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Regulatory Sources – Sources that we use ourselves on a daily basis
Regulatory compliance starts with the right sources. We have compiled the most important regulatory bodies, legislation, guidelines, standards and vigilance resources for you – organised by market and meticulously maintained. Select your target country and navigate straight to the relevant portals.
Regulatory bodies
- EU – Medical Devices
- EU – National Competent Authorities – List
- EU – Organisation of Competent Authorities – CAMD
- Notified Bodies – NANDO
MP legislation and search pages
- Regulation (EU) 2017/745 consolidated
- Regulation (EU) 2017/746 consolidated
- Corrigenda and implementing measures
- EU-Law – search
- Official Journal of the European Union
Guidelines
- MDCG – Medical Device Coordination Group
- The European Association of Medical devices Notified Bodies – Team NB
- EUDAMED – Modules
- EUDAMED Information Centre
- EUDAMED Playground
- European Medical Device Nomenclature – EMDN
- UDI and issuing agencies
- UDI Helpdesk
- Blue Guide Europe
Standards
- Harmonised standards MDR
- Harmonised standards IVDR
- ISO Standards
- European Committee for Standardization (CEN)
- European Committee for Electrotechnical Standardization (CENELEC)
- Harmonised standards MDD
- Harmonised standards AIMD
- Harmonised standards IVDD
Vigilance
Regulatory bodies
- Federal Ministry of Health
- Federal Institute for Drugs and Medical Devices (BfArM)
- Paul-Ehrlich-Institut (PEI)
- Federal Authorities
- Ethic Committees
- German Medical Devices Information and Database System (DMIDS)
MP legislation and search pages
- Official Journal (Bundesanzeiger)
- Deutsches Bundesrecht im Internet
- MPDG
- Act on Liability for defective Products
- Medicinal Products Advertising Act
- Implant Register Act
- Product Safety Act
- Medical Devices Operator Regulation
- Medical devices, User notification and information regulation
Guidelines
Standards
- Harmonised standards MDR
- Harmonised standards IVDR
- ISO Standards
- German Institute for Standardisation (DIN)
- German Accreditation Body (DAkkS)
Vigilance
Regulatory bodies
MP legislation and search pages
- Food Drug and Cosmetic Act
- Food Drug and Cosmetic Act (Chapter V: Drugs and Devices)
- United States Code
Guidelines
- Guidance for Industry and FDA Staff
- Premarket Notification (510(k))
- Premarket Approval (Overview)
- Medical Devices Database
Standards
Vigilance
Regulatory bodies
MP legislation and search pages
- Food and Drugs Act
- Canadian Medical Device Regulation
- Gazette with the publications (search term “Medical Devices Regulations”)
Guidelines
Standards
Vigilance
Regulatory bodies
MP legislation and search pages
- Law No. 5.991/73 6.360/76 “Market Surveillance”
- Decree No 8.077 AUGUST 14, 2013 CONDITIONS FOR COMPANIES SUBJECT TO THE HEALTH LICENSE
- RDC 751/2022 Risk classification, reporting and registration regulations and labeling requirements
- RDC 546/2021 – Brazilian essential requirements
- RDC 36/2015 – Regulations for IVDs
- RDC 40/2015 – Regulations for medical devices
- “cadastro” registration In Vitro Diagnostic (IVD)
- Federal Gazette in the Union
Standards
Regulatory bodies
MP legislation and search pages
Regulatory bodies
- MFDS Homepage (Englisch)
- National Institute of Food and Drug Safety Evaluation (NIFDS)
- National Institute of Medical Device Safety Information (NIDS)
MP legislation and search pages
Guidelines
Standards
Regulatory bodies
MP legislation and search pages
- Laws and Regulations
- Drug Administration Law of the People’s Republic of China No 103
- Regulations for the Supervision and Administration of Medical Devices (Order No. 739)
- Administrative Measures for Registration of In Vitro Diagnostic Reagents
- Administrative Measures for the Registration and Filing of Medical Devices
Guidelines
Standards
- Chinese standards (GB standards only)
- Chinese National Standard List: Medical apparatus and devices in general
- Standards page
Vigilance
Regulatory bodies
- Ministry of Health, Labour and Welfare
- Pharmaceuticals and Medical Device Agency
- Organisation PMDA
- Approved products in Japan
- Registered Certification Bodies (RCB)
- Scope Registered Certification Bodies (RCB)
MP legislation and search pages
- Laws in English
- PMDA: Laws (EN)
- QM-System requirements
- Foreign Manufacturer Accreditation Information
Guidelines
Standards
Vigilance
Regulatory bodies
MP legislation and search pages
Guidelines
Standards
Vigilance
Regulatory bodies
MP legislation and search pages
Guidelines
Standards
Vigilance
Regulatory bodies
- Swiss Agency for Therapeutic Products (swissmedic)
- Market access MD
- Swiss Database on Medical Devices
MP legislation and search pages
Guidelines
Standards
Vigilance
Harmonisation
Global Health
Clinical data
Standards
- International Organization for Standardization (ISO)
- International Electrotechnical Commission (IEC)