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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
- Federal Ministry of Health
- Bundesinstitut für Arzneimittel und Medizinprodukte (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
- Regulation on User Reporting and Information for Medical Devices
Guidelines
Standards
- Harmonised standards MDR
- Harmonised standards IVDR
- ISO Standards
- Deutsches Institut für Normung (DIN)
- German Accreditation Body (DAkkS)
Vigilance
Regulatory bodies
- Federal Ministry of Health
- Bundesinstitut für Arzneimittel und Medizinprodukte (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
- Regulation on User Reporting and Information for Medical Devices
Guidelines
Standards
- Harmonised standards MDR
- Harmonised standards IVDR
- ISO Standards
- Deutsches Institut für Normung (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 Risikoklassifizierung, Melde- und Registrierungsregelungen sowie Kennzeichnungsanforderungen
- RDC 546/2021 – Brasilianische grundlegende Anforderungen
- RDC 36/2015 – Vorschriften für IVDs
- RDC 40/2015 – Vorschriften für Medizinprodukte
- “cadastro” Registrierung In Vitro Diagnostic (IVD)
- Diário Oficial da União (Amtsblatt)
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
- Gesetze in Korea
- MFDS-Gesetze und Information
- Regulation on Medical Device Groups and Class by Group
Guidelines
Standards
Regulatory bodies
MP legislation and search pages
- Laws and Regulations
- Drug Administration Law of the People’s Republic of China No 103
- Vorschriften für die Überwachung und Verwaltung von Medizinprodukten (Verordnung Nr. 739)
- Administrative Maßnahmen für die Registrierung von In-vitro-Diagnostika
- Administrative Measures for the Registration and Filing of Medical Devices
Guidelines
Standards
- Chinesische Normen (nur GB Standards)
- Chinesische nationale Normenliste: Medizinische Apparate und Geräte im Allgemeinen
- Normenseite
Vigilance
Regulatory bodies
- Ministry of Health, Labour and Welfare
- Pharmaceuticals and Medical Device Agency
- Organisation PMDA
- Zugelassene Produkte in Japan
- Registered Certification Bodies (RCB)
- Scope Registered Certification Bodies (RCB)
MP legislation and search pages
- Gesetze in Englisch
- PMDA: Gesetze-Seite (in Englisch)
- QM System Anforderungen
- 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
MP legislation and search pages
Guidelines
Standards
Vigilance
Harmonisation
Global Health
Clinical data
Standards
- International Organization for Standardization (ISO)
- International Electrotechnical Commission (IEC)