality Control (COSQC, الجهاز المركزي للتقييس والسيطرة النوعية), established by Law No. 54 of 1979 (amended), is Iraq's central body for measurement standards, calibration references and Iraqi quality standards, under the Ministry of Planning; it inspects imported goods and monitors the quality of local products.

The Medical Devices Management Department (قسم إدارة الأجهزة الطبية) within MOH Technical Affairs Directorate provides technical specifications and consulting and follows up medical devices across the ministry — including follow up with health directorates on installation, warranty and maintenance, maintaining a detailed statistical database of devices, and testing/evaluating device performance and their need for calibration and periodic maintenance. Market registration of devices is not among its listed duties.

KIMADIA (State Company for Marketing Drugs and Medical Appliances, founded 1964) is the MOH public company whose functions include taking the necessary measures to import and market Iraq's needs of medicines, scientific appliances, medical and service devices and their spare parts; it is the operational public procurement import channel for devices.

In the Kurdistan Region of Iraq, import licenses for medical devices and materials are issued by the Directorate of Drug and Medical Device Import and Production (KMCA, Erbil) under the KRG Ministry of Health — a structure separate from the federal MOH.

The Health Products Regulatory Authority (HPRA) is Ireland's competent authority for medical devices: S.I. No. 261 of 2021 defines 'Authority' as the HPRA and assigns it the State functions under the listed MDR articles (including Articles 42, 70 78, 95, 96, 98, 100, 102, 106, 109 and 110).

The Medical Devices Regulations 2021 and the MDR provisions they refer to are enforced by HPRA.

HPRA is designated as the market surveillance authority for medical devices for the purposes of Regulation (EC) No 765/2008 and the Market Surveillance Regulation (EU) 2019/1020.

The Medical Device Division — AMAR (אגף ציוד רפואי אמ"ר) of the Israel Ministry of Health — is the competent authority. It registers medical devices in Israel, issues various types of import permits, monitors marketing, issues export supporting documents, and operates a registration, supervision and control mechanism over manufacture, import and marketing of medical devices.

The Ministry of Health (Ministero della salute) is designated competent authority for medical devices under MDR Art. 101; every MDR reference to the Member State competent authority means the Ministry of Health. It is also the authority responsible for notified bodies established in Italy (Art. 3(2)).

Where the MDR refers to the national competent authority for medicinal products, this means AIFA (Italian Medicines Agency). The Ministry of Economic Development (now MIMIT) remains the national contact point of the NANDO information system and competent for non MDR marketing aspects; AGCM remains competent for unfair commercial practices under the Consumer Code.

MHLW (Minister of Health, Labour and Welfare) grants device/IVD marketing approval (承認, Art. 23 2 5(1)); PMDA (機構) conducts the approval review and QMS conformity surveys on MHLW's behalf (Art. 23 2 7(1)); registered certification bodies (登録認証機関) certify MHLW designated products (Art. 23 2 23(1)).

Jordan Food and Drug Administration (JFDA) — Medical Devices and Supplies Directorate is the competent authority that registers and monitors imported and locally manufactured medical devices and supplies under the 2019 Basis for import and circulation of medical supplies (which covers sterilants and disinfectants).

The JFDA Director General forms committees to execute the Law, including a Devices and Medical Supplies Committee that also covers sterilants and disinfectants.

The Higher Committee for Drug and Pharmacy sets the basis and criteria (الأسس والمعايير) for matters including circulation of medical supplies and adoption of manufacturing sites for Article 3(b) materials.

The Higher Committee for Drug and Pharmacy (اللجنة العليا للدواء والصيدلة), chaired by the JFDA Director General, is the top committee under the Drug and Pharmacy Law; the director of the Medical Devices and Supplies Directorate is a standing member.

The Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan (Комитет медицинского и фармацевтического контроля МЗ РК, KMFk) is the state body for circulation of medicines and medical devices: it carries out state registration, re registration and dossier amendments, withdrawal of registration decisions, and keeps the State Register of medicines and medical devices.

Expertise of medicines and medical devices is a state monopoly carried out by the state expert organization in the sphere of circulation of medicines and medical devices (RGP «National Center for Expertise of Medicines and Medical Devices» of the Committee).

The Pharmacy and Poisons Board (PPB) is the national regulator for medical devices and IVDs in Kenya, established under section 3 of the Pharmacy and Poisons Act (Cap. 244); section 3B(1) makes the Board responsible for the regulation of health products and technologies and the profession of pharmacy.

The instrument that carries Kuwait's medical device registration framework — Ministerial Decree No. 387 of 2025 — was issued by the Kuwait Ministry of Health (وزارة الصحة) and published in the Official Gazette under the Decisions category. The Ministry is accordingly the rule making authority for device registration; its subordinate registration and control administration is the body that receives applications.

statement: The Health Inspectorate (Veselības inspekcija) acts as the market surveillance authority for medical devices under the Product and Service Safety Law, the Conformity Assessment Law and Regulation (EU) 2017/745. It controls the operation of devices and carries out inspections at manufacturing sites, retail outlets, and at importers, distributors and authorised representatives. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

statement: The medical device competent authority in Latvia is the State Agency of Medicines (Zāļu valsts aģentūra, ZVA). Its device functions are to register medical devices manufactured in Latvia, to issue authorisations for placing specially supplied medical devices on the market, to carry out medical device vigilance, and to issue authorisations for clinical investigations of medical devices. The agency maintains the LATMED device register and runs the notification procedure. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

A health technology unit is established at the Ministry of Public Health to carry out all executive tasks for the evaluation and surveillance of medical technologies including implantable medical devices. Pending its creation, a commission composed of staff in charge of the pharmacy departments (import/export service) and sanitary engineering at the MOPH is responsible for executing the terms of the procedure. The unit's tasks include evaluating medical technologies, adopting national standards for placing devices on the market, deploying supplier and device registration procedures, and setting up and following the post market surveillance system.

The Amt für Gesundheit (Office of Public Health) is the competent authority of Liechtenstein for implementing Regulation (EU) 2017/745 (MDR) and the national EWR MepV; EWR IvDV Art. 17(1) assigns it the same role for Regulation (EU) 2017/746 (IVDR).

Liechtenstein operates a dual regime: EEA law (MDR/IVDR via EWR MepV/EWR IvDV) governs the EEA channel, while Swiss therapeutics legislation (HMG, Medizinprodukteverordnung/MepV SR 812.213, IvDV SR 812.219) has applied in Liechtenstein under the customs treaty since 1 January 2002. The Amt für Gesundheit and Swissmedic cooperate under the administrative agreement of 27 February 2024 (LGBl 2024 Nr. 74); each authority enforces in its own territory and measures apply across the customs territory.

The Amt für Volkswirtschaft (Office of Economic Affairs) is the Liechtenstein authority responsible for notified bodies under MDR Art. 35; EWR IvDV Art. 17(3) assigns it the same role under IVDR Art. 31. Designation fees are charged under EWR MepV/EWR IvDV fee schedules.

The Amt für Gesundheit is tasked in particular with: registration of manufacturers, authorised representatives and importers under MDR Art. 31; issuing exceptional authorisations for non compliant devices under MDR Art. 59; receiving and processing vigilance reports under MDR Arts. 87 90; and market surveillance under MDR Arts. 93 99. EWR IvDV Art. 17(2) lists the parallel IVD tasks (IVDR Arts. 28, 54, 82 85, 88 94).

VASPVT designates testing laboratories and certification/control bodies wishing to become notified bodies for medical device conformity assessment, supervises them, extends/renews their scope of activities, and suspends/withdraws their designations.

VASPVT registers medical devices placed on the market, issues permits entitling persons to perform technical condition inspection of medical devices, and issues free sale certificates.

The State Health Care Accreditation Service under the Ministry of Health (Valstybinė akreditavimo sveikatos priežiūros veiklai tarnyba prie Sveikatos apsaugos ministerijos, VASPVT; known as VASPMT before its renaming) is the authority empowered by the Minister of Health to implement the national medical device regime, acting as the competent authority responsible for implementing Regulation (EU) 2017/745.

Ministry of Health and Social Security — Directorate of Health (Direction de la santé); its Division de la pharmacie et des médicaments (DPM) acts as the national competent authority for medical devices and IVDs.

The Pharmaceutical Administration Bureau (ISAF, 藥物監督管理局) is the competent authority: it assembles registration and business licence dossiers and archives filing materials; the ISAF President decides on registration.

Medical Device Authority (MDA, Pihak Berkuasa Peranti Perubatan), established under the Medical Device Authority Act 2012 [Act 738], is the competent authority implementing the Medical Device Act 2012 [Act 737] under the Ministry of Health Malaysia.

The Minister of Health makes regulations and orders under section 79(2) of Act 737, designates devices by order, and determines appeals against Authority decisions; the Minister's appeal decision is final and binding.

The national competent authority for medical devices is the Medicines Authority established under article 4 of the Medicines Act (Cap. 458), designated by S.L. 458.59 as the authority in charge of regulating and ensuring compliance with the local and international laws applying to medical devices, and as the authority responsible for the designation and supervision of notified bodies concerned with medical devices in Malta. Its device work sits in the Medical Devices, Pharmaceutical Collaboration and Entrepreneurship Directorate, which processes national registrations and notifications, carries out market surveillance and post market vigilance, designates and oversees notified bodies registered in Malta, and authorises clinical investigations and performance studies.

COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the decentralized organ of the Secretaría de Salud, exercises federal regulation, control, surveillance and health promotion powers over health supplies (insumos para la salud), including medical devices; sanitary registrations are granted by the Secretaría de Salud through COFEPRIS. It also coordinates pharmacovigilance and tecnovigilance through its Centro Nacional de Farmacovigilancia y Tecnovigilancia (fraction XII Quinquies, added DOF 15 01 2026).

The competent authority that carries out the notification and registration of medical devices is the Agency for Medicines and Medical Devices (Agenția Medicamentului și Dispozitivelor Medicale, AMDM). AMDM is an administrative authority with regulatory and supervisory competences in the fields of medicines, pharmaceutical activity and medical devices, seated in Chișinău. Within AMDM the competent directorate for medical devices is the Direcția Dispozitive Medicale, whose basic attributions include coordinating device regulations, tracking that revisions respect European norms and international standards, and evaluating and/or auditing, on request, the natural or legal persons that apply for registration of medical devices.

AMDM keeps the State Register of Medical Devices (Registrul de stat al dispozitivelor medicale, RSDM) under art. 17 alin. (1) of Legea nr. 102/2017 and Legea nr. 71/2007 on registers. Registration consists of entry of the device data in the RSDM and the assigned identification number is published in the register, which is publicly searchable. The register is the record of devices placed on the Moldovan market, of manufacturers and of the persons responsible for placing devices on the market.

AMDM's Direcția Dispozitive Medicale has, among its basic attributions, that it evaluates and/or audits, on request, the natural or legal persons that apply for registration of medical devices, and that it coordinates device regulations and normative acts while ensuring that revisions respect European norms and international standards. Its page also lists as its field of activity device registration, market surveillance and harmonised standards.

The Agency's own site describes it as a Government implementing agency and publishes its management structure, which includes a Medical Equipment Division (Эмнэлгийн тоног төхөөрөмжийн газар) alongside the Administration and Management Division, the Licensing and Permits Regulatory Division, the Pharmacovigilance Surveillance and Research Division, the Medicines Supply Division, the Quality Control Division, the Medicines Registration Department, the Medicines Manufacturing Department and the Medicines Testing Laboratory. The Agency's published contact details are an Ulaanbaatar address in Chingeltei district, telephone +(976) 51 260182, and the abbreviation ЭЭХХЗГ.

The Law establishes that a Pharmaceutical Council and a Medical Devices Council operate respectively at the central administrative body in charge of health. The Medical Devices Council is a non staff professional council whose chair and secretary are appointed directly, whose members are selected for three year terms, and which is appointed by the Government member in charge of health; it has a composition of 13 to 15 people with a non voting secretary. Device registration and listing decisions rest on the Council's decision.

Medical devices are regulated by the Эм, эмнэлгийн хэрэгслийн хяналт, зохицуулалтын газар (Medicines and Medical Devices Control and Regulatory Agency, abbreviated ЭЭХХЗГ), a Government implementing agency (Засгийн газрын хэрэгжүүлэгч агентлаг) within the portfolio of the Minister of Health, established by Government Resolution No. 222 of 16 December 2020 with a maximum headcount of 132 and operations commencing 1 January 2021. It is not the Ministry of Health itself; the Ministry sets policy and adopts registration procedures, the Agency administers registration, listing, licensing and surveillance. Device registration is decided by the Medical Devices Council (Эмнэлгийн хэрэгслийн зөвлөл) seated at the health ministry, with the Agency as its working office.

statement: The competent authority for medical devices is the Institute for Medicines and Medical Devices of Montenegro — CInMED (Institut za ljekove i medicinska sredstva Crne Gore). It keeps the registers of manufacturers, wholesalers, importers, specialised retail outlets and medical devices; authorises imports of unregistered devices; authorises and controls clinical investigations; operates the vigilance system; and decides on classification. These tasks are performed as tasks under delegated (transferred) jurisdiction. The Ministry of Health adopts the implementing regulations and designates/authorises conformity assessment bodies; the inspection affairs administration carries out inspection surveillance. · authorityName: Institut za ljekove i medicinska sredstva Crne Gore (CInMED) · authorityNameEn: Institute for Medicines and Medical Devices of Montenegro · authorityType: agency under delegated jurisdiction

Medical devices are 'produits de santé' for the purposes of loi 10 22, which expressly includes 'les dispositifs médicaux au sens de la loi n° 84 12'. The Agence Marocaine du Médicament et des Produits de Santé (AMMPS), a public establishment under the Ministry of Health and Social Protection, is charged with the device competences: receiving the declarations of establishments that manufacture, import, export, distribute or maintain medical devices; setting the framework for device prices and receiving their declared sale prices; supervising inspection of those establishments; and vigilance in the field of medicines and health products. Under loi 84 12 art. 12 the registration certificate itself is issued by 'l'administration', which décret 2 14 607 art. 24 defines as the Minister of Health.

The registration certificate for a medical device is delivered by the administration after consultation of the 'commission nationale consultative des dispositifs médicaux'; the same commission is consulted before the administration orders a cessation of distribution or a recall, and before a definitive withdrawal from the market.

Department of Food and Drug Administration (DFDA, Myanmar FDA) under the Ministry of Health is the competent authority for medical devices.

A dedicated Medical Device Section within DFDA administers medical device pre market control (manufacturing licences, product registration, import recommendation/notification certificates) and post market surveillance.

The Minister of Health, Welfare and Sport (VWS) is the national responsible authority for notified bodies (including designation, suspension and withdrawal) and appoints the competent authorities under the MDR/IVDR; the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) supervises compliance and market surveillance; CIBG/Farmatec (VWS executive agency) operates the national notification, custom made registration, export certificate and exemption desks.

The inspectors of the Health and Youth Care Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ) are charged with supervising compliance with the Wet medische hulpmiddelen and the obligations set under it in the Netherlands.

Medsafe (New Zealand Medicines and Medical Devices Safety Authority) is the regulator that administers medical device regulation under the Medicines Act 1981 and the Medicines Regulations 1984, including the Medicines (Database of Medical Devices) Regulations 2003; the legislation is administered by the Ministry of Health.

The Therapeutic Products Act 2023 was repealed by section 3 of the Therapeutic Products Act Repeal Act 2024, which came into force on 18 December 2024 (day after 17 December 2024 assent); the Repeal Act itself self repealed on the close of 14 January 2025, leaving the Medicines Act 1981 device regime in force.

NAFDAC (National Agency for Food and Drug Administration and Control) controls medical devices, IVDs and related products: no device may be manufactured, imported, exported, advertised, sold, distributed or used in Nigeria unless registered with NAFDAC under the NAFDAC Act CAP N1 (LFN) 2004.

The competent authority for medical devices in North Macedonia is the Agency for Medicines and Medical Devices (Агенција за лекови и медицински средства), established by Article 3 of the Law on Medicines and Medical Devices as an independent state administration organ with the status of a legal person, seated in Skopje.

The full national name is Агенција за лекови и медицински средства; the name used in international legal traffic is 'Macedonian Agency for Medicines and Medical Devices'; the official abbreviation is МАЛМЕД. Filings and correspondence should use MALMED / МАЛМЕД.

Supervision over the implementation of the Law is exercised by MALMED; inspection is carried out by MALMED through pharmaceutical inspectors. At import, inspection is carried out by customs officers together with pharmaceutical inspectors. Wholesalers whose total turnover exceeded 10,000,000 denars in the previous year are subject to a compulsory joint control each year by at least two pharmaceutical inspectors, two tax inspectors and one customs officer.

Direktoratet for medisinske produkter (English: Norwegian Medical Products Agency, NoMA/DMP; website dmp.no; formerly Statens legemiddelverk) is the competent authority for medical devices and IVDs in Norway and supervises economic operators and notified bodies.

A separate national regulation on handling of medical devices (Forskrift om håndtering av medisinsk utstyr, FOR 2013 11 29 1373) binds the health and care service (and other entities handling electromedical equipment) to keep devices safe, correctly maintained and properly used.

Wilful or negligent breach of the national regulation's provisions (including listed MDR/IVDR articles) is punishable by fines or imprisonment; aggravated violations carry up to 2 years' imprisonment. The Directorate may also impose infringement fines (overtredelsesgebyr).

Reprocessing of single use medical devices is not permitted in Norway: Norway did not open the MDR Article 17 option in national law, following a 2021 public consultation assessment by DMP.

Drug Safety Center (DSC), Ministry of Health, regulates medicines, medical devices and supplies in Oman; its Medical Devices Control Department has four sections: Medical Device Registration, Surgical Instruments Registration, In Vitro Diagnostic Devices Registration, and Medical Device Vigilance.

The Drug Regulatory Authority of Pakistan (DRAP) administers medical device regulation through its Medical Devices and Medicated Cosmetics (MDMC) Division; the Medical Device Board (MDB) is responsible for enlistment and registration of medical devices, licensing of establishments, and issuance of import and export permits for medical devices, their components and raw materials.

The Ministry of Health (Ministerio de Salud, MINSA) is the competent authority for regulating medical devices and related products, including infractions and sanctions; it exercises this through the Dirección Nacional de Dispositivos Médicos (DNDM), created within MINSA's structure.

DNDM's functions include issuing the Registro Sanitario, the special import permit (permiso especial de importación) for devices, certifying the Licencia de Operación and the Good Manufacturing/Distribution/Storage Practice certificates, and running a national device vigilance network (Red Nacional de Vigilancia de Dispositivos Médicos).

DINAVISA is a legal person under public law with administrative autonomy, autarquía and its own patrimony, governed by Ley N° 6788/2021 and its regulations, and relates to the Executive branch through the MSPBS. It has full legal capacity to act in the public and private sphere throughout Paraguay.

DINAVISA (Dirección Nacional de Vigilancia Sanitaria) is the authority responsible for the regulation, control and inspection of products for health, expressly including medical devices, executing the public policies designed by the Ministerio de Salud Pública y Bienestar Social (MSPBS), which acts as rector ministry. It may sanction the infringements it detects.

DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), a line organ of the Ministry of Health, is the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) and is in charge nationwide of granting, renewing, amending, denying, suspending or cancelling the registro sanitario for medical devices.

Device registration decisions are formalized in a Resolución Directoral issued by the Dirección de Dispositivos Médicos y Productos Sanitarios of DIGEMID.

Under Ley 29459, the Autoridad Nacional de Salud (ANS) is the Ministry of Health, and the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) is DIGEMID; regional health authorities (ARS/ARM) and the ANM's decentralized organs share enforcement.

FDA Philippines (Food and Drug Administration, Department of Health); the Center for Device Regulation, Radiation Health and Research (CDRRHR) is the regulatory office in charge of regulating medical devices.

RA 3720 (Food, Drug, Device and Cosmetic Act) as amended by RA 9711 (FDA Act of 2009). BFAD was renamed FDA; CDRRHR is one of four regulatory centers and regulates manufacture, importation, exportation, distribution, sale, transfer, promotion, advertisement and sponsorship of health products.

President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Prezes URPL) is the Polish competent authority for medical devices and IVDs (MDR Art. 101 / IVDR Art. 96), the notifying authority for conformity assessment bodies (MDR Art. 35(1)), the market surveillance authority under Regulation (EU) 2019/1020, and the authority issuing scientific opinions on ancillary medicinal substances. The National Centre for Tissue and Cell Banking issues opinions on human tissue aspects.

INFARMED — Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. is the national competent authority for Regulation (EU) 2017/745 and the authority responsible for notified bodies in Portugal.

INFARMED, IP is the national entity responsible for applying Regulations (EU) 2017/745 and 2017/746 and the national contact point for the purposes of MDR Article 101 and IVDR Article 96.

Ministry of Public Health (MoPH) of Qatar is the competent authority; requests concerning medical devices and equipment in healthcare facilities are submitted to its Facilities Licensing and Accreditation Department.

An 'IMD Committee' is the MoPH body referenced by the official implantable medical device registration application; manufacturers must report certain events to it.

ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România) is designated as the competent authority for medical devices and as the market surveillance authority in the field of medical devices.

ANMDMR is designated as the competent authority for in vitro diagnostic medical devices and as market surveillance authority in that field.

ANMDMR is designated as the responsible authority for notified bodies (designation applications, monitoring, suspension or withdrawal of designation).

Roszdravnadzor (Federal Service for Surveillance in Healthcare, Росздравнадзор) is the competent authority: it performs state registration of medical devices, controls their circulation, monitors safety of devices in circulation, maintains the State Register of Medical Devices, accepts and records activity start notifications, and licenses production and technical maintenance of medical equipment (Regulation approved by Government Decree No. 323 of 30.06.2004).

The Rwanda Food and Drugs Authority (Rwanda FDA) is a regulatory body established by Law No 003/2018 of 09/02/2018. One of its functions is to regulate matters related to the quality, safety and performance of medical devices including in vitro diagnostics in order to protect public health by increasing their access and availability. The law's Article 9 is the enabling provision for the technical regulations and guidelines, and Article 8 paragraph 15 gives the Authority the mission to build cooperation and partnership for harmonisation of practices with regional and international bodies.

The Saudi Food and Drug Authority (SFDA) is the competent authority for medical devices: no device may be traded in the Kingdom without SFDA registration and Marketing Authorization (MDMA). Manufacturers, Authorized Representatives and healthcare providers must report adverse events to SFDA's National Center for Medical Device Reporting (NCMDR).

Device regulation in Senegal is exercised by the Agence sénégalaise de Réglementation pharmaceutique (ARP). Décret n° 2023 2419 never names the Direction de la Pharmacie et du Médicament: it makes registration, import, export, distribution and sale of medical devices subject to an agrément delivered by 'la structure en charge de la réglementation' (art. 27), and art. 31 makes the pharmaceutical regulation structure the coordinator of device regulation, while art. 42 places market surveillance with the Ministry of Health. The ARP's arrêté confirms the position operationally: the marketing authorisation for class B, C and D devices is issued by decision of the ARP's Directeur Général (art. 17), import of any device requires an ARP authorisation (art. 25), and establishment agréments for device manufacture, distribution and export are granted by the ARP's Directeur Général (arts. 2 3, 8 10, 27). The arrêté's visas record that the ARP was created by Décret n° 2022 824 du 7 avril 2022, as modified by Décret n° 2023 2418 du 27 décembre 2023.

Agencija za lekove i medicinska sredstva Srbije (ALIMS, Medicines and Medical Devices Agency of Serbia) is the competent authority for medical devices: it performs registration, amendments, renewal and removal from the Register of Medical Devices, keeps the Register of Manufacturers/authorised representatives, recognises foreign conformity documents and CE marking, approves and controls clinical trials, conducts market surveillance and vigilance, determines product status (whether a product is a medical device), and approves import of unregistered devices.

The Ministry of Health exercises inspection supervision through a medical devices inspector, issues manufacture and wholesale distribution licences, decides classification disputes between manufacturer and conformity body on a prior ALIMS opinion, and may prohibit marketing and order withdrawal of devices.

The Health Sciences Authority (HSA) is 'the Authority' that administers the Health Products Act 2007 and the Health Products (Medical Devices) Regulations 2010 for medical devices.

Štátny ústav pre kontrolu liečiv (ŠÚKL, State Institute for Drug Control) is the national competent authority overseeing the safety, quality and effectiveness of medicines and medical devices in Slovakia, including IVDs.

The Medical Devices Section (Sekcia zdravotníckych pomôcok) of ŠÚKL runs the national device agenda: intake of registrations/notifications of devices and IVDs, market surveillance and inspections, vigilance, and clinical investigation / IVD performance study permissions. Published contacts: pomocky@sukl.sk, vigilanciazp@sukl.sk, clinical investigation md@sukl.sk.

Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP, Agency for Medicinal Products and Medical Devices) is the competent authority implementing ZMedPri 1, Regulation (EU) 2017/745 and Regulation (EU) 2017/746, and is also responsible for notified bodies; exceptions: the Ministry of Health handles the EU reference laboratory appointment procedure and the Commission of the Republic of Slovenia for Medical Ethics (KME) performs ethics committee tasks.

SAHPRA (South African Health Products Regulatory Authority), through its Medical Devices Unit, is the national authority regulating the licensing of medical device establishments and the registration of medical devices (IVD and non IVD) in South Africa.

SAHPRA Radiation Control licenses radiation emitting devices under the Hazardous Substances Act 15 of 1973: electronic generators of ionising radiation (Group III, Regulation R1332 of 1973) such as X ray equipment, linear accelerators and cyclotrons; radioactive sources above 4 kBq (Group IV, Regulations R246 and R247 of 1993); and listed electronic products (Regulation R1302 of 1991) including MRI systems and Class 3B/4 lasers.

MFDS (식품의약품안전처, Ministry of Food and Drug Safety) is the competent authority: it grants manufacturing business licences, product approvals/certifications and import licences, and receives adverse event reports.

Besides MFDS, special self governing city/province mayors and city/county/district heads can order sales suspension, recall, disposal or other measures for hazardous devices and publicise the fact.

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS; Spanish Agency of Medicines and Medical Devices) is the competent authority for medical devices for the purposes of Article 101 of Regulation (EU) 2017/745, irrespective of the competences of other Spanish health authorities.

Spanish regional health authorities (comunidades autónomas) grant the operating licence for custom made device manufacturing, receive the prior start of activity communication from distributors and sellers, and validate serious incident notifications received via NotificaPS before remission to AEMPS; AEMPS and the regions cooperate on registers, market control and surveillance.

National Medicines Regulatory Authority (NMRA) is the authority responsible for medical devices in Sri Lanka; all devices falling under the Act's definition must be registered with the Authority, and licences are required for manufacturing, importation, re packaging, sale, distribution and offering for sale.

Technical evaluation of device registration applications is carried out by the Medical Device Evaluation Committee (MDEC), formed under the NMRA Act, considering quality, safety, effectiveness, need and cost; approved applications go to the CEO and then the Licensing Division issues certificates.

Läkemedelsverket (Swedish Medical Products Agency) is the Swedish competent authority for medical devices and IVDs under MDR/IVDR, responsible for market control and supervision of actors that manufacture or market devices in Sweden and for their products; it does not decide which devices are used in Swedish healthcare or their pricing/reimbursement.

Läkemedelsverket holds supervision over compliance with MDR/IVDR, with a carve out in 5 kap. 2 § förordning (2021:631) placing certain supervision concerning health and medical care activities (e.g. in house manufactured devices under MDR Art. 5(5) and UDI storage within healthcare) on Inspektionen för vård och omsorg (IVO).

Swissmedic (Swiss Agency for Therapeutic Products; in the Therapeutic Products Act 'das Institut', Schweizerisches Heilmittelinstitut, TPA Art. 4) is the competent authority for medical devices and IVDs: it grants product exceptions, designates conformity assessment bodies, operates swissdamed, and conducts market surveillance and vigilance oversight.

The central authority may commission legal entities or associations to run technical personnel training and to conduct device firm inspections covering Act Art. 22 QMS matters and Act Art. 24 GDP matters. Training bodies must be established at least three years and pass the TTQS quality assessment; inspection bodies need at least three full time inspectors with documented procedures. Accreditation lasts three years (extension applied 12 to 6 months before expiry, capped at three years) and an administrative contract must be signed within one year. Inspectors must recuse themselves from cases involving devices they designed, manufactured, supplied or serviced (or within five years of such roles), records are kept at least six years, and sub delegation of inspection work is prohibited.

Ministry of Health and Welfare (MOHW) is the competent authority at the central level for medical devices; municipal and county/city governments are the local competent authorities. The Ministry's Food and Drug Administration (TFDA) administers the regime in practice (all subordinate regulations were issued by TFDA).

The Tanzania Medicines and Medical Devices Authority (TMDA) is the authority that approves registration of medical devices in Mainland Tanzania, acting under the Tanzania Medicines and Medical Devices Act, Cap. 219 R.E. 2023.

The Act's import/export control operates on trade 'into Mainland Tanzania'; TMDA's device regime covers Mainland Tanzania only.

Thai FDA (สำนักงานคณะกรรมการอาหารและยา) under the Ministry of Public Health administers the Medical Device Act B.E. 2551 (2008) as amended; the Minister of Public Health has charge of and enforces the Act.

The competent authority for medical devices in Tunisia is the Agence Nationale du Médicament et des Produits de Santé (ANMPS). ANMPS defines and operates the contrôle technique à l'importation (CTI) procedure through which a medical device obtains its Autorisation de Mise à la Consommation (AMC), and it describes 'Contrôle technique à l'importation (AMC)', 'Contrôle des dispositifs médicaux et des compléments alimentaires' and 'Matériovigilance pour les dispositifs médicaux' as its own activities. ANMPS is a public establishment of a non administrative character with legal personality and financial autonomy, under the tutelage of the Ministry of Health, created by loi n° 2023 2 du 12 juillet 2023, which places medical devices within its field of competence. The Directorate of Pharmacy and Medicines (DPM) still appears as a distribution channel and as a linked legacy site, not as the decision maker.

TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu), the Ministry of Health agency defined as 'Kurum' in the regulation, executes the Turkish Medical Device Regulation.

S.I. 2014 No. 29 makes the National Drug Authority the registering authority for surgical instruments in Uganda: every surgical instrument must be registered by the Authority before sale or distribution in Uganda, and the Authority registers the instruments that meet the safety and efficacy standards it determines. The Authority's device remit is registration, licensing of manufacturers/importers/suppliers, GMP inspection of local and foreign manufacturing sites, labelling approval, advertising vetting, adverse event receipt and suspension of registrations. NDA regulates the import, manufacture, export and supply of medical devices, and states that it does so under a ministerial decree ADM.140/323/01 of 20 July 2020 together with a Surgical Instruments and Appliances Regulation.

State Service of Ukraine on Medicines and Drugs Control (Держлікслужба, DLS) is responsible for applying the medical device technical regulations, state market surveillance, and maintaining the Register of persons responsible for placing devices on the market; the Ministry of Health approves the register procedure; the Ministry of Economy designates conformity assessment bodies.

CMU Resolutions 759/2026 and 758/2026 add medical devices and IVDs (with accessories) to the state market surveillance product list of CMU Resolution 1069/2016 under the responsibility of Держлікслужба (new items 18 2 and 20 2).

The Emirates Drug Establishment (EDE) grants marketing approvals for medical products, including Medical Equipment, under Federal Decree Law 38/2024. The law also assigns functions to the Ministry and competent health authorities within their respective jurisdictions.

The law defines a Competent Health Entity as a local government body concerned with health affairs within its jurisdiction. The Ministry and competent health authorities have licensing and oversight responsibilities alongside EDE, including the licensing of pharmacy practice.

The Medicines and Healthcare products Regulatory Agency (MHRA) operates the UK medical device regime on behalf of the Secretary of State, who has the statutory duty to enforce the Medical Devices Regulations 2002 for relevant devices and devices for performance evaluation.

Under the Medicines and Medical Devices Act 2021, MHRA can issue compliance notices, suspension notices, safety notices and information notices to manufacturers and others in the marketing and supply chain, and can recall a device where no alternative steps would sufficiently protect health or safety.

The U.S. Food and Drug Administration (FDA), through the Center for Devices and Radiological Health (CDRH), is the competent authority regulating medical devices and radiation emitting medical products marketed in the United States under the Federal Food, Drug, and Cosmetic Act.

Ministry of Public Health (MSP), División Productos de Salud Departamento de Tecnología Médica (currently organised as Departamento de Evaluación de Tecnología) evaluates registration applications for medical products: diagnostic reagents, therapeutic devices and medical equipment.

The Dirección General de la Salud (DIGESA) of the MSP exercises the sanctioning power, at the request of the Departamento de Tecnología Médica of the División Productos de Salud.

State registration of medical devices and issuance of registration certificates is carried out by the State Institution "Centre for Pharmaceutical Products Safety" («Фармацевтика маҳсулотлари хавфсизлиги маркази») under the Ministry of Health of the Republic of Uzbekistan.

Presidential Decree PF 137 of 19.08.2025 consolidated medical products and medical equipment into a single category of "medical devices" (тиббий жиҳозлар), classified into four safety (risk) levels, from 1 January 2026.

Department of Health Infrastructure and Medical Devices (Cục Hạ tầng và Thiết bị y tế, IMDA) under the Ministry of Health is the competent authority for medical devices; from 22/11/2025 Circular 44/2025/TT BYT formally decentralizes to IMDA the device procedures listed in its Article 2.

IMDA handles: new Class C/D circulation numbers (Art. 32/32a Decree 98 as amended), post issuance examination (para 3 4 Art. 32), batch suspension (para 3 Art. 34), batch recall (para 4 Art. 34), continuation decisions (Art. 37), number withdrawal (Art. 39), import licences (Art. 48), free sale certificates (Art. 50), verification facility registration (Art. 56), failed verification disposition (Art. 58), and specialized inspection under Decree 217/2025/NĐ CP.

IMDA's online public service portal moves from https://imda.moh.gov.vn to https://vimda.moh.gov.vn on 01/4/2026; the old domain runs in parallel until 30/9/2026. Contact: dmec@moh.gov.vn.

statement: The Zambia Medicines Regulatory Authority (ZAMRA) is a statutory body established under the Medicines and Allied Substances Act No. 3 of 2013. It regulates and controls medicines and allied substances, including the manufacture, importation, exportation, distribution and sale of allied substances, and 'allied substances' are defined by the Act to include medical devices and condoms. A person may not place on the market, advertise, manufacture, sell, import, supply, administer or deal in any medicine or allied substance without a marketing authorisation issued by the Authority. ZAMRA grants that authorisation under section 39 of the Act, and it also issues the device guidelines under section 68.

statement: The Medicines Control Authority of Zimbabwe (MCAZ) is the statutory regulator established by the Medicines and Allied Substances Control Act [Chapter 15:03]. The Act's registration machinery is a Medicines Register and a registration regime for medicines: Part IV is headed 'Registration of Medicines', and the Act's long title confers functions on the Authority 'in relation to the registration of medicines'. Medical devices are not a registrable category in their own right. Devices can only be brought under control if the Minister, after consulting the Authority, makes regulations under section 38(1)(b) covering 'any device or article' used in the diagnosis or treatment of a physical or mental state in man. Two such instruments exist the Condom Regulations (SI 183 of 2005) and the Gloves Regulations (SI 1 of 2006) and MCAZ's own 2026 2030 Strategic Plan records the Medical Devices Unit's functions as the regulation and quality conformity assessment of male condoms and medical gloves only, with a proposed Medical Products and Allied Substances Control Bill needed to 'expand scope to medical devices'.