Regulatory Links – Our special service for you
regular services continually create helpful portals on the subject of regulatory affairs.
Click on the desired topic in the respective country and you will be connected to the selected portal.
Regulatory Authorities
- 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)
MD-Laws and law search sites
- 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
Guidances
Standards
- Harmonised standards MDR
- Harmonised standards IVDR
- ISO Standards
- German Institute for Standardisation (DIN)
Vigilance
Regulatory Authorities
- EU – Medical Devices
- EU – National Competent Authorities – List
- EU – Organisation of Competent Authorities – CAMD
- Notified Bodies – NANDO
MD-Laws and law search sites
- Regulation (EU) 2017/745 consolidated
- Regulation (EU) 2017/746 consolidated
- Corrigenda and implementing measures
- EU-Law – search
- Official Journal of the European Union
Guidances
- MDCG – Medical Device Coordination Group
- EUDAMED – Modules
- EUDAMED Information Centre
- 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 Authorities
MD-Laws and law search sites
- Food Drug and Cosmetic Act
- Food Drug and Cosmetic Act (Chapter V: Drugs and Devices)
- Office of the Law Revision Counsel (all US Codes)
Guidances
- Guidance for Industry and FDA Staff
- Premarket Notification (510(k))
- Premarket Approval (Overview)
- Medical Devices Database
Standards
Vigilance
Regulatory Authorities
MD-Laws and law search sites
- Food and Drugs Act
- Canadian Medical Device Regulation
- Gazette with the publications (search term “Medical Devices Regulations”)
Guidances
Standards
Vigilance
Regulatory Authorities
MD-Laws and law search sites
- HEALTH MONITORING
- 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
- Regulations for IVDs
- Regulations for medical devices
- “cadastro” registration In Vitro Diagnostic (IVD)
- Federal Gazette
Standards
Regulatory Authorities
MD-Laws and law search sites
Regulatory Authorities
- MFDS Website
- National Institute of Food and Drug Safety Evaluation (NIFDS)
- National Institute of Medical Device Safety Information (NIDS)
MD-Laws and law search sites
Guidances
Standards
Regulatory Authorities
MD-Laws and law search sites
- 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
- Application for registration / procedure
Guidances
Standards
- Chinese standards (GB standards only)
- Chinese National Standard List: Medical apparatus and devices in general
- Standards page
Vigilance
Regulatory Authorities
- Ministry of Health, Labour and Welfare
- Pharmaceuticals and Medical Device Agency
- Organization PMDA
- Approved products in Japan
- Registered Certification Bodies (RCB)
- Scope Registered Certification Bodies (RCB)
MD-Laws and law search sites
Guidances
Standards
Vigilance
Regulatory Authorities
MD-Laws and law search sites
Guidances
Standards
Regulatory Authorities
MD-Laws and law search sites
Guidances
Standards
Vigilance
Regulatory Authorities
MD-Laws and law search sites
Guidances
Standards
Vigilance
Regulatory Authorities
MD-Laws and law search sites
Guidances
Standards
Vigilance
Harmonization
Global Health
Clinical data
Standards
Vigilance