Legal basis & guidance by country

Law No. 89/2014 'Për pajisjet mjekësore' (On Medical Devices), as amended by Law No. 21/2020, is the primary statute; Law 21/2020 states it was drafted in partial alignment with Regulation (EU) 2017/745 (MDR). Three Council of Ministers technical rules implement the EU directives: VKM No. 508, 10.6.2015 (active implantable devices), VKM No. 731, 2.9.2015 (essential requirements, conformity, classification, CE of general devices) and VKM No. 189, 9.3.2016 (IVD devices).

Registration procedure is set by Order of the Minister of Health No. 360, 22.08.2016 (procedures, documentation and costs), as amended by Order No. 734, 18.10.2018; licensing conditions for device manufacturers and wholesalers are set by VKM No. 227, 13.4.2022.

Décret exécutif n° 20 324 of 22 November 2020 (JO n° 69), adopted under Art. 230 of loi n° 18 11 of 2 July 2018 on health, governs device homologation; it is completed by ministerial arrêtés of 10 May 2021 (dossier composition, regularization) and 23 June 2021 (modification, export only homologation), amended by décret n° 23 101 of 5 March 2023, with fees set by décret n° 21 551 of 30 December 2021.

Devices marketed without a homologation decision may continue to be supplied but their dossiers must be regularized within two years from 22 November 2022 (i.e. by 22 November 2024), per Art. 44 of décret 20 324 as replaced by décret n° 23 101 of 5 March 2023.

Medical device registration is governed by MERCOSUR Resolución GMC 25/21, incorporated into Argentine law by Disposición ANMAT 64/2025 (published in the Boletín Oficial on 13 January 2025), which derogates Disposiciones ANMAT 2318/02 and 1285/04.

Ley 16.463 subjects the import, export, production, elaboration, fractioning, marketing and warehousing of medicinal specialties and medical technology products to prior authorization and control by the health authority, in establishments enabled by it.

Disposición ANMAT 8194/2023 is the current post market tecnovigilancia regime for medical devices, replacing Disposiciones ANMAT 8054/10 and 7485/11.

The circulation of medical devices in Armenia is regulated in accordance with the Treaty on the Eurasian Economic Union of 29 May 2014, the Agreement on the uniform principles and rules for the circulation of medical devices (medical purpose products and medical equipment) within the framework of the Eurasian Economic Union adopted on 23 December 2014, other international treaties forming part of Armenian law, decisions of the Eurasian Economic Commission, and legislation. The concepts used in Chapter 10 of the Law carry the meanings established by the legal acts of the EAEU bodies.

Article 11 of the Agreement of 23 December 2014 sets the transitional period for medical devices. The Protocol signed in Moscow on 29 December 2025 amends that Article by replacing the words '2025' with '2027' in the first paragraph and the words '2026' with '2028' in the third and fourth paragraphs. The Protocol applies provisionally ten days after signature for member states whose legislation permits provisional application of international treaties; for a member state whose legislation does not, it applies from the date that state completes the domestic procedures needed for its entry into force. It enters into force on the date the depositary receives, through diplomatic channels, the last written notification that the member states have completed those domestic procedures.

Therapeutic Goods Act 1989 (Commonwealth) is the primary legislation: medical devices are defined in s 41BD, and ARTG inclusion, conformity assessment certification, suspension/cancellation and s 60 reconsideration all sit under this Act, supported by the Therapeutic Goods (Medical Devices) Regulations 2002.

The national framework law is the Medizinproduktegesetz 2021 (MPG 2021), BGBl. I Nr. 122/2021, in force since 1 July 2021 (for IVDs since 26 May 2022), as amended by BGBl. I Nr. 192/2021, BGBl. I Nr. 27/2023 and BGBl. I Nr. 102/2024; it governs the national delta on top of MDR/IVDR, alongside the Medizinproduktebetreiberverordnung (BGBl. II Nr. 70/2007) and the Medizinprodukteabgabenverordnung (BASG ordinance on the annual device levy).

The Azerbaijani device registration regime rests on the Law of the Republic of Azerbaijan 'On Medicinal Products' (Articles 1.0.8, 6.1, 6.8, 6.14, 6 2, 9 1) and on Cabinet of Ministers Resolution No. 345 of 18 July 2024, which approved the Rules on state registration of medicinal products, medicinal substances and medical devices, entry in the state register and maintenance of the state register, and repealed the 2007 registration Rules (Cabinet Resolution No. 108 of 13 July 2007). The expertise procedure is set by Cabinet Resolution No. 502 of 25 December 2019.

The governing instrument for medical devices and IVDs is Resolution No. (48) of 2020 on the control of the quality of medical devices and products, issued by the Chairman of the Supreme Council of Health on 14 Jumada I 1442 / 29 December 2020, published in Official Gazette No. 3504 of 31 December 2020 (pp. 39 45) and in force from the day after publication, i.e. 1 January 2021 (Article 18). It was amended by Resolution No. (69) of 2024, published in Official Gazette No. 3781 of 21 November 2024 and in force from 22 November 2024, which replaced the definition of 'Facility' and Articles (3), (6), (7), (9) and the first two paragraphs of Article (10), added the definition of low risk home use devices, added Article (7) bis, added a sentence to Article (12) and revoked the definitions of 'Importer' and 'Distributor'. Detailed requirements sit in NHRA guidelines and circulars issued under Article (16), which empowers the CEO to issue the requirements, controls, procedures, standards and decisions necessary to implement the Resolution.

DGDA's Medical Device files page (last updated 4 March 2026 when checked) lists the 'Registration Guidelines for Medical Devices, Bangladesh 2015' and an imported device checklist.

Primary legislation: ঔষধ ও কসমেটিকস্ আইন, ২০২৩ (Drugs and Cosmetics Act 2023, Act No. 29 of 2023), dated 18 September 2023 and effective immediately; in case of conflict between the Bangla and English texts the Bangla text prevails.

The Drugs and Cosmetics Act 2023 repeals the Drugs Act 1940 and the Drugs (Control) Ordinance 1982; rules, notifications, orders, directions, forms, circulars and approvals made under them continue in force, as far as consistent with the new Act, until repealed, amended or re made; licences, registrations and Marketing Authorization Certificates already issued are deemed issued under the new Act.

Core acts in force on 2026 08 25: Healthcare Law № 2435 XII of 18.06.1993 (as amended 08.07.2024), Art. 391; CM Resolution № 211 of 28.04.2026 (national registration, repeals CM Res. 1269/2008); CM Resolution № 177 of 14.03.2024 (vigilance and recalls); CM Resolution № 548 of 24.09.2021 (unified list of administrative procedures, as amended 27.07.2026); Minhealth Resolution № 42 of 12.05.2022 (administrative procedure regulations and forms), № 55 of 23.04.2015 (preliminary technical works), № 133 of 02.10.2025 (clinical trials), Order № 1324 of 16.12.2014 (classification); EAEU Agreement of 23.12.2014 and EAEU acts for the EAEU route.

Belgium implemented the MDR nationally through the Law of 22 December 2020 on medical devices, with the Royal Decrees of 28 April 2021 (modifying/withdrawing provisions), 12 May 2021 (implementing the law) and 18 May 2021 (clinical investigations). The IVDR was implemented through the Law of 15 June 2022 with Royal Decrees of 13, 14 and 25 September 2022 (the latter on IVD performance studies).

The Law of 22 December 2020 provides five sanction levels for infringements; level 5 is a criminal fine of EUR 2,000 to 200,000 plus imprisonment of two to five years. Level is raised one notch for fraud, serious harm, abuse of professional trust or recidivism within five years (Art. 90); attempted offences receive the minimum penalty (Art. 91); a settlement (transaction, Art. 93) extinguishes the public action.

statement: The Manual para Registro Sanitario de Dispositivos Médicos is the technical instrument that sets the requirements and procedure for device registration, and AGEMED's circulars identify it as approved under Resolución Ministerial N° 0010 of 17 January 2006. AGEMED still applies it: Circular 86/2023 cites numeral 2.9.2 under that resolution and Circular 63/2024 cites numeral 2.3.3 under the same resolution. · article: Numeral 1 and numeral 1

statement: For regulatory purposes, 'medicamentos reconocidos por Ley' under Article 4(g) of Ley N° 1737 of 17 December 1996 explicitly include 'dispositivos médicos, substancias para diagnóstico y reactivos para laboratorio clínico', so both medical devices and in vitro diagnostic reagents fall under the Ley del Medicamento and its Reglamento DS 25235. · article: Art. 4(g)

The operative instrument for medical devices in Bosnia and Herzegovina is the Ordinance on Medical Devices (Pravilnik o medicinskim sredstvima), Official Gazette of BiH No. 4/10 of 19 January 2010. It was adopted by the Minister of Civil Affairs of BiH on the proposal of the Expert Council of the Agency, on the basis of Article 99(7), Article 100(4), Article 106(5), Article 112(3) and Article 113(4) of the Law on Medicinal Products and Medical Devices of Bosnia and Herzegovina (Official Gazette of BiH No. 58/08).

The Ordinance on Medical Devices entered into force on the eighth day after its publication in the Official Gazette of BiH and applies until regulations transposing the relevant European Union directives are adopted. That transposition has not been completed, which is why the Agency has instead issued transition guidances applying the MDR and IVDR transition periods administratively within the existing 2010 framework.

BoMRA has published the Medicines and Related Substances (Medical Devices including In Vitro Diagnostics) Regulations, 2026 and the Medicines and Related Substances (Fees, Levies and Penalties) Regulations, 2026 as drafts. Both carry blank publication and making dates, and BoMRA's 31 August 2026 press release confirms the regulations are 'both still in draft form and open for stakeholder input'. Their reliance provisions therefore create no present route to market.

The registration obligation that governs medical devices sits in section 23(1) of the MRSA 2013, which prohibits importing, exporting, manufacturing, distributing, selling, promoting, advertising or dispensing 'any medicine or cosmetic' unless it is registered by the Authority. Because section 2 defines 'medicine' to include any medical device, a medical device must be registered before those activities. Section 23(3) lets the Authority exempt a medicine (and therefore a device) from that requirement in special circumstances.

The successor statute, the Medicines and Related Substances Act, 2025, received assent on 24 December 2025 but has not commenced: the published copy states 'Date of commencement: ON NOTICE', and section 1 provides that it comes into operation on a date the Minister appoints by Order published in the Gazette. It therefore does not yet govern medical device registration, and the operative regime remains MRSA 2013 plus the MRS Regulations 2019 and BoMRA's published guidelines.

RDC 751/2022 is the operative medical device regulation in force from 1 March 2023; it revoked, among others, RDC 185/2001 (Art. 66).

RDC 830/2023 is the operative IVD regulation (risk classification, notification/registration regimes, labeling and IFU), in force from 1 June 2024; it revoked RDC 36/2015 and other prior IVD acts (Art. 69).

RDC 848/2024 sets the essential safety and performance requirements for medical devices and IVDs; conformity is verified by the sanitary surveillance authority at GMP inspection, at registration/notification, or at sanitary surveillance.

Under Lei 6.360/1976 Art. 12, no product subject to the law, including imports, may be manufactured, offered for sale or delivered for consumption before being registered with the Ministry of Health (functionally ANVISA).

The only Brunei statute that imposes a product registration requirement is the Medicines Act, Chapter 285, and it expressly excludes medical devices: 'medicinal product' is defined as 'any substance or article (not being an instrument, apparatus or appliance)', and both the prohibition on unregistered supply (s. 10(1)) and the power to register (s. 11(1)) attach only to a 'medicinal product'. No Medical Devices Act, Order or Regulations exists in the Laws of Brunei Darussalam.

National framework: Law on Medical Devices (Закон за медицинските изделия, ЗМИ), promulgated SG No. 46 of 12.06.2007, in force from 12.06.2007, last amended SG No. 41 of 10.05.2024. ЗМИ remains the national basis for registration, wholesale trade permits, clinical investigations, vigilance and market surveillance alongside the directly applicable MDR/IVDR.

Cambodia deposited an Instrument of Acceptance of the ASEAN Agreement on Medical Device Directive on 27 March 2019, as recorded by the ASEAN Secretariat's Treaty Division; because AMDD Art. 22(2) puts the Agreement in force only among Member States that have ratified or accepted it, the AMDD became binding on Cambodia on that date.

Cambodia is a signatory of the ASEAN Agreement on Medical Device Directive (AMDD), signed at Bangkok on 21 November 2014; the instrument was signed for Cambodia by Sun Chanthol, Senior Minister and Minister of Commerce.

Medical device fees (MDL application review, MDEL, right to sell) are charged under the Fees in Respect of Drugs and Medical Devices Order (SOR/2019 124).

act: Food and Drugs Act (R.S.C., 1985, c. F 27) · regulations: Medical Devices Regulations (SOR/98 282), consolidated current to 2026 06 21 · recent amendments: Includes SOR/2024 136 (added s.63.2 recall notice) and SOR/2026 96 (s.43 amendment)

Decreto Exento N°25/2026 (promulgated Santiago, 6 March 2026; published in the Diario Oficial on 19 March 2026) incorporates 39 categories of medical devices and IVDs into the sanitary control regime of Article 111 of the Código Sanitario and D.S. N°825/1998, requiring ISP registro sanitario. Entry into force is staggered by a schedule counted from publication (Art. primero transitorio); a technical instructive for applications must be issued within 12 months of publication.

Decreto Supremo N°825/1998 (Reglamento de Control de Productos y Elementos de Uso Médico), together with Article 111 of the Código Sanitario (DFL 725/1968), governs medical devices: they may only be manufactured, imported, marketed or distributed with certification of quality conformity.

Primary legislation: Regulations on the Supervision and Administration of Medical Devices (医疗器械监督管理条例), State Council Decree No. 739, in force since 2021 06 01.

Decreto 4725 de 2005 is amended by Decreto 3275 de 2009 (scope, Art. 1) and Decreto 582 de 2017 (application procedure Art. 21 and automatic modification regime Art. 30).

Decreto 4725 de 2005 (signed 26 December 2005, in force from its publication, repealing Decreto 2092 de 1986) governs registros sanitarios, permiso de comercialización and sanitary surveillance of medical devices for human use at every stage (production, import, export, processing, packaging, storage, sale).

Resolución 4816 de 2008 (Ministerio de la Protección Social) establishes the Programa Nacional de Tecnovigilancia, the mandatory adverse event reporting system for medical devices in Colombia.

Resolución 1405 de 2022 (published Diario Oficial 52.120, 8 August 2022) adopts the semantic standard and UDI DI coding for medical devices and IVDs.

Medical devices are governed by technical regulation RTCR 505:2022 (classification, registration, importation, labeling, advertising, vigilance and control), approved by Decreto Ejecutivo N° 43902 S; it repealed most articles of the former Decreto N° 34482 S (2008) and any reference to 34482 S in other rules is read as a reference to 43902 S.

Satellite instruments referenced by RTCR 505:2022: Decreto 37988 S (Regístrelo portal, incl. review deadlines), Decreto 32780 (EMB fees), Decreto 39342 S (Sistema Nacional de Tecnovigilancia), Decreto 24037 S (ionizing radiation protection), Decreto 43789 S (renewal by notification), Decreto 36868 S (advertising of products of sanitary interest), Decreto 43896 S (market withdrawal/recall).

Registrations approved before RTCR 505:2022 entered into force remain valid until their original expiry.

Côte d'Ivoire's medical device regulation derives from UEMOA Décision n° 03/2022/CM/UEMOA of 24 June 2022, which adopted the guidelines harmonising medical device regulation across the Union's member states. The decision allocates device authorisations to the pharmaceutical regulatory authority of each member state and gave member states twenty four months from its entry into force to establish the institutional and legal framework for implementation. The AIRP's published device procedure is expressly issued under this decision.

The implementing act does not restate the substantive device rules: it determines the competent authorities, the procedure of the competent authorities, supervision and the penalty provisions for implementing the two EU regulations. Its substantive provisions are limited to the national layer — the distributor register, the unique registration number for manufacturers, authorised representatives and importers, the registration of custom made device manufacturers, the national derogation, clinical investigation approval, vigilance, market surveillance, fees and the national language rule.

The Croatian implementing act for the EU medical device and IVD regulations is the Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima, published in Narodne novine no. 100/2018 of 14 November 2018 and adopted by the Croatian Parliament on 31 October 2018. It enters into force on the eighth day after publication, i.e. 22 November 2018.

Resolución CECMED No. 22/2020 (Boletín Ámbito Regulador No. 00 365, 03/04/2020) approved, on a transitory basis, modifications to the requirements of the Reglamento para la Evaluación y el Control Estatal de Equipos Médicos during the COVID 19 pandemic, including keeping in course inscription audits pending and extending BPM and free sale certificates to 31/10/2020; it entered into force on the date of signature.

Regulación E 132 25 'Política del CECMED para la regulación de los dispositivos médicos', approved by Resolución No. 63/2025 of 23/07/2025 and in force from its publication in Boletín Ámbito Regulador No. 00 513, covers all medical devices including IVDs (DMDIV). It renames 'equipo médico' to 'dispositivo médico' and the former 'Registro' process to 'Autorización de Comercialización'; pre existing regulaciones will be updated progressively.

CYMDA's legislation page lists the Cypriot instruments adopted for harmonisation with the acquis: the Basic Requirements laws on specified categories of products (Οι περί των Βασικών Απαιτήσεων που πρέπει να πληρούν Καθορισμένες Κατηγορίες Προϊόντων Νόμοι του 2002 έως 2013), together with the Basic Requirements (Medical Devices) Regulations 2003 to 2013, the Basic Requirements (Active Implantable Medical Devices) Regulations 2003 to 2009, and the Basic Requirements (In Vitro Diagnostic Medical Devices) Regulations 2003. Decree No. 6 (language) and Decree No. 7 (notification) were made under article 59(1)(ζ) of those laws.

Cyprus is an EU Member State, so Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) are binding in their entirety and directly applicable. CYMDA describes itself as the competent authority for the safety and compliance of medical devices and in vitro diagnostic medical devices placed on the Cypriot market and for the application of Regulations (EU) 2017/745 and 2017/746 and the relevant national legislation.

Decree No. 377/2022 Sb. implements certain provisions of Act No. 375/2022 Sb. (issued by the Ministry of Health under the empowering clause § 68 of the Act; e.g. content of documentation of devices in use, details of clinical trial notification).

Act No. 375/2022 Coll., on medical devices and in vitro diagnostic devices, is the national law implementing MDR/IVDR, effective 22 December 2022 (replacing Act No. 268/2014 Coll. as the device law). Consolidated text in force from 1 January 2026 is published on the e Sbírka opendata portal.

authority: State Institute for Drug Control (SÚKL) · submissionSurface: EUDAMED for MDR/IVDR actors and devices; ISZP national system for notifications under §§ 8, 13, 22 and 23 of Act 375/2022 Sb. and MDR/IVDR Art. 16(4) repackaging reports; RZPRO legacy register transitionally for clinical investigation applications, device notification and FSC · verifiedHighlights: The current national basis is Act No. 375/2022 Sb., effective 22 December 2022.; ISZP operated by SÚKL since 7 March 2024 per § 7 of the Act.; Distributors, service persons and custom made manufacturers have national ISZP notification duties.

Violation of MDR/IVDR (and rules issued under them), or of the national device regulation's core duties, is punishable in Denmark: fine or imprisonment up to 1 year and 6 months for violating the EU regulations themselves (lov om medicinsk udstyr § 6(2)), and fines for violating BEK 1731/2025 provisions on language, incident reporting, registration and clinical trials (BEK 1731 § 20). Corporate entities can be held criminally liable.

authority: Danish Medicines Agency (Lægemiddelstyrelsen) · submissionSurface: EUDAMED plus Danish national registration for distributors and specialty retailers · verifiedHighlights: National framework: lov om medicinsk udstyr (LBK 682/2023) and Bekendtgørelse om medicinsk udstyr m.v. (BEK 1731 af 08/12/2025, in force 1 January 2026, repealing BEK 837/2023), supplementing MDR, IVDR and Implementing Regulation (EU) 2022/2346.; Further national instruments listed by DKMA: fee regulations BEK 839/2023 and BEK 1733/2025, advertising regulation BEK 715/2022, RoHS regulation BEK 1369/2024, and lov 799/2020 on products and market surveillance.

statement: The registration of sanitary products rests on the Ley General de Salud (Ley 42 01) and on Decreto 246 06 (Reglamento de Medicamentos) as amended, together with Resolución 000020 and Resolución 000016 which fix the DIGEMAPS service fees, Resolución No. 000004 of 27 January 2016 which creates the simplified procedure and the recognition of foreign certificates, Resolución 000011 on sanitary notification and automatic renewal, and Decreto 117 18 as amended by Decreto 45 23 on automatic renewal of sanitary registrations. · sourceApproval: none · targetJurisdictionId: dominican republic · edgeType: no reliance route · marketAccessStrength: none · regulatoryLayer: market oversight · localApplicationRequired: Yes · targetDecisionRetained: Yes

Resolución ARCSA DE 2026 003 DASP (signed 28 Apr 2026) issues the substitute Normativa Técnica Sanitaria for registration, control and surveillance of medical devices; it enters into force nine months after signature, i.e. on 2027 01 28.

Resolución ARCSA DE 026 2016 YMIH (published Registro Oficial Suplemento 921, 12 Jan 2017), as reformed (incl. ARCSA DE 2023 001 VSVZ and ARCSA DE 2023 033 AKRG), is the operative sanitary technical norm for medical device registration; it is expressly repealed by Resolución ARCSA DE 2026 003 DASP when that resolution enters into force.

Device rules are issued as EDA Chairman decrees, including No. 429/2021 (registration of devices holding international quality certificates), No. 642/2021 (label data of medical/laboratory devices and diagnostic reagents), No. 469/2021 (variations to registered devices), No. 424/2022 (registration of local devices without international quality certificates), No. 190/2022 and No. 88/2022 (import approvals for medical devices/accessories/spare parts and supplies).

Law No. 214 of 2020 regulates clinical medical research in Egypt; its executive regulation is PM Resolution No. 927 of 2022. EDA's clinical trial oversight guideline (EDREX.GL.Bioinn.006 v5/2026) must be read with both.

Law No. 151 of 2019 establishes the EDA (with the Unified Procurement Authority); its executive regulations were issued by Prime Minister's Resolution No. 777 of 2020 (29/03/2020), which contains the fee categories for device applications.

UDI requirements for medical devices, accessories and IVDs are set by EDA Chairman Decree No. 499 of 2021, implemented by guideline EDREX:GL.CAMD.005 (v02/2026).

The Estonian national act for medical devices is the Medical Devices Act (Meditsiiniseadme seadus, MSS), passed 13 October 2004 and published RT I 2004, 75, 520, in force since 1 December 2004. The consolidated text in force at the research date is RT I, 12.07.2025, 23, valid 1 October 2025 to 30 September 2026.

The primary instrument is the Food and Medicine Administration Proclamation No. 1112/2019. Article 20(1) mandates registration and marketing authorization of medical devices; Article 19(1) provides that the rigour of regulatory assessment be commensurate with the product's type, nature and potential risk to human health (the basis for the four risk classes and the low risk abbreviated route); Article 23(1) prohibits any institution from engaging in medical device trade unless registered and licensed. The operative instruments are the EFDA guideline series: GDL/046 (general marketing authorization), GDL/097 (non IVD registration requirements), GDL/087 (IVD registration requirements), GDL/092 (low risk devices), GDL/041 (non IVD classification), GDL/043 (IVD classification) and GDL/098 (post approval change).

The Medical Device Coordination Group (MDCG) endorsed guidance documents published on the Commission website guide the application of MDR/IVDR but are stated by the Commission to be not legally binding.

Devices under IVDD (98/79/EC) are governed by the Act on certain medical devices prescribed in EU directives (629/2010, formerly the Act on health care devices and supplies); that act also sets the requirements that AIMDD/MDD devices must meet to be placed on the market under MDR Art. 120(3). Transition provisions follow MDR Art. 120, 122, 123 and IVDR Art. 110, 112, 113.

Laki lääkinnällisistä laitteista (719/2021) is the Finnish act giving national effect to MDR (EU) 2017/745 and IVDR (EU) 2017/746; it entered into force on 19 July 2021 and applies to IVD scope devices and operators from 26 May 2022.

Ordonnance n° 2022 582 of 20 April 2022 adapted French law to Regulation (EU) 2017/745: it rewrote CSP articles L5211 1 to L5211 3 2 (definitions, ANSM authority, derogations, declarations, single use reprocessing ban), the materiovigilance articles L5212 x, the advertising articles L5213 1 to L5213 5, created the clinical investigation chapter L1125 1 to L1125 32 (ANSM scientific review plus CPP ethics review), and set criminal sanctions (e.g. up to 2 years and EUR 150,000 for failure to report serious incidents; up to 5 years and EUR 375,000 for placing non conforming devices on the market).

Décret n° 2026 299 of 17 April 2026 (JORF 21 April 2026, in force 22 April 2026) recast the device provisions of the regulatory part of the Code de la santé publique: articles R5211 1 to R5211 13 were rewritten, the former R5211 14 to R5211 74 (CE conformity, notified body and old declaration sections, including the national classification rules basis) were abrogated, and the materiovigilance chapter was restructured (new articles R5212 52 to R5212 54); pharmacist traceability duties (section 5, incl. R5212 41) are deferred to 1 September 2026.

In Georgia the binding form of a product requirement is the technical regulation. Any binding act containing technical standards must be adopted in the form of a technical regulation; technical regulations are adopted only under a law or by an ordinance of the Government of Georgia; and a technical regulation takes effect from the moment of its registration in the registry of technical regulations. Georgia recognises the technical regulations of the European Union in the regulated areas, and the Code's own definition of a 'new approach technical regulation' is a technical regulation adopted by the European Commission on the basis of the related new and global approach directive; products manufactured in compliance with new and global approach directives adopted or approved by the European Commission are stated to meet the basic safety requirements under the Code. The device specific instrument in Georgia is therefore a technical regulation — the only one registered for medical devices is Government Decree No. 386 of 3 October 2023 on the clinical investigation of medical devices, as amended by Decree No. 334 of 7 October 2024 — and the medicines statute supplies the rules for the three device type categories it pulls into pharmaceutical registration.

The Medizinprodukterecht Durchführungsgesetz (MPDG, official long title: Gesetz zur Durchführung unionsrechtlicher Vorschriften betreffend Medizinprodukte) is Germany's national act implementing MDR and IVDR, adding national duties (notifications, language rules, clinical trial provisions, vigilance procedure) and criminal/administrative fines provisions (Kapitel 9).

The Medizinprodukte Betreiberverordnung (MPBetreibV, 'Verordnung über das Betreiben und Benutzen von Medizinprodukten', 2025 recast) imposes national duties on operators (Betreiber) of medical devices, including operator duties (§ 3), a device safety officer (Beauftragter für Medizinproduktesicherheit, § 6) and reprocessing rules (§ 8).

The Medizinprodukte Anwendermelde und Informationsverordnung (MPAMIV: Verordnung über die Meldung von mutmaßlichen schwerwiegenden Vorkommnissen bei Medizinprodukten sowie zum Informationsaustausch der zuständigen Behörden) is the national ordinance governing reporting of suspected serious incidents and authority information exchange (it replaced the MPSV).

authority: Federal Institute for Drugs and Medical Devices (BfArM) · submissionSurface: EUDAMED mandatory layer plus DMIDS transitional/special workflows · verifiedHighlights: BfArM publishes DMIDS access forms, instructions and special authorisation workflows.; The page documents the 28 May 2026 EUDAMED transition and states that automatic DMIDS transfer is unavailable.

Public Health Act, 2012 (Act 851), Part 7 is the enabling legislation for medical device registration, import control, safety monitoring and enforcement in Ghana.

Clinical trials in Ghana, including trials of medical devices, are regulated under Public Health Act 2012 (Act 851) Part 8, ss.150 166; current guideline FDA/CTD/GDL ACT/2024/05 dated 15 January 2024.

Guideline for Registration of Medical Device, document FDA/MCH/MDD/GL RMD/2013/01, version 02, date of issue 1 March 2016, is the current registration guideline posted by FDA Ghana.

Guideline for Registration of Software as a Medical Device, document FDA/MCH/MDD/GL RSAMD/2017/03, version 01, issued 1 December 2017.

Greek national device framework: ΔΥ8δ/Γ.Π.οικ130648/ΦΕΚ Β' 2198/02 10 2009 (MDD harmonization), ΔΥ8δ/Γ.Π.οικ130644/ΦΕΚ Β' 2197/02 10 2009 (AIMD), ΔΥ8δ/οικ3607/892/ΦΕΚ Β' 1060/10 08 2001 (IVDD); additional national legislation listed by EOF: ΔΥ8δ/Γ.Π.οικ.1348/ΦΕΚ Β' 32/16 01 2004 (good distribution practice), ΔΣ/ΕΟΦ 6209/2009 (ΦΕΚ Β' 199/06 02 2009) (GMP specifications for medical aids), Law 3370/2005 (ΦΕΚ Α' 176) amending Law 1316/1983, and ΔΥΓ3α/Γ.Π 139307/05 (ΦΕΚ Β' 1098/10 08 2006) on fees (παράβολα). MDR/IVDR apply directly; no single MDR transposition law — the brief's anchors Ν. 5036/2023 (tax law) and 4529/2018 (antitrust damages directive) are NOT device laws.

authority: National Organization for Medicines (EOF) · submissionSurface: EUDAMED plus EOF national medical device register (GREMDIS, services.eof.gr/gremdis) and EOF forms for applicable national duties · verifiedHighlights: EOF publishes current medical device supporting documents and forms (forms page updated July 2026).; EOF separately maintains medical device notification, vigilance and distribution/production materials.; EOF legislation page lists the EU regulations and the national harmonization/additional legislation.

The DRCPFA's power to issue the device technical norms derives from AG 712 99 Art. 4, from Art. 35 of the MSPAS Organic Regulation (Acuerdo Gubernativo 115 99) and from the Código de Salud. NT 37 v5 2016 states that legal foundation on its face, citing Constitution Art. 96, Código de Salud (Decreto 90 97) Arts. 182–183 and AG 712 99 Arts. 70–72.

AG 712 99 Art. 10 confines the 'registro sanitario de referencia' to pharmaceutical specialities, biological products, radiopharmaceuticals, homeopathic products and pesticides. Medical devices and IVDs are absent from that list, which is why they are handled through the 'inscripción sanitaria' of productos afines (Arts. 42 and 44, renewed under Art. 49) and the technical norms instead.

Article 9 of the Acuerdo Gubernativo 712 99 defines the 'productos afines' subject to sanitary control, and its list includes 'materiales de curación y médico quirúrgicos' and 'reactivos de laboratorio para uso diagnóstico'. This is the legal basis that brings medical devices and IVDs inside the MSPAS control regime.

No Hong Kong ordinance specifically regulates the manufacture, import, distribution, supply and use of medical devices; the voluntary MDACS guidance framework applies instead.

A statutory medical device control framework is under development by the Government; until enacted, requirements are set out in non statutory MDD documents (Guidance Notes GN 00 to GN 10, Technical References TR 003 to TR 008, Codes of Practice and the recognised standards list).

The national implementation for in vitro diagnostic devices was carried out by amending Decree 8/2003. (III. 13.) ESzCsM rendelet on in vitro diagnostic devices.

The MDR is directly applicable EU law in Hungary; the national implementation for medical devices was carried out by amending Decree 4/2009. (III. 17.) EüM rendelet on medical devices (consolidated text maintained on NJT).

authority: NNGYK (Nemzeti Népegészségügyi és Gyógyszerészeti Központ), Medical Device Department (Orvostechnikai Főosztály); official site ogyei.gov.hu · submissionSurface: National filings go through Hungarian e administration (e ügyintézés under 2015. évi CCXXII. törvény, Company Gate cégkapu); economic operator registration uses the mandatory EUDAMED Actor module; current national forms are published on the ogyei.gov.hu Orvostechnika pages · laws: 4/2009. (III. 17.) EüM rendelet (medical device national delta, as amended); 8/2003. (III. 13.) ESzCsM rendelet (IVD national delta, as amended); 12/2025. (III. 31.) BM rendelet (periodic review details, from 2025 04 01); 1997. évi CLIV. törvény (Eütv. parent health act: fines 101/B §, implant register 101/C §); 235/2009. (X. 20.) Korm. rendelet and 33/2009. (X. 20.) EüM rendelet (clinical investigations)

Detailed rules for periodic technical reviews (időszakos felülvizsgálat) of devices are set by Decree 12/2025. (III. 31.) BM rendelet, in force from 1 April 2025, replacing the earlier 34/2009 EüM rendelet.

The Icelandic Medical Devices Act (lög um lækningatæki nr. 132/2020) entered into force on 26 May 2021, the same day the MDR became applicable, and it is the national act that carries Iceland's device duties: scope, definitions, competent authority, CE marking, advertising and claims, labels and instructions for use, classification, manufacturer/importer/distributor duties, notified bodies, operator registration, UDI, market surveillance, vigilance, inspections, withdrawal and prohibition, fees, penalties, appeals and regulation making powers.

Iceland is an EEA/EFTA state, not an EU member state. Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2020/561, 'as they are taken up in the Agreement on the European Economic Area', have the force of law in Iceland with the adaptations following from EEA Joint Committee Decisions No 288/2019 and No 301/2019 of 13 December 2019 and No 90 of 18 June 2020, read with Protocol 1 on horizontal adaptation to the EEA Agreement and the EEA Act No. 2/1993. The incorporation is made by Article 2 of the Medical Devices Act (lögfesting), not by EU membership.

Reglugerð nr. 907/2022 (in force 6 August 2022, last amended by Reg. 1268/2025) implements into Icelandic law a list of EU instruments relating to medical devices, each one cited with the EEA Joint Committee decision that took it up into the EEA Agreement — including Commission Regulation (EU) No 722/2012 (EEA JCD 141/2013), Implementing Regulation (EU) 2017/2185 (EEA JCD 144/2021), Commission Implementing Decision (EU) 2019/939 on issuing entities (EEA JCD), and Implementing Regulation (EU) 2021/2078 on EUDAMED (EEA JCD 242/2022 of 23 September 2022). It repeals Regulations No 1296/2013, 906/2021 and 482/2022.

From 1 April 2020 all devices notified under s.3(b) of the Act must be registered with the CLA on the Online System for Medical Devices (registration voluntary for 18 months, then mandatory); the exemption of registered devices from full licensing ends 30 months after notification for Class A/B and 42 months for Class C/D.

Medical Devices Rules, 2017 (notified as G.S.R. 78(E) dated 31 January 2017) under the Drugs and Cosmetics Act, 1940 govern medical devices and IVDs; the rules came into force on 1 January 2018.

PMK 5/2026 revoked several device regulations but preserved parts: PMK 4/2014 (CDAKB/GDPMD) survives except Pasal 2 and its Annex; PMK 20/2017 (CPKB/device GMP) survives except Pasal 2 and Annexes I II; PMK 63/2017 (device clinical trial GCP) survives except Pasal 8, 9, 11, 12, 18, 19, 20 and Annexes I II.

Framework chain: Law 17/2023 on Health (Pasal 138, 143) as primary law; Permenkes 5/2026 on Perbekalan Kesehatan (in force 4 May 2026) as the operative device framework, revoking PMK 62/2017 (izin edar) and PMK 60/2017 (import surveillance); PMK 14/2021 (OSS risk based business/product standards) remains in force; PMK 62/2017 implementing rules continue to apply insofar as not contradictory (PMK 5/2026 Pasal 124).

Implementing arrangements for health supply regulation must be adjusted to PMK 5/2026 within at most 1 year from its promulgation (i.e. by 4 May 2027); until then pre existing implementing rules continue unless contradictory.

The earlier 'آیین‌نامه تجهیزات پزشکی' remains applied for specific provisions: Article 47 (used device import ban), Article 1 note (چ) (scope/RUO borderline) and Article 6 (Medical Equipment Commission approving technical officers) are cited by IFDA university offices in official guidance.

Device manufacturing licensing rests on: (1) Law on Medical, Pharmaceutical and Food Affairs (قانون مربوط به امور پزشکی و دارویی و مواد خوردنی و آشامیدنی); (2) Regulation on Activity in the Medical Equipment Sector (آیین‌نامه فعالیت در حوزه تجهیزات پزشکی); (3) Directive on Issuance and Renewal of Manufacturing Licenses (دستورالعمل صدور و تمدید پروانه ساخت تجهیزات و ملزومات پزشکی); (4) Directive on Storage and Warehousing (دستورالعمل انبارش و نگهداری تجهیزات و ملزومات پزشکی).

COSQC's legal basis is Law No. 54 of 1979 (amended) covering standards, metrology and quality control; its metrology department also applies the Weights and Measures Branding Law No. 42 of 1978 (amended).

KIMADIA is governed by the Public Companies Law No. 22 of 1997 (as amended) and its Rules of Procedure No. 1 of 1999.

Public procurement of medical equipment in Iraq uses Ministry of Planning standard bidding documents (الوثائق القياسية); a dedicated standard document for purchasing medical equipment is published (2024) in Arabic, English and combined versions, alongside documents for medical supplies, laboratory supplies and medicines/vaccines.

Ireland's MDR implementation law is the Medical Devices Regulations 2021 (S.I. No. 261 of 2021), made under section 32 of the Irish Medicines Board Act 1995, in operation from 26 May 2021, for the purpose of giving full effect to Regulation (EU) 2017/745.

Medical Equipment Law 5772 2012 (חוק ציוד רפואי, התשע"ב 2012), published in Sefer HaChukim 2357 p. 394 on 14.5.2012, is the primary legislation. Medical equipment may be manufactured and marketed only if it is registered in Israel in accordance with registration conditions, or if it is listed in the Second Addendum to the law (exempt categories).

The AMAR procedures — Registration in the Medical Equipment Register, Renewal of Registration, and Change of Registration — entered into force on 1.1.2025, each with new declaration/affidavit wording for the regular and fast tracks, published in the 'forms for registration' collector on the ministry site.

For devices under MDR Art. 120(3) (4) (legacy directives certificates / devices placed on market before 26 May 2021), national rules continued to apply only to the extent necessary until 27 May 2025. This transitional window has now expired.

Italy's national implementation framework consists of D.Lgs. 5 agosto 2022 n. 137 (adaptation to MDR (EU) 2017/745 and (EU) 2020/561, under Art. 15 of Law 53/2021) and D.Lgs. 5 agosto 2022 n. 138 (adaptation to IVDR (EU) 2017/746), both published in G.U. Serie Generale n. 214 of 13 09 2022 and in force from 28 September 2022.

Core framework: Pharmaceuticals and Medical Devices Act (Act No. 145 of 1960, as amended), with Enforcement Cabinet Order No. 11/1961, Enforcement Rule No. 1/1961, QMS Ordinance No. 169/2004 (manufacturing/quality control) and GVP Ordinance No. 135/2004 (postmarket safety management).

Circulation of medical devices and supplies, sterilants and disinfectants and related products is prohibited until they are authorized (إجازتها) under instructions issued by the JFDA Director General in coordination with relevant official bodies.

The Basis for Import and Circulation of Medical Supplies including Sterilants and Disinfectants 2019 (أسس استيراد وتداول المستلزمات الطبية 2019) was published in the Official Gazette No. 5569 of 1 Apr 2019 and is effective from its publication date.

JFDA service fees are set by the Fees and Rewards Regulation No. 19 of 2015 (published in Official Gazette No. 5333 of 16 Mar 2015, effective from publication, repealing Reg 72/2003); the device circulation fee paragraph (ط) was added by the 2020 amendment (Gazette No. 5646, 16 Jun 2020).

JFDA Law No. 41 of 2008 (قانون المؤسسة العامة للغذاء والدواء) is cited by JFDA as governing legislation for medical device and supplies services, alongside the Drug and Pharmacy Law 12/2013.

Testing of Medical Supplies, Sterilants and Disinfectants and Cosmetics Regulation No. 41 of 2024 governs mandatory testing and circulation approval of devices/supplies; issued by Royal will upon the Council of Ministers decision of 5 Jun 2024 under Art. 98(a) of Law 12/2013, repealing Regulation 89/2017.

Medical device registration is governed by the Health Code № 360 VI (07.07.2020, Arts. 230 261), Order of the Minister of Health № ҚР ДСМ 16 (09.02.2021) on registration/re registration/dossier amendments, Order № ҚР ДСМ 10 (27.01.2021) on expertise, and EAEU Council Decision № 46 (12.02.2016) on registration and expertise rules.

Binding regime: Pharmacy and Poisons Act (Cap. 244) and the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022 (L.N. 100 of 2022), which contain the application (Form 1), local representative, dossier, variation (rule 13), renewal (Form 4), five year validity (rule 10(1)) and fee (Second Schedule) provisions. Operative guidance: PPB 'Guidelines for Registration of Medical Devices Including In Vitro Diagnostics' (HPTPERHTPGUD011, created April 2022).

Ministerial Decree No. 387 of 2025 was published by the Kuwait Ministry of Health in the Official Gazette Kuwait Al Youm, main edition No. 1773 of 11 January 2026 (22 Rajab 1447 H), at pages 103 118, under the Decisions (قرارات) category. This is the publication record that fixes the instrument's identity and its date of gazetting.

statement: The national medical device regulation is Cabinet Regulation No. 461 'Medicīnisko ierīču noteikumi' of 15 August 2023, adopted under Article 34(2)(2) (5) of the Medical Treatment Law and Article 7(1) (2) of the Conformity Assessment Law. It was published in Latvijas Vēstnesis No. 161 of 22 August 2023 and entered into force on 23 August 2023, replacing Cabinet Regulation No. 689 of 28 November 2017. It has been amended, most recently by Cabinet Regulation No. 824 of 22 December 2025. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

statement: The national in vitro diagnostic medical device regulation is Cabinet Regulation No. 582 'In vitro diagnostikas medicīnisko ierīču noteikumi' of 10 October 2023, adopted under Article 34(2)(2), (3), (4) and (5) of the Medical Treatment Law and Article 7(1) (2) of the Conformity Assessment Law. It was published in Latvijas Vēstnesis No. 198 of 12 October 2023 and entered into force on 13 October 2023. It has been amended, most recently by Cabinet Regulation No. 825 of 22 December 2025. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

statement: There is no separate Latvian 'Medical Devices Law'. The statutory basis for device and IVD regulation is Article 34(2) of the Medical Treatment Law (Ārstniecības likums, adopted 12 June 1997, in force 1 October 1997), which empowers the Cabinet of Ministers to determine clinical investigation and performance study procedures, essential requirements, single use device reprocessing and market placement, the registration of manufacturers, devices and distributors, and distribution, operation, vigilance, post market and technical surveillance. · sourceApproval: · targetJurisdictionId: · edgeType: · marketAccessStrength: · regulatoryLayer: · localApplicationRequired: No · targetDecisionRetained: Yes

Decision No. 1506/1 of 1 September 2014 sets out explanatory provisions for the application of Decision No. 455/1. It defines implantable medical devices (Art. One), classifies and codes devices under GMDN (Art. Two), classifies devices by risk level in a table mapped across the EU, US, Japan, Australia, Switzerland and Canada with Annex 1 listing the accepted European conformity documents by class (Art. Three), adds a mandatory IMDRF free sale certificate or certificate for foreign government to the registration documents (Art. Four), adopts the amended DMI 02 identification card (Art. Five) and stops customs endorsement of imported implantables not recorded with the Programs and Projects department from 1 April 2015 (Art. Six).

Decision No. 455/1 of 16 April 2013 regulates the importation and use of medical materials. Article One imposes a conformity certificate on all imported medical equipment, instruments and supplies, adopting mandatory Lebanese standards where they exist and, where they do not, the non mandatory Lebanese standards or the requirements issued by the European Union or one of the United States of America, Canada, Japan and Australia.

The National Procedure for the Regulation of Medical Devices in Lebanon, Version 1 of November 2013, lays down the requirements and conditions for importing medical devices together with the qualifications required of suppliers. It is structured as Part 1 (importation of medical devices) and Part 2 (filing and processing of operator declarations and device registrations), and it states the MOPH's regulatory strategy of guaranteeing conformity to international standards while optimising the use of available resources.

The EWR In vitro Diagnostika Verordnung (EWR IvDV, LGBl 2022 Nr. 143, in force 26 May 2022) regulates the placing on the market of IVDs in the EEA in Liechtenstein per EEA Agreement Annex II Chapter XXX, in particular Regulation (EU) 2017/746; Arts. 19 20 were amended by LGBl 2022 Nr. 214.

The EWR Medizinprodukteverordnung (EWR MepV, LGBl 2021 Nr. 161, in force 26 May 2021) regulates the placing on the market of medical devices in the EEA in Liechtenstein; its annex incorporates Regulation (EU) 2017/745 (incl. as amended by Regulation (EU) 2020/561) as directly applicable and generally binding law in Liechtenstein.

authority: Amt für Gesundheit (Office of Public Health) · instruments: EWR MepV (LGBl 2021 Nr. 161) national MDR delta, in force 26 May 2021; EWR IvDV (LGBl 2022 Nr. 143) national IVDR delta, in force 26 May 2022; Heilmittelgesetz (LGBl 2015 Nr. 23) Swiss side umbrella law via customs treaty; Verwaltungsvereinbarung Amt für Gesundheit/Swissmedic (LGBl 2024 Nr. 74) dual system cooperation · eeaRegistration: EUDAMED (EU level database, not a national surface) · nationalSurfaces: Notifications and declarations to the Amt für Gesundheit under EWR MepV Arts. 12 13 and EWR IvDV Art. 14; Swissmedic for customs territory registrations

The Liechtenstein Heilmittelgesetz (HMG, LGBl 2015 Nr. 23) implements the Swiss therapeutics legislation that is applicable in Liechtenstein under the customs treaty of 1923, covering medicinal products and medical devices; for devices it covers post market control and the designation of the ethics commission for clinical trials. It leaves the EEA rules on medicines, tissues and cells untouched (Art. 1(2) HMG).

The device chapter of HSL I 552 was amended by Law XIII 2947 (effective 2021 05 26, TAR 2020 11067), Law XIV 1059 (effective 2022 05 26, TAR 2022 09668), Law XIV 2745 (effective 2024 06 21, TAR 2024 11248), and Law XIV 2746 (effective 2024 06 21, TAR 2024 11251).

Law XIII 2947 Art. 14(2): the EUDAMED era provisions of the amendment package (Arts. 5 and 10 of Law XIII 2754, i.e. the EUDAMED based registration/notification and duties regime) enter into force on 2022 11 26, or — if EUDAMED was not fully functional on 2021 05 26 — 24 months after the European Commission's notice that EUDAMED fully performs its functions.

The national regime is set in Articles 59 1 to 59 6 of the Health System Law (Sveikatos sistemos įstatymas) No. I 552, inserted by Law No. XIII 2754 of 2019 12 20; Article 59 1 governs placing on the market and distribution of devices meeting Regulation (EU) 2017/745 (or the national IVD technical regulation, later aligned to Regulation (EU) 2017/746).

Alongside MDR/IVDR, the marketing, importation, advertising and use of medical devices in Luxembourg are governed by: loi modifiée du 16 janvier 1990 relative aux dispositifs médicaux; Règlement grand ducal modifié du 5 février 1993 (active implantable medical devices); Règlement grand ducal modifié du 11 août 1996 (medical devices); Règlement grand ducal modifié du 24 juillet 2001 (in vitro diagnostic medical devices).

Until the EUDAMED Vigilance and Clinical Investigation modules enter into force, several information exchange provisions of Directives 90/385/EEC, 93/42/EEC and 98/79/EC remain applicable and are regulated at national level — e.g. national provisions on device registration, economic operator registration and clinical investigation authorisation.

Administrative Regulation No. 11/2026 'Implementing Rules of the Medical Device Supervision and Administration System' (醫療器械監督管理制度施行細則), Official Gazette No. 20/2026 of 2026 05 18 (pp. 25 69), supplements Law 12/2025 with procedural detail: dossiers, labels, review clocks, licences, records.

Law No. 12/2025 'Medical Device Supervision and Administration System' (醫療器械監督管理制度), published in Official Gazette No. 30/2025, is the primary statute; it establishes registration, filing and business activity licensing for medical devices.

The regime is completed by 4 Chief Executive dispatches (including Dispatch 141/2026 personal use import amount and Dispatch 142/2026 designated regions), 2 Secretary for Social Affairs and Culture dispatches (including Dispatch 36/2026 classification catalogue) and 26 ISAF technical directives (including 1/ISAF/2026 classification rules, 6/ISAF/2026 nomenclature and label technical requirements, 12/ISAF/2026 filing dossier requirements).

The Medical Device (Advertising) Regulations 2019 came into operation on 1 July 2020.

Framework: Medical Device Act 2012 (Act 737); Medical Device Regulations 2012 (P.U.(A) 500); Medical Device (Advertising) Regulations 2019 (P.U.(A) 317); Medical Device (Duties and Obligations of Establishments) Regulations 2019 (P.U.(A) 318); Medical Device (Exemption) Order 2024 (P.U.(A) 78); Medical Device (Amendment) Regulations 2025 (P.U.(A) 330); Medical Device (Designated Medical Device) Order 2026 (P.U.(A) 10).

The Medical Device Regulations 2012 came into operation on 1 July 2013.

The national legal basis for medical devices is the Medical Devices and In Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations (S.L. 458.59), made under the Medicines Act (Cap. 458) by Legal Notice 321 of 2020 and in force since 4 August 2020. It is deliberately derivative: S.L. 458.59 reg. 2 defines a 'medical device' as any device defined in Article 2(1) of Regulation (EU) 2017/745 and any IVD defined in Article 2(2) of Regulation (EU) 2017/746. The Union Regulations are therefore the substantive rules and S.L. 458.59 supplies the national enforcement, registration, inspectorate and penalty layer. The Authority lists three national instruments for devices: S.L. 458.46 (Medicines Authority (Fees) Regulations), S.L. 458.59 and S.L. 458.61 (Testing of COVID 19 Regulations).

The Ley General de Salud consolidated text in force carries latest reforms of DOF 15 01 2026; Art. 376 (registration) was reformed DOF 10 05 2023 and 15 01 2026, and Art. 262 (device definition) was reformed DOF 10 05 2023.

The notification and registration of CE marked medical devices in the State Register is currently governed by AMDM Order no. Rg04 264 of 08.09.2026, which approved a new normative package comprising an administrative procedure and a use instruction for the electronic service "personal cabinet of the authorised representative". AMDM states that the new framework institutes a digitalised, simplified administrative procedure consistent with the principles and requirements of the relevant European framework, including Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). The procedure itself states that the decisive deadlines, substantive requirements, rejection grounds and applicant liability are established exclusively by the Procedure, and that the Instruction annexed to the order deals only with operating the electronic service.

Moldova is not a member of the European Union or of the European Economic Area, so Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) do not apply in Moldova of their own force, and CE marking is a foreign approval that Moldova recognises through its own law rather than a domestic approval. AMDM presents the 2026 procedure as 'în concordanță cu principiile și cerințele cadrului european relevant' and states that the new framework 'facilitează aplicarea coerentă a cerințelor naționale în raport cu cadrul european relevant, inclusiv Regulamentele (UE) 2017/745 (MDR) și (UE) 2017/746 (IVDR)' consistency with the principles and requirements of the relevant European framework rather than direct application. AMDM maintains a separate page for European Union legislation in the device field (Legislația UE, amdm.gov.md/ro/page/legislatia ue dm), on which it lists Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the gradual introduction of Eudamed and the information obligation in the event of interruption or discontinuation of supply, alongside Regulations (EU) 2023/607, 2017/746 and 2017/745.

The conditions for placing medical devices on the Moldovan market are set by three Government Regulations of 2018: HG nr. 702/2018 approving the Regulation on the conditions for placing medical devices on the market, HG nr. 703/2018 for in vitro diagnostic medical devices, and HG nr. 704/2018 for active implantable medical devices. AMDM's administrative procedure recognises that a manufacturer may delegate the initiation of certain conformity assessment procedures under those three Regulations to its authorised representative, and requires that delegation to be reflected in the representation agreement.

The CE track Procedure is made under Legea nr. 102 din 9 iunie 2017 cu privire la dispozitivele medicale and cites the provisions it implements article by article: art. 7 alin. (2) for the pre market notification duty, art. 7 alin. (3) for the mandatory documents, art. 7 alin. (1) for the conditions on grouping devices in one dossier, art. 7 alin. (7) for the examination deadline, art. 7 alin. (10) for the statement that registration is not a permissive act, and art. 17 alin. (1) for the register. The order also invokes the Administrative Code of the Republic of Moldova and the Government decision on AMDM service tariffs.

Minister of Health Order No. A/206 approves the registration procedures: Annex One for medicines and pharmaceutical substances, Annex Two for medical devices, Annex Three for health supplementary products, Annex Four the application form template, and Annex Five the registration certificate template. The Annex Two procedure (Эмнэлгийн хэрэгслийг бүртгэх журам) is the operative rule for IVD registration and for listing of medical equipment and consumables. The order repeals the annexes of Order A/295 of 2019 and Order A/176 of 2023.

The governing instrument is the Law on Medicines and Medical Devices (Эм, эмнэлгийн хэрэгслийн тухай хууль) in its revised edition adopted 5 June 2024 and subsequently amended on 3 July 2026. Article 15.4 delegates the procedure for registering medicines, medical devices, pharmaceutical substances and health supplements to the Government member in charge of health.

statement: Medical devices in Montenegro are governed by the Law on Medical Devices (Sl. list Crne Gore br. 024/19 of 22 April 2019), amended by the Law amending the laws containing provisions on inspection supervision (Sl. list Crne Gore br. 084/24 of 6 September 2024); the consolidated text applies from 1 October 2024. The detailed conditions, manner and procedure for recognising foreign documents and the CE mark, and the content of applications, documentation, registration, renewal, amendment and deletion from the register, are laid down in the Rulebook on the recognition of foreign documents and the CE mark and on the registration of a medical device (Sl. list Crne Gore br. 085/22 of 2 August 2022, 126/22 of 18 November 2022). · instruments: Zakon o medicinskim sredstvima, Sl. list CG 24/19, 84/24; Pravilnik o priznavanju inostranih isprava i CE znaka i o registraciji medicinskog sredstva, Sl. list CG 85/22, 126/22

Décret n° 2 14 607 of 22 kaada 1435 (18 September 2014) is the implementing decree of loi 84 12. It fixes the establishment declaration procedure, the registration application route to the Minister of Health, the decision clock, the five year validity of the registration certificate, the handling of used and refurbished devices, the specific authorisation regime for non registrable devices, and the inspection and sampling powers.

Medical devices are governed by loi n° 84 12 relative aux dispositifs médicaux, promulgated by dahir n° 1 13 90 du 22 chaoual 1434 (30 août 2013) and published in Bulletin officiel n° 6188. It creates the registration certificate requirement, the establishment declaration regime, classification, essential requirements, materiovigilance, traceability, advertising control and penalties, and delegates the detail to implementing texts.

DFDA regulates and classifies medical devices according to the ASEAN Medical Device Directive (AMDD), and hosts the AMDD document on its official website (PDF uploaded October 2024).

nationalAct: Wet medische hulpmiddelen (BWBR0042755, law of 24 October 2019) — competent authorities, supervision, tariffs, exemptions, enforcement · implementationDecree: Besluit medische hulpmiddelen (BWBR0043470) — implant card, fillers, reprocessing of single use devices · ministerialRegulation: Regeling medische hulpmiddelen (BWBR0043450 / Staatscourant 2020, 24039) — language requirements, custom made device lists, free sale certificate, appointment of authorities, notification tariff amendment

Depending on the device, other statutes also apply: Electricity Act 1992 (all electrically powered devices; Energy Safety), Radiation Protection Act 1965 (Office of Radiation Safety), Radiocommunications Act 1989 (Radio Spectrum Management), HSNO Act 1996 (EPA), Contraception, Sterilisation and Abortion Act 1977 (condoms), Human Tissue Act 2008, Health (Needles and Syringes) Regulations 1998, and PECPR Regulations 1999 (autoclaves/pressure vessels). It is the supplier's responsibility to ensure compliance with all applicable legislation.

primaryLegislation: Medicines Act 1981 · secondaryLegislation: Medicines Regulations 1984; Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325, in force 1 January 2004) · notificationDatabase: WAND (Web Assisted Notification of Devices), operated for the Director General of Health · guidancePublisher: Medsafe

NAFDAC published the draft 'NAFDAC Medical Devices, including In vitro Diagnostics and Related Products Regulations, 2026' for comment on 6th February 2026; the comment period is closed. It is not yet in force.

The device registration guidelines must be read in conjunction with IMDRF/GHTF documents, including GHTF/SG1/N71:2012 (definitions), IMDRF IVD MA ToC N13 and nIVD MA ToC N9 (2019 dossier formats), and GHTF/SG1/N70:2011 (label and IFU).

NAFDAC's current official guidance surface is the Guidelines index (nafdac.gov.ng/regulatory resources/guidelines), which catalogues device registration, renewal, variations, conformity assessment, GMP, PMS, PMPF and adverse event guidelines; the application surface is the NAPAMS portal (registration.nafdac.gov.ng), not iRIMS.

NAFDAC Act CAP N1 (LFN) 2004 is the primary legal basis; device registration obligations are stated as 'in accordance with the provisions of NAFDAC Act CAP N1 (LFN) 2004, other related Legislation, and the accompanying Guidelines'.

Medical devices in North Macedonia are governed by the Law on Medicines and Medical Devices (Закон за лековите и медицинските средства), one act covering both medicines and devices. It was adopted as the Law on Medicines and Medical Aids (Закон за лековите и медицинските помагала), Сл. весник на РМ бр. 106/07, and has been amended repeatedly; the amendment chain runs 106/07, 88/10, 36/11, 53/11, 136/11, 11/12, 147/13, 164/13, 27/14, 43/14, 88/15, 154/15, 228/15, 7/16, 53/16, 83/18, 113/18, 245/18, Сл. весник на РСМ 28/21, 122/21, 60/23 and 267/25. There is no separate 'Law on Medical Devices'.

The act was adopted in 2007 as the Law on Medicines and Medical Aids (Закон за лековите и медицинските помагала) and was renamed to the Law on Medicines and Medical Devices (Закон за лековите и медицинските средства) by the amending act in Сл. весник на РМ 88/15, whose own title still carries the old name but whose Член 69 authorises a consolidated text of the 'Закон за лековите и медицинските средства'. From 154/15 onward every amending act is titled with 'медицинските средства'. Older sub legal instruments adopted under the former name (including the still operative device registration rulebook Сл. весник на РМ 151/10) still use the term 'медицински помагала' for the same subject matter.

nationalImplementingAct: Lov om medisinsk utstyr (Act of 7 May 2020 No. 37) · nationalSupplementingRegulation: Forskrift om medisinsk utstyr (FOR 2021 05 09 1476), in force 26 May 2021 · eeaNote: MDR/IVDR apply in Norway via the EEA Agreement (implemented by the act); the forskrift adds national provisions on language, clinical investigations, registration, supervision, exemptions and penalties. · competentAuthority: Direktoratet for medisinske produkter

DSC publishes the device guidance suite: GD1 (Medical Device Listing), GD3 (Class C&D medical devices registration), GD5 (Class C&D IVD registration), GD 22 (manufacturer registration), GD 14 (bundling/grouping criteria), GD 23 (electronic IFU) and Medical Device Reporting guidance (July 2026), plus circulars 126/161/162/173 of 2025.

Royal Decree No. 35/2015 (Law on Regulating the Pharmacy Profession and Pharmaceutical Establishments) and Ministerial Decree No. 113/2020 issuing its Executive Regulation including the medical device bylaws chapter; device regulation is enforced under MD 113/2020.

Rule 74 repeals the Medical Devices Rules, 2015 and all other rules, notifications, orders and instruments made under the DRUGS Act or the DRAP Act in so far as they regulate medical devices and the activities covered by the 2017 Rules, except notification No.F.5 11/2017 SO (Admn) dated 15 March 2017, which survives.

The Medical Devices Rules, 2017 were made by DRAP as S.R.O. 32(I)/2018 dated Islamabad, 16 January 2018, in exercise of powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012) with the approval of the Federal Government, and came into force at once upon publication.

A draft executive decree re regulating Ley 90 (as amended by Ley 92) was published by MINSA on 15 Oct 2025 for public consultation; at CCIAP's request the consultation was extended (MINSA news of 17 Dec 2025, further meetings January February 2026). The draft would derogate DE 148/1999, DE 490/2019, DE 616/2020, DE 40/2022 and Resolución 003/2024, and would take effect six months after promulgation. As of 2026 08 25 it does not appear in MINSA's normativity listing, i.e. not yet in force.

Framework in force: Ley 90 de 26 Dec 2017 (Gaceta 28433 B); amended by Ley 92 de 12 Sep 2019; regulated by Decreto Ejecutivo 490 de 4 Oct 2019 (Gaceta 28875 A), as modified by Decreto Ejecutivo 616 de 13 May 2020, added to by Decreto Ejecutivo 849 de 2 Jul 2020 (Art. 35 A) and Decreto Ejecutivo 1689 de 29 Dec 2020 (amending Art. 35 A); Resolución 852 de 30 Oct 2019 (Licencia de Operación manual) and further DNDM resolutions (001/2021, 066/2021, 091/2021, 111/2021, 037/2022, 001/2023, 004/2023, 694/2023, 003/2024).

Resolution DINAVISA N° 44/2024 establishes the Proceso Simplificado de Registro Sanitario (PSR) for in vitro diagnostic products previously authorised by reference regulatory authorities, on top of the base IVD regime of Resolución DINAVISA N° 266/2022, whose Art. 2 definition of IVD the PSR resolution expressly borrows.

Decreto N° 10403/2012 incorporated into Paraguay's legal order the MERCOSUR Common Market Group resolutions linked to Working Subgroup N° 11 'Health', including the MERCOSUR technical regulation on good manufacturing practice for medical products and IVDs (GMC 20/11) and the serious adverse event information exchange mechanism (GMC 23/11). These form part of the technical regulation layer that Paraguayan device and IVD rules operate on.

Resolución DINAVISA N° 226/2024 (signed 27 August 2024) entered into force on 16 September 2024 and is the instrument that sets the requirements for obtaining, modifying and renewing the marketing authorisation of medical devices.

The MSPBS abrogated Resolución S.G. N° 669 of 19 October 2016 by Resolución S.G. N° 554/2024. The abrogated resolution had regulated Art. 4(b) of Ley N° 4659/2012 and set the rules for obtaining the sanitary registration of products considered medical devices, sharps and personal protective equipment. The abrogation followed a Nota from DINAVISA dated 12 September 2024, after Res. DINAVISA N° 226/2024 had taken over the subject.

Devices are governed by Ley 29459 and Reglamento D.S. 016 2011 SA as amended by D.S. 016 2017 SA (which rewrote Arts. 12, 18, 26, 31, 40, 60, 62, 70, 81, 93, 94, 95, 104, 115, 124 127, 130, 132, 136 and repealed Art. 128), D.S. 018 2019 SA and D.S. 020 2024 SA (advertising Arts. 191 194, adds 194 A); classification and essential principles are set by D.S. 003 2020 SA.

Every mention of 'condiciones esenciales' or 'condiciones esenciales de seguridad y eficacia' in Title IV (Dispositivos Médicos) of D.S. 016 2011 SA is to be read as 'principios esenciales de seguridad y desempeño' under D.S. 003 2020 SA, with the Anexo 2 checklist (Art. 10) used as conformity evidence.

Under FDA Circular 2024 003, Class B/C/D devices not in the registrable list (FC 2020 001 A) could be marketed without CMDN only until 30 September 2024; CMDN applications ceased 1 October 2024; from 1 October 2024 marketing without CMDN/CMDR or a pending application (with proof of payment and document tracking number) is prohibited.

The schedule of fees and charges for medical device authorization follows DOH Administrative Order No. 50 s. 2001 and its amendments and revisions; a 1% Legal Research Fee is added per FDA Circular 2011 003 (RA 3870 as amended).

DOH Administrative Order No. 2018 0002 (adopted 26 January 2018) governs documentary requirements for medical device registration and aligns them to the ASEAN Common Submission Dossier Template (CSDT) under the ASEAN Medical Device Directive; it repeals FDA Memorandum Circular No. 2014 005.

Act of 7 April 2022 on medical devices (Ustawa o wyrobach medycznych, consolidated text Dz.U. 2024 poz. 1620) implements MDR and IVDR in Poland: it sets obligations of economic operators, healthcare institutions and professionals, national registration/notification registers, clinical investigation and performance study procedures, advertising rules, administrative fines and fees. In force 26 May 2022; the advertising chapter (Art. 54 61) applies from 1 January 2023 and the national registers (Art. 21 25) from 1 July 2023. It repeals the Act of 20 May 2010 on medical devices.

Lei n.º 71/2025, de 22 de dezembro executes MDR Chapter VII (clinical investigations) and IVDR Chapter VI (performance studies) nationally: INFARMED decides, CEIC gives the binding ethics opinion, submissions go through the EU electronic system or INFARMED's national electronic system.

Decreto Lei n.º 145/2009 is repealed by DL 29/2024, except provisions kept in force transitionally by Art. 52: arts 9, 10 and 11(1,2,3,5) and 41(1)(b) (registration duties until EUDAMED), Chapter XIII, 61(1)(mm)(nn) and 62 (advertising), and arts 66 68 (IVD, pending the IVDR execution law).

Until a national law executing Regulation (EU) 2017/746 is published, DL 145/2009 arts 66 68 remain in force for IVDs; DL 189/2000 (as amended) also remains the national IVD framework, and INFARMED applies DL 189/2000 art. 12 to IVD wholesale distributors.

Decreto Lei n.º 29/2024, de 5 de abril (as amended by Decreto Lei n.º 118/2025) ensures the execution of Regulation (EU) 2017/745 in the national legal order; it regulates economic operators, health institutions, notified bodies, vigilance, market surveillance and sanctions.

OUG 46/2021 arts. 28 29 sanction breaches of the MDR and of national rules with fines between 2,000 and 20,000 lei depending on the provision and actor (e.g. placing non compliant devices: 10,000 20,000 lei plus withdrawal; language breaches: 2,000 5,000 lei; advertising breaches: 10,000 20,000 lei).

OUG 137/2022 of 12 October 2022 establishes the institutional framework and measures for implementing Regulation (EU) 2017/746 in Romania; procedural norms in Ordin 3753/2023.

authority: ANMDMR (www.anm.ro) · implementingLegislation: OUG 46/2021 of 9 June 2021 (MOf. 588/11.06.2021) — national framework for applying Regulation (EU) 2017/745 · keyDelegatedOrders: Ordin 3539/2022 (MD placing on market, registration), OMS 2845/2022 (custom made), Ordin 2882/2021 (vigilance), Ordin 330/2023 (clinical investigations), Ordin 3467/2022 (fees), OMS 566/2020 (operating permits) · guidanceSurface: ANMDMR publishes forms and procedural pages under dispozitive medicale on www.anm.ro

EAEU route registration is governed by the Rules of registration and examination of safety, quality and efficacy of medical devices approved by EAEU Council Decision No. 46 of 12.02.2016; circulation of devices in the EAEU is regulated by the EAEU Treaty of 29.05.2014, the Agreement on unified principles and rules of circulation of medical devices of 23.12.2014, other Union law treaties, Commission decisions, and member state legislation.

Rules of state registration of medical devices approved by Government Decree No. 1684 of 30.11.2024 are in force from 01.03.2025, replacing the rules under Government Decree No. 1416 of 27.12.2012; amended by Government Decree No. 1206 of 13.08.2025 (published on pravo.gov.ru 15.08.2025).

The legal basis is Law No 003/2018 of 09/02/2018 establishing Rwanda FDA and determining its mission, organisation and functioning, under which the technical regulations DFAR/HMDAR/TRG/002 Rev 2 'Regulations Governing the Registration of Medical Devices including In Vitro Diagnostics' were made. Those regulations came into effect on 20 April 2020; Revision 1 of 8 June 2021 added the article on reliance, the article on emergency use authorisation and the article on donation of medical products; Revision 2 of 22 August 2022 added IVDs as regulated products, added notification applications, and extended the regulations to veterinary as well as human devices. The operative guidance is DHT/GDL/024 Version 2 'Guidelines for Registration of Medical Devices' (November 2025), developed in reference to the Africa Medical Devices Forum, WHO and the International Medical Device Regulators Forum, together with the guidelines on submission of documentation for registration of IVDs.

The Medical Devices Law enters into force 180 days after its publication in the Official Gazette; the Implementing Regulation had to be issued by the SFDA Board within 180 days of the Law's publication and takes effect when the Law takes effect.

Primary legislation is the Medical Devices Law issued by Royal Decree No. (M/54) dated 6/7/1442H; the Implementing Regulation was issued by SFDA Board Decision No. (3 29 1443) dated 19/2/1443H. MDMA requirements (MDS REQ1) are issued under Articles 8 10 of the Law.

Senegal's device framework rests on two instruments. Loi n° 2023 06 du 13 juin 2023 relative aux médicaments, aux autres produits de santé et à la pharmacie defines 'produit de santé' to include medical devices and in vitro diagnostic devices and, in its art. 43, provides that the conditions of manufacture, registration, import and wholesale and retail distribution of medical devices are fixed by decree — it contains no self executing device rules. Décret n° 2023 2419 du 27 décembre 2023 fixant les conditions de fabrication, d'importation, d'enregistrement, d'exportation et de distribution des dispositifs médicaux is that decree: it carries the essential requirements in its Annexe I, the risk classification in art. 3, the authorisation and import routes and the post market surveillance system. An ARP arrêté of 2026 then fixes the establishment agreement modalities under art. 28 of the decree.

Law on Medical Devices (Zakon o medicinskim sredstvima), "Sl. glasnik RS" No. 105/2017, is the current statute. It entered into force on the eighth day after publication and applies 12 months after entry into force (i.e. fully applicable from late 2018 per ALIMS). On its entry into force, the medical device part of the Law on Medicinal Products and Medical Devices ("Sl. glasnik RS" 30/2010, 107/2012) ceased to apply. Existing licences remained valid max 24 months and existing registrations until expiry of the term set in the decision.

Pravilnik o registraciji medicinskog sredstva (Bylaw on Registration of Medical Devices), "Sl. glasnik RS" 84/2018, 58/2021, 6/2023, prescribes the conditions and manner of recognition of foreign documents and the CE mark, the content of the application, the documentation, and the manner of registration, renewal, amendment and removal from the Register of Medical Devices, and the Register of Manufacturers.

Implementing bylaws under the Law on Medical Devices (all listed on ALIMS): essential requirements 65/2018; registration 84/2018, 58/2021, 6/2023; wholesale 84/2018; import of unregistered devices 39/2018, 104/2018, 58/2021; product status 65/2018, 58/2021; clinical investigation 91/2018, 40/2019; GDP guidelines 94/2018; production 102/2018, 58/2021; market monitoring 102/2018, 58/2021; advertising 102/2018 (ispravka 105/2018); suspension/withdrawal and technical assessment 99/2018, 37/2019; labelling and IFU 4/2019, 87/2024; in house manufacture 4/2019; vigilance 3/2019; list of Serbian standards 28/2019.

Medical devices are regulated under the Health Products Act 2007 and the Health Products (Medical Devices) Regulations 2010 (S 436/2010, current as at 26 Aug 2026, latest amended by S 809/2023 wef 18/12/2023); fees are prescribed under the Health Products (Fees) Regulations 2022. HSA publishes the GN guidance library (GN 15 registration, GN 13/GN 14 classification, GN 21 changes, GN 24 change of registrant, GN 35 special access, GN 36 UDI).

For devices placed on the Slovak market before 26 May 2021, the national government regulations implementing the old directives still govern national documentation expectations: NV č. 166/2020 Z. z. (medical devices, Directive 93/42/EHS), NV č. 167/2020 Z. z. (active implantable devices) and NV č. 569/2001 Z. z. (IVDs, Directive 98/79/ES).

Zákon č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach (as amended, including zákon č. 293/2023 Z. z.) is the national law supplementing MDR/IVDR in Slovakia: § 110 registration of IVD manufacturers/EC reps seated in SR, § 110a distributor registration, § 110b notification duty incl. Slovak language label/IFU (ods. 1) and 14 day notification (ods. 2), § 129 ods. 2 písm. aj) free sale certificates.

authority: Agency for Medicinal Products and Medical Devices (JAZMP) · submissionSurface: EUDAMED shared layer plus JAZMP national registration (SPOT portal for distributors/importers, EUDAMED Actors module routed via JAZMP for manufacturers/importers/ARs) and JAZMP forms · verifiedHighlights: JAZMP publishes separate sections for actor registration, device registration, forms, vigilance, clinical investigations and free sale certificates.; The current national basis is the Medical Devices Act ZMedPri 1 (UL RS 40/25, in force 19 June 2025); fees are set by Tarifa JAZMP (UL RS 6/26).

Zakon o medicinskih pripomočkih (ZMedPri 1), published in Uradni list RS No. 40/2025 on 4 June 2025 and in force from 19 June 2025, is the national act implementing MDR, IVDR and Regulation (EU) 2022/123; it covers language requirements, business entity and device registration, advertising, clinical investigations/performance studies, vigilance, fees and offences.

Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs), Regulation No. 1515 published in Government Gazette No. 40480 on 9 December 2016, made by the Minister of Health in terms of section 35(1)(xxvii) of Act 101/1965, govern licensing (reg 5 6), registration (reg 8 12), clinical investigations (reg 16), vigilance (reg 17), advertising (reg 21), labelling/IFU (reg 22 24) and transitional call up (reg 27 28).

Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended by Act 72 of 2008 and Act 14 of 2015, is the primary statute; it broadened regulatory scope to medical devices and IVDs and provides for establishment licensing (s22C(1)(b)), licence validity/renewal (s22D), s21 authorisation for unregistered products, and s36 exemptions.

Medical Device Act Enforcement Rule (의료기기법 시행규칙), Prime Ministerial Decree No. 2127, in force from 2026 07 01, carries the annexes: grade classification criteria [별표 1], facility and QMS standards [별표 2], clinical trial management standards [별표 3], import establishment standards [별표 4], distribution quality management [별표 6], prohibited advertising scope [별표 7], fees [별표 10] and official forms [서식 1 56].

Medical Device Act (의료기기법), Law No. 21263 of 2025 12 30, in force from 2026 07 01, is the primary statute.

Real Decreto 942/2025, de 21 de octubre, por el que se regulan los productos sanitarios para diagnóstico in vitro is the Spanish national decree complementing Regulation (EU) 2017/746 (competent authority, health guarantees, linguistic regime, in hospital manufacture, foreign trade controls); it derogates RD 1662/2000.

Real Decreto 192/2023, de 21 de marzo, por el que se regulan los productos sanitarios is the Spanish national decree developing the member state options of Regulation (EU) 2017/745; it derogates RD 1591/2009 and RD 1616/2009 (active implantables) with named surviving provisions.

authority: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) · submissionSurface: EUDAMED plus national RECOPS commercialization registration, operative since 15 June 2026 (RD 192/2023 art. 18; RD 942/2025 art. 15) · verifiedHighlights: RECOPS launched 15 June 2026; no new CCPS/RPS filings accepted from 28 May 2026 except custom made manufacturers, for whom RPS communication remains mandatory.; RECOPS communication must include the UDI DI and the labelling and instructions for use with which the product is marketed in Spain (RD 192/2023 art. 18.2).

RD 1591/2009 articles 38, 39 and 40 (advertising and promotion, incentives, sponsorship of scientific meetings) remain in force until specific Spanish legislation is developed, per RD 192/2023 disposición derogatoria única.1.a.

With effect from 5 August 2025, all new applications for registration of medical devices are accepted as consolidated dossiers, evaluated under the guideline 'Guideline for consolidated dossier application submission and evaluation of medical device' (GL 034, effective 23.07.2025).

authority: National Medicines Regulatory Authority (NMRA), Medical Device Regulatory Division (MDRD) · hubPage: NMRA medical devices hub publishes registration, variation, waiver (WOR), low risk device registration, application forms, guidelines, monthly fee lists and the list of registered devices · keyGuidelines: GL 034 consolidated dossier guideline (eff. 23.07.2025); GL 037 low risk devices guideline (eff. 13.05.2026); GL 017 recall guideline (eff. 01.02.2021); 2011 registration guideline (legacy CDDA, still linked) · foreignManufacturerRoute: Applications filed through a Sri Lankan Marketing Authorization Holder (local agent)

The National Medicines Regulatory Authority Act, No. 05 of 2015 is the main legislation controlling medical devices in Sri Lanka.

Until Eudamed is fully functional, complementary national requirements on how serious incident and FSCA reporting to Läkemedelsverket must be made are set in Läkemedelsverkets föreskrifter HSLF FS 2021:32.

Sweden's national framework complementing MDR and IVDR: Lag (2021:600) med kompletterande bestämmelser till EU:s förordningar om medicintekniska produkter and förordning (2021:631), in force 15 July 2021 (repealing lag (1993:584) om medicintekniska produkter); Läkemedelsverket regulations HSLF FS 2021:32 with interim national rules for reporting/registration until Eudamed is fully functional; fee ordinance förordning (2021:988); legacy products remain subject to LVFS 2003:11 / 2001:7 / 2001:5.

The Ordinance on In Vitro Diagnostic Medical Devices (IvDO/IvDV, SR 812.219) of 4 May 2022 entered into force on 26 May 2022, except Art. 16(5) and Art. 90(2), which enter into force at a later time.

Implantable Class III custom made devices (Sonderanfertigungen) may be placed on the market until 26 May 2026 without a certificate from a Swiss designated body or an EU/EEA notified body, provided a formal application for conformity assessment was filed by 26 May 2024 and a written agreement was signed by 26 September 2024.

Continued placing on the market of legacy IVDs under Art. 82(1) IvDO requires: continued compliance with previous law; no significant design/intended purpose changes; no unacceptable risk; a QMS per Art. 10(8) EU IVDR established by 26 May 2025; staged formal applications to a designated or EU/EEA notified body (certificate and Class D self declared devices by 26 May 2025; Class C by 26 May 2026; Class B and sterile Class A by 26 May 2027) and written agreements signed four months later in each case (26 September 2025/2026/2027).

Legacy IVDs may continue to be placed on the market until: products with a valid certificate under Art. 81 IvDO, 31 December 2027; self declared old law products whose IvDO assessment requires a designated body Class D until 31 December 2027, Class C until 31 December 2028, Class B and sterile Class A until 31 December 2029.

Continued placing on the market of legacy medical devices under Art. 101(1) MedDO requires: continued compliance with the previous law; no significant changes in design or intended purpose; no unacceptable risk to patients, users or others; a QMS per Art. 10(9) EU MDR established by 26 May 2024; a formal application to a Swiss designated body or an EU/EEA notified body filed by 26 May 2024; and a written agreement with that body signed by 26 September 2024.

Legacy medical devices may continue to be placed on the market until: (a) self declared devices under the old law whose conformity assessment under MedDO requires a designated body, until 31 December 2028; (b) devices with valid old law certificates Class III and implantable Class IIb (except sutures, clips and listed dental products) until 31 December 2027, and other Class IIb, Class IIa, sterile Class I and Class I with measuring function until 31 December 2028.

The Medical Devices Ordinance (MedDO/MepV, SR 812.213) entered into force on 26 May 2021, except Art. 17(5) and Art. 108(2), which enter into force at a later time.

Medical Device Act (醫療器材管理法), 85 articles, promulgated 2020 01 15 by Presidential Order 華總一義字第10900004021號; effective date 2021 05 01 fixed by Executive Yuan Order 行政院院臺衛字第1100001220號 (issued 2021 02 17). No amendments since promulgation (original version in force).

From the Medical Device Act's effective date, device matters are governed by the Medical Device Act and the device provisions of the Pharmaceutical Act (藥事法) cease to apply.

Applications for marketing authorization of medical devices, diagnostics and laboratory equipment are assessed under the Compendium of Guidelines, TMDA/DMD/MDA/G/001 Rev 03, June 2024.

Device classification and control rest on the TMDA (Control of Medical Devices) Regulations, GN No. 315 of 2015, as cited in the official compendium.

Application fees are those specified in the Fees and Charges Regulations in force at the time of application; TMDA's fees page cites 'The Tanzania Medicines and Medical Devices (Fees and Charges) Regulation, 2022' and links a GN No. 686 PDF.

Notification applications must follow the Guidelines on Applications for Notification of Medical Devices and In Vitro Diagnostic Devices, 1st Edition 2022, effective 1 August 2022, covering devices exempted from registration, veterinary devices and medical gases.

Principal legislation: The Tanzania Medicines and Medical Devices Act, Chapter 219, Revised Edition 2023 (principal legislation; renamed and amended by Act No. 8 of 2019).

Medical Device Act B.E. 2551 (2008), as amended by Medical Device Act (No. 2) B.E. 2562 (2019), is the governing statute; the amendment took effect the day after its publication in the Royal Gazette (published 30 April 2019).

Licences and detailed listing receipts issued under the Medical Device Act B.E. 2551 before Act (No. 2) B.E. 2562 took effect remain valid until their expiry.

The operative legal basis for medical device market access in Tunisia is the foreign trade technical control regime, not a device specific law: loi n° 94 41 du 7 mars 1994 relative au commerce extérieur, which defines the foreign trade regime applicable to import and export operations and the technical control arrangements and the bodies empowered to exercise them, and décret n° 94 1744 du 29 août 1994 relatif aux modalités de contrôle technique à l'importation et à l'exportation et aux organismes habilités à l'exercer. ANMPS's device import control procedure names those two instruments as its references, and the only device specific legal texts ANMPS lists among its regulatory texts are narrow sectoral instruments (for example the joint arrêté of 30 December 2020 fixing the technical specifications of masks).

The Medical Device Regulation's other provisions entered into force on 26 May 2021 and it repealed the 2011 MDD based Tıbbi Cihaz Yönetmeliği and the Active Implantable Devices Regulation (both RG 07.06.2011, No. 27957).

The Tıbbi Cihaz Yönetmeliği (RG 02.06.2021, No. 31499 Mükerrer) was prepared on the basis of Article 4 of Law No. 7223 (Product Safety and Technical Regulations Law) and Articles 508 and 796 of Presidential Decree No. 4.

Obligations tied to the EU electronic systems (registration Arts. 29 33(3), clinical investigation Arts. 70 77, vigilance Arts. 85 88, UDI/database provisions and others listed in Madde 111(1)(a)) enter into force 6 months after the EU Official Journal publishes the Commission notice that the relevant system is functional.

The İn Vitro Tanı Amaçlı Tıbbi Cihaz Yönetmeliği's other provisions entered into force on 26 May 2022; it repealed the 2011 IVDD based Vücut Dışı Kullanılan (İn Vitro) Tıbbi Tanı Cihazları Yönetmeliği.

Under the IVD Regulation, vigilance and performance study obligations of the repealed IVDD based regulation continue to apply until the date referenced in the thirteenth paragraph of the entry into force article (i.e. the electronic system dependent date).

Legacy IVDD devices may be placed on the market until 31/12/2027 (class D), 31/12/2028 (class C) and 31/12/2029 (class B and class A supplied sterile).

Devices covered by valid MDD/AIMDD certificates may be placed on the Turkish market until 31/12/2027 (all class III and implantable class IIb except sutures, staple wires, dental fillings, dental brackets, crowns, screws, wedges, plates, wires, pins, clips and connectors) and until 31/12/2028 (other class IIb, class IIa, and class I supplied sterile or with measuring function).

The Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliği (RG 15.05.2014, No. 29001, as amended) rests on Law No. 7223 and Articles 508 and 796 of Presidential Decree No. 4 and governs sales center authorization, advertising and promotion of devices.

The National Drug Authority's operative registration guideline for devices is DAR/GDL/028 Rev 0, 'Guidelines on Registration of Surgical Instruments and Appliances', issued by the Directorate of Product Assessment and Registration. Its revision block records Revision Date 6 Aug 2020, Effective Date 14 Aug 2020 and Review Due Date 14 Aug 2023 — i.e. the review date had passed before this verification and the document is still the version NDA publishes. The guideline states its own legal basis: Act Cap. 206 s. 64(g), and a surgical instruments statutory instrument whose art. 25(1) and (2) require all surgical instruments and appliances to be registered before sale or distribution. It is the instrument that carries the registration tracks, the dossier tables, the appendices and the IMDRF Essential Principles checklist.

The statutory basis for medical device regulation in Uganda is the National Drug Policy and Authority Act, Cap. 206. Section 64(g) empowers the Minister responsible for health to make regulations 'regulating, restricting or prohibiting the importation, sale or advertising of surgical instruments and appliances'. S.I. 2014 No. 29, the National Drug Policy and Authority (Registration) Regulations, 2014, is made under sections 35 and 64 of that Act and applies expressly to the registration of surgical instruments (reg. 2(c)); its Part III (regs. 24 35) is the device Part. The instrument does not use the words 'medical device': the statutory term of art is 'surgical instrument', defined in reg. 24 to include appliances, in vitro reagents and calibrators and software.

CMU Resolution No. 759 of 10.06.2026 approves a new EU MDR aligned Technical Regulation on medical devices; the resolution enters into force 18.12.2026, but the Regulation itself applies from 31.12.2030; it repeals Resolutions 753/2013 and 755/2013.

CMU Resolution No. 758 of 10.06.2026 approves a new EU IVDR aligned Technical Regulation on IVDs; the resolution enters into force 16.12.2026, the Regulation applies from 31.12.2030 (points 353 362 from 01.12.2029; subpoints 2 9 of point 27 from 31.12.2031); it repeals Resolution 754/2013.

Medical devices in Ukraine are governed by three CMU technical regulations of 02.10.2013: No. 753 (medical devices), No. 754 (IVD), No. 755 (active implantable), all in force in the edition of 30.11.2022 and all losing force on 31.12.2030.

EDE was established on 29 September 2023 under Federal Decree Law No. (28) of 2023 establishing the UAE drug establishment/corporation, and regulates medical products under Decree Law 38/2024.

Federal Decree Law No. (38) of 2024 Governing Medical Products, Pharmacists and Pharmaceutical Establishments is the primary law for medical devices ('Medical Equipment'); it entered into force on 2 January 2025.

Federal Law No. (8) of 2019 is repealed; its implementing regulations and resolutions remain in force, without contradiction with Decree Law 38/2024, until replaced.

Medical devices in the UK are regulated under the Medical Devices Regulations 2002 (SI 2002/618, as amended), comprising Parts for general medical devices, active implantable devices, IVDs, Part 4A post market surveillance, approved bodies, fees and enforcement.

The Medical Devices (Post market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 insert a new Part 4A into SI 2002/618 (regs 44ZC to 44ZN) covering post market surveillance plans and reports, periodic safety update reports, trend reporting, serious incident reporting and field safety corrective actions; the SI commences 6 months after making (made 16 December 2024; gov.uk states the requirements came into effect on 16 June 2025).

The Medical Devices (Amendment) (Great Britain) Regulations 2025, in force 24 May 2025, omit regulations 4H, 4J, 4K and 4L of SI 2002/618, cancelling the scheduled revocation of assimilated EU instruments: Commission Decision 2002/364 (IVD common technical specifications), Regulation (EU) 207/2012 (electronic instructions for use), Regulation (EU) 722/2012 (animal tissue devices) and Regulation (EU) 920/2013 (notified body designation).

Legal basis: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) device definition in section 201(h), classification in section 513, PMA in section 515; implementing regulations codified in 21 CFR parts 800 898, including device classification panels in 21 CFR parts 862 892 and premarket pathways in 21 CFR part 807 (510(k)), part 860 (De Novo), and part 814 (PMA).

Decreto N° 35/025 (promulgated 17/02/2025, published 06/03/2025) internalises MERCOSUR GMC Resolución N° 7/24 approving the 'Reglamento Técnico MERCOSUR Requisitos esenciales de seguridad y desempeño de los productos médicos y productos médicos para diagnóstico in vitro', and derogates Decreto N° 152/001 (which had internalised GMC Res. 72/98).

Decreto N° 3/008 'Requisitos para reactivos de diagnóstico, dispositivos terapéuticos y equipos médicos' (promulgated 01/01/2008, published 17/01/2008, Registro Nacional de Leyes y Decretos Tomo 1/2008 p. 9) is the operative national regulation, issued under Decreto Ley N° 15.443 (Ley Orgánica de la Salud Pública) and modified inter alia by Decreto 87/010.

Decreto N° 428/022 (promulgated 27/12/2022, published 20/01/2023, in force from publication) internalises MERCOSUR GMC Resolución N° 25/21 on registration of medical products and derogates Decreto N° 7/001 (which had internalised GMC Res. 40/00).

authority: MSP Departamento de Evaluación de Tecnología (Departamento de Tecnología Médica), División Productos de Salud · submissionSurface: VUCE PIRM electronic transfer plus MSP product specific forms (FO 13222 series) and the MSP 'Manual de Procedimientos Registro de Producto' · verifiedHighlights: Three official trámites: registration/renewal via VUCE PIRM; certificado negativo / desaduanamiento via VUCE TECM; ingreso de un producto médico por uso compasivo.; Downloadable FO 13222 forms (002 021) and LV 13222 checklists per product category.; MSP publishes a procedural manual for product registration (v.5, 08/07).

Cabinet of Ministers Resolution No. 738 of 24.11.2025 (devices Regulation in Annex 2) entered into force on 26.02.2026 and repeals CM Resolution No. 213 of 23.03.2018; all new applications, renewals and changes are examined under No. 738 from 26.02.2026.

Under Article 6 of the Law "On Medicinal Products and Pharmaceutical Activity" (No. 415 I of 25.04.1997, current version), medical purpose products (изделия медицинского назначения) are subject to mandatory state registration; the registration procedure is determined by the Cabinet of Ministers.

Decree 98/2021/NĐ CP is in force as amended by Decree 07/2023/NĐ CP, Decree 96/2023/NĐ CP and Decree 04/2025/NĐ CP (consolidated scan published on IMDA's official library).

Decree 98/2021/NĐ CP on medical device management was issued 08/11/2021 and took effect 01/01/2022.

Circular 44/2025/TT BYT takes effect 22/11/2025 and repeals Circular 19/2021/TT BYT (16/11/2021) on administrative document templates for Decree 98.

statement: Marketing authorisation for a medical device is required by section 39 of the Medicines and Allied Substances Act No. 3 of 2013 and the device guidelines are issued under section 68 of that Act. The operative ZAMRA device instruments are the Guidelines on Application for Grant of Marketing Authorisation of Non In Vitro Diagnostic Medical Devices for Human Use (version 2 published for implementation on 21 June 2024), the Guidelines for Grant of Marketing Authorisation of In Vitro Diagnostic Devices for Human Use (ZAMRA/MA/GUD/0003, version 1.0), the Guidelines on the Principles of Medical Devices Classification (ZAMRA/MA/GUD/0002, version 1, 2018), the Guidelines for Label and Instructions for Use for Medical Devices and the Essential Principles of Safety and Performance of Medical Devices. Renewal is governed additionally by the Medicines and Allied Substances (Marketing Authorisation of Medicines) Regulations (S.I. No. 79 of 2019) and fees by the Medicines and Allied Substances (Fees) Regulations (S.I. No. 38 of 2016).

statement: Medical device control in Zimbabwe rests on the Medicines and Allied Substances Control Act [Chapter 15:03] section 38(1)(b), which lets the Minister of Health, after consulting the Authority, prohibit, control or restrict the manufacture, possession, sale or use of any substance, device or article used for a purpose bringing it into contact with the body, or used in the diagnosis or treatment of a physical or mental state in man. The two instruments actually made under that power for devices are the Medicines and Allied Substances Control (Condom) Regulations, 2005, published in Statutory Instrument 183 of 2005, and the Medicines and Allied Substances Control (Gloves) Regulations, 2006, published in Statutory Instrument 1 of 2006 (the SI number is confirmed by the preamble of the 2014 amending instrument). Both were made under section 74 read with section 38 of the Act and both have been amended by the 2014 instruments. No general medical device registration guideline, classification guideline or device fee schedule is published by MCAZ its Medical Devices documents page carries only the Condom and Glove Regulations, the two 2014 amendments, the registers of approved condoms and gloves, and the laboratory fee schedule.