Regulatory hubs
Explore each authority’s role and browse ElendiLabs articles tagged for that jurisdiction.
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North America
Overview of Health Canada and Medical Device Regulation
An overview of Health Canada's Medical Devices Directorate, the federal authority regulating the safety, efficacy, and quality of medical devices in Canada.
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Overview of FDA Medical Device Regulation and CDRH Role
A detailed guide to the FDA Center for Devices and Radiological Health (CDRH), covering device classification (Class I, II, III), regulatory pathways like 510(k) and PMA, and post-market surveillance.
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Europe
Overview of the Department of Health Affairs and Medical Product Regulation in Monaco
An overview of Monaco's Department of Health Affairs (Direction des Affaires Sanitaires), its division of health products, and its role in enforcing medical device and healthcare standards.
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Overview of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and Medical Device Registration in Russia
An overview of Roszdravnadzor's role as the central competent authority managing medical device registration, classification, testing requirements, and market surveillance in the Russian Federation.
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Overview of the State Medicines Control Agency (VVKT) and Medical Product Regulation in Lithuania
An overview of Lithuania's State Medicines Control Agency (VVKT), its supervisory functions, compliance with EU regulations, and its role in protecting public health through medical product oversight.
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Overview of the State Agency of Medicines (ZVA) and Medical Device Safety in Latvia
An overview of the role of Latvia's State Agency of Medicines (ZVA) in regulating medical devices, managing the LATMED database, and supervising vigilance for public safety.
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Overview of the Estonian Medical Devices and Appliances Database (EMDDB) and Regulatory Framework
An overview of Estonia's Medical Devices and Appliances Database (EMDDB), managed by the State Agency of Medicines (Ravimiamet), highlighting notification requirements under EU MDR and IVDR.
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Overview of the National Agency for Medicines and Medical Devices (AKBPM) and Medical Device Regulation in Albania
An overview of AKBPM, the national competent authority in Albania responsible for medical device registration, regulatory compliance, and market surveillance under Law No. 89/2014.
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Overview of the Medicines and Medical Devices Agency of Serbia (ALIMS) and Medical Device Regulation
An overview of ALIMS, the national competent authority in Serbia responsible for medical device registration, clinical trial approvals, vigilance, and market surveillance harmonized with EU MDR/IVDR standards.
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Overview of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)
An overview of JAZMP, the national competent authority in Slovenia responsible for medical device registration, market surveillance, and materiovigilance under the EU MDR/IVDR framework.
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Overview of the National Organisation for Medicines (EOF) and Medical Device Regulation in Greece
An overview of EOF, the national competent authority in Greece responsible for medical device registration, market surveillance, and materiovigilance under the EU MDR/IVDR framework.
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Overview of the Bulgarian Drug Agency (BDA) and Medical Device Regulation
An overview of the Bulgarian Drug Agency (BDA), the competent authority managing medical device registration, vigilance, and clinical investigations in Bulgaria under EU guidelines.
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Overview of the National Agency for Medicines and Medical Devices of Romania (ANMDMR)
An overview of Romania's ANMDMR, the competent authority responsible for the registration, market surveillance, and vigilance of medical devices under EU regulations.
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Overview of the National Center for Public Health and Pharmacy (NNGYK) and Medical Device Regulation in Hungary
An overview of Hungary's competent authority for medical devices, responsible for market surveillance, vigilance, and compliance with EU MDR/IVDR following the merger of OGYÉI into NNGYK.
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Overview of the State Institute for Drug Control (ŠÚKL) and Medical Device Regulation in Slovakia
An overview of ŠÚKL's role as the competent authority for medical devices in Slovakia, covering registration, vigilance, and market surveillance.
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Overview of the Czech Office for Technical Standardization, Metrology and State Testing (ÚNMZ) and Medical Device Regulation
An overview of ÚNMZ's role in the Czech Republic, focusing on medical device standards, conformity assessment, and the supervision of notified bodies under the EU MDR.
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Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
An overview of the Polish URPL, the central authority responsible for the registration, surveillance, and safety of medical devices in Poland under EU regulations.
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Overview of the Icelandic Medicines Agency (IMA) and Medical Device Regulation
An overview of the Icelandic Medicines Agency's role as the competent authority for medical devices, market surveillance, and compliance with EU MDR/IVDR.
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Overview of the Finnish Medicines Agency (Fimea) and Medical Device Regulation
An overview of Fimea's role as the national competent authority for medical devices in Finland, including market surveillance and vigilance.
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Overview of the Norwegian Medical Products Agency (DMP) and Medical Device Regulation
A comprehensive overview of DMP's role as the Norwegian competent authority for medical devices, covering its regulatory functions, market surveillance, and vigilance under EU MDR/IVDR.
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Overview of the Swedish Medical Products Agency (Läkemedelsverket) and its Medical Device Role
An overview of the Swedish MPA's role as the national authority for medical device regulation, market surveillance, and patient safety in Sweden.
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Overview of the Danish Medicines Agency (Lægemiddelstyrelsen) and Medical Device Regulation
An overview of the Danish Medicines Agency's role in supervising medical devices, managing clinical trials, and ensuring patient safety in Denmark.
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Overview of HPRA and Medical Device Regulation in Ireland
Learn about the role of the Health Products Regulatory Authority (HPRA) in supervising medical devices, clinical investigations, and market safety in Ireland.
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Swissmedic: Overview of Medical Device Regulation in Switzerland
An overview of Swissmedic's role in market surveillance, oversight of conformity assessment bodies, and the legal framework for medical devices in Switzerland.
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Federal Office for Safety in Health Care (BASG) - Austria
An overview of BASG, Austria's regulatory authority for medical devices and medicines, detailing its role in market surveillance and safety.
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FAMHP: Belgium's Medical Device Regulatory Body
An overview of the role and responsibilities of the Federal Agency for Medicines and Health Products (FAMHP) in regulating medical devices in Belgium.
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Overview of the Health and Youth Care Inspectorate (IGJ) - Netherlands
An overview of the IGJ's role in supervising medical devices, ensuring safety and compliance with EU regulations in the Netherlands.
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Italian Medical Device Regulatory Body: Overview and Registration
An overview of the Italian Ministry of Health's role in medical device regulation, focusing on the mandatory national database registration (BD/RDM) during the EU MDR transition.
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INFARMED: Overview of Portugal's Medical Device Regulatory Body
An overview of INFARMED, the Portuguese authority responsible for the regulation, supervision, and safety of medical devices and health products.
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Overview of the Spanish Agency for Medicines and Health Products (AEMPS) and its Role in Medical Devices
Learn about AEMPS, the Spanish regulatory body responsible for medical device safety, classification, and market surveillance under EU MDR.
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Overview of the National Agency for the Safety of Medicines and Health Products (ANSM) and Medical Device Regulation in France
An overview of the role of ANSM in France, focusing on market surveillance, clinical trial authorization, and the safety of medical devices under EU regulations.
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Overview of the Federal Institute for Drugs and Medical Devices (BfArM) and Medical Device Regulation in Germany
An overview of the role of BfArM as the central regulatory authority for medical devices in Germany, including risk assessment, classification, and digital health applications (DiGA).
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Overview of the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Device Regulation in the UK
An overview of the MHRA's role in regulating medical devices in the UK, including the UKCA marking, manufacturer registration, and post-market surveillance.
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Overview of the European Union Medical Device Regulation (EU MDR)
An overview of Regulation (EU) 2017/745, which establishes a robust regulatory framework to ensure the safety and performance of medical devices in the European market.
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Middle East
Asia
Overview of the National Medicines Regulatory Authority (NMRA) Sri Lanka
An overview of Sri Lanka's NMRA, its role under the NMRA Act No. 5 of 2015, and its functions in ensuring the safety, quality, and efficacy of medical devices through registration and licensing.
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Overview of DGDA Bangladesh and Medical Device Regulation
An overview of the Directorate General of Drug Administration (DGDA) in Bangladesh, its regulatory framework for medical devices, and its role in ensuring safety and quality.
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Overview of the Thai FDA and Medical Device Regulation in Thailand
An overview of the Thai Food and Drug Administration's role in regulating medical devices, risk classification systems, and the registration process under the Medical Device Act.
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Overview of the FDA Philippines Medical Device Regulatory Framework
An overview of the Philippine FDA's Center for Device Regulation, Radiation Health, and Research (CDRRHR) and its role in licensing and product registration.
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Overview of the Medical Device Authority (MDA) Malaysia
An overview of the Medical Device Authority (MDA) of Malaysia, its regulatory framework under the Medical Device Act 2012, and its role in ensuring device safety and quality.
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Overview of the Health Sciences Authority (HSA) and Medical Device Regulation in Singapore
An overview of Singapore's HSA, its role in classifying medical devices (Class A-D), and the regulatory requirements for registration and licensing.
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Overview of the Central Drugs Standard Control Organization (CDSCO) Medical Device Regulation
An overview of India's CDSCO, its risk-based classification system (Class A-D), and its role under the Medical Device Rules 2017 in ensuring safety and quality.
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Overview of the Ministry of Food and Drug Safety (MFDS) and Medical Device Regulation in South Korea
Learn about the role of MFDS in South Korea, the risk-based classification system for medical devices, and the mandatory KGMP and product registration requirements.
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Overview of the Pharmaceuticals and Medical Devices Agency (PMDA) and its Role
An overview of Japan's PMDA, the regulatory body responsible for the review, safety, and relief services for medical devices and pharmaceuticals.
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Overview of Taiwan Food and Drug Administration (TFDA) and Medical Device Regulation
A detailed guide to TFDA's regulatory role in medical device registration, quality management (QMS), and safety surveillance in Taiwan.
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Overview of the National Medical Products Administration (NMPA) and Medical Device Regulation in China
An overview of China's NMPA, the regulatory body responsible for medical device safety, classification (Class I, II, III), and the registration process for domestic and imported products.
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Overview of the Medical Device Division (MDD) and MDACS in Hong Kong
An overview of the Medical Device Division (MDD) of the Department of Health and the voluntary Medical Device Administrative Control System (MDACS) ensuring medical device safety in Hong Kong.
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