Regulatory & Standards (182 listings)
The Biomedical Index lists 182 Regulatory & Standards listings from 83 countries, grouped into 6 types. Regulators, standards bodies and official guidance for medical devices. Search this category.
Last updated 2026-11-13.
Regulatory Authorities (92)
- AEMPSSpain · Madrid
- AGEMEDBolivia · La Paz
- Agence Marocaine du Médicament et des Produits de Santé (AMMPS)Morocco · Rabat
- Agence Nationale des Produits Pharmaceutiques (ANPP)Algeria
- Analytical Expertise Center (AEM)Azerbaijan
- ANMATArgentina · Buenos Aires
- ANMDMR (National Agency for Medicines and Medical Devices of Romania)Romania
- ANSMFrance · Saint-Denis
- ANVISABrazil · Brasília
- ARCSAEcuador · Guayaquil
- BASG — Austrian Federal Office for Safety in Health CareAustria · Vienna
- BfArMGermany · Bonn
- Bulgarian Drug Agency (BDA)Bulgaria
- CCMO — Central Committee on Research Involving Human SubjectsNetherlands · The Hague
- CDSCOIndia · New Delhi
- CECMEDCuba · Havana
- COFEPRISMexico · Mexico City
- Danish Medicines Agency (DKMA)Denmark · Copenhagen
- Department of Drug Administration (DDA) NepalNepal · Kathmandu
- Department of Health – Abu Dhabi (DoH)United Arab Emirates · Abu Dhabi
- DIGEMIDPeru · Lima
- DINAVISAParaguay
- DRCPFA — Ministry of Public Health of GuatemalaGuatemala
- Drug Regulatory Authority of Pakistan (DRAP)Pakistan · Islamabad
- Dubai Health Authority (DHA)United Arab Emirates · Dubai
- Egyptian Drug Authority (EDA)Egypt
- Egyptian Nuclear and Radiological Regulatory Authority (ENRRA)Egypt · Cairo
- Emirates Drug Establishment (EDE)United Arab Emirates
- Energy and Minerals Regulatory Commission (EMRC)Jordan · Amman
- EOF (National Organisation for Medicines)Greece · Athens
- Ethiopian Food and Drug Authority (EFDA)Ethiopia · Addis Ababa
- European Commission — Medical DevicesBelgium · Brussels
- FAMHP — Federal Agency for Medicines and Health ProductsBelgium · Brussels
- Federal Authority for Nuclear Regulation (FANR)United Arab Emirates · Abu Dhabi
- Food and Drugs Authority (Ghana)Ghana
- HALMED (Agency for Medicinal Products and Medical Devices of Croatia)Croatia · Zagreb
- Health Canada — Medical Devices DirectorateCanada · Ottawa
- HPRAIreland · Dublin
- HSA SingaporeSingapore · Singapore
- Icelandic Medicines Agency (Lyfjastofnun)Iceland · Reykjavik
- IGJ — Health and Youth Care InspectorateNetherlands · Utrecht
- IMDRFGlobal
- INFARMEDPortugal
- Instituto de Salud Pública de Chile (ISP)Chile · Santiago
- Instituto Nacional de Higiene Rafael RangelVenezuela · Caracas
- INVIMAColombia · Bogotá
- JAZMP (Agency for Medicinal Products and Medical Devices of the Republic of Slovenia)Slovenia · Ljubljana
- Jordan Food and Drug Administration (JFDA)Jordan · Amman
- Luxembourg Ministry of Health and Social Security — Medical devicesLuxembourg · Luxembourg
- Malta Medicines Authority — Medical DevicesMalta · San Ġwann
- MDSAPGlobal
- Medical Device Authority (MDA) MalaysiaMalaysia · Cyberjaya
- Medical Device Division, Department of Health (Hong Kong)Hong Kong SAR China · Hong Kong
- Medicine and Medical Devices Regulatory Agency (Mongolia)Mongolia · Ulaanbaatar
- Medicines Control Authority of Zimbabwe (MCAZ)Zimbabwe · Harare
- MedsafeNew Zealand · Wellington
- MFDSSouth Korea · Cheongju
- MHRAUnited Kingdom · London
- Ministry of Health of Costa RicaCosta Rica · San José
- Ministry of Health of IraqIraq · Baghdad
- Ministry of Health of SyriaSyria · Damascus
- Ministry of Health Oman — Drug Safety CenterOman · Muscat
- Ministry of Public Health of LebanonLebanon · Beirut
- Ministry of Public Health of Uruguay — Technology EvaluationUruguay · Montevideo
- NAFDACNigeria · Abuja
- National Directorate of Medical Devices (MINSA Panama)Panama
- National Health Regulatory Authority (NHRA)Bahrain · Manama
- National Institute of Medical Device Safety Information (NIDS)South Korea · Seoul
- National Medicines and Poisons Board (NMPB)Sudan
- National Medicines Regulatory Authority (NMRA)Sri Lanka · Colombo
- NMPAChina · Beijing
- Norwegian Medical Products Agency (DMP)Norway · Oslo
- Palestinian Ministry of HealthPalestinian Territories · Ramallah
- Pharmacy and Medicines Regulatory Authority (PMRA)Malawi · Lilongwe
- Pharmacy and Poisons Board (Kenya)Kenya · Nairobi
- PMDAJapan · Tokyo
- RoszdravnadzorRussia · Moscow
- Rwanda Food and Drugs Authority (Rwanda FDA)Rwanda · Kigali
- SAHPRASouth Africa · Pretoria
- Saudi Food and Drug Authority (SFDA)Saudi Arabia · Riyadh
- Swedish Medical Products Agency (Läkemedelsverket)Sweden · Uppsala
- SwissmedicSwitzerland · Bern
- SÚKL (State Institute for Drug Control)Czechia
- Tanzania Medicines and Medical Devices Authority (TMDA)Tanzania · Dodoma
- TFDA TaiwanTaiwan · Taipei
- TGA (Therapeutic Goods Administration)Australia
- TİTCKTürkiye · Ankara
- UAE Ministry of Health and Prevention (MOHAP)United Arab Emirates · Dubai
- Ukrainian Pharmaceutical Agency (State Service of Ukraine on Medicines and Drugs Control)Ukraine · Kyiv
- US FDA — Center for Devices and Radiological Health (CDRH)United States · Silver Spring, MD
- Zambia Medicines Regulatory Authority (ZAMRA)Zambia · Lusaka
- ŠÚKL (State Institute for Drug Control, Slovakia)Slovakia · Bratislava
Standards (35)
- ABNTBrazil
- ANSI/AAMI EQ56 & EQ89 — HTM programmesUnited States · Arlington, VA
- Bureau of Indian Standards (BIS)India
- CEN-CENELECBelgium · Brussels
- Central Organization for Standardization and Quality Control (COSQC)Iraq · Baghdad
- DICOMGlobal
- Egyptian Organization for Standardization and Quality (EOS)Egypt
- GCC Standardization Organization (GSO)Saudi Arabia · Riyadh
- GMDNUnited Kingdom · Oxford
- GS1 Healthcare (UDI)Belgium · Brussels
- HL7 FHIRUnited States · Ann Arbor, MI
- IEC 60601 series — Medical electrical equipmentGlobal
- IEC 62304 — Medical device softwareGlobal
- IEC 62353 — Recurrent test and test after repairGlobal
- IEC 62366-1 — Usability engineeringGlobal
- IEC 80001-1 — IT networks with medical devicesGlobal
- IHE (Integrating the Healthcare Enterprise)Global
- INNORPITunisia · Tunis
- Institut Algérien de Normalisation (IANOR)Algeria · Algiers
- ISO 10993 series — Biological evaluationGlobal
- ISO 13485 — Quality management systemsGlobal
- ISO 14971 — Risk managementGlobal
- ISO 15223-1 — Symbols for labellingGlobal
- ISO/IEEE 11073 — Health device communicationGlobal
- Jordan Standards and Metrology Organization (JSMO)Jordan · Amman
- LIBNOR — Lebanese Standards InstitutionLebanon
- Libyan National Center for Standardization and Metrology (LNCSM)Libya · Tripoli
- Mongolian Agency for Standardization and Metrology (MASM)Mongolia · Ulaanbaatar
- NFPA 99 — Health Care Facilities CodeUnited States · Quincy, MA
- Palestinian Standards Institution (PSI)Palestinian Territories · Ramallah
- Saudi Standards, Metrology and Quality Organization (SASO)Saudi Arabia · Riyadh
- Standards AustraliaAustralia · Sydney
- Standards New ZealandNew Zealand
- Sudanese Standards and Metrology Organization (SSMO)Sudan · Khartoum
- Turkish Standards Institution (TSE)Türkiye · Ankara
Notified Bodies & Test Labs (31)
- 3EC InternationalSlovakia · Bratislava
- BSI GroupUnited Kingdom · London
- DEKRAGermany · Stuttgart
- DNVNorway · Høvik
- DQS MedizinprodukteGermany · Frankfurt
- EKAPTYGreece · Athens
- Eurofins Medical Device ServicesLuxembourg · Luxembourg
- GMEDFrance · Paris
- Hong Kong Standards and Testing Centre (STC)Hong Kong SAR China · Hong Kong
- Improve MedicalUkraine · Kyiv
- Industrial Research Institute (IRI)Lebanon · Hadat
- IntertekUnited Kingdom · London
- ITC — Institute for Testing and CertificationCzechia · Zlín
- Japan Quality Assurance Organization (JQA)Japan · Tokyo
- Korea Testing Laboratory (KTL)South Korea · Jinju
- mdc medical device certificationGermany · Stuttgart
- Nelson LabsUnited States · Salt Lake City, UT
- NemkoNorway · Lysaker
- NSAI (National Standards Authority of Ireland)Ireland · Dublin
- QMD ServicesAustria · Vienna
- SGSSwitzerland · Baar
- SIQ LjubljanaSlovenia · Ljubljana
- South African Bureau of Standards (SABS)South Africa
- SzutestTürkiye · Istanbul
- TÜV NORDGermany · Hanover
- TÜV RheinlandGermany · Cologne
- TÜV SÜDGermany · Munich
- UDEMTürkiye · Ankara
- UL SolutionsUnited States · Northbrook, IL
- UNI-CERT (Ukrainian Scientific Institute of Certification)Ukraine · Kyiv
- VNIIIMTRussia · Moscow
Consulting & CRO (13)
- ARQonSingapore · Singapore
- bioaccessUnited States · Miami, FL
- CliniExpertsIndia · New Delhi
- CratiaUkraine · Kyiv
- DecomplixSwitzerland · Bern
- Emergo by ULUnited States
- GBA Key2ComplianceSweden
- Johner InstitutGermany · Konstanz
- Morulaa HealthTechIndia
- NAMSAUnited States · Northwood, OH
- Operon StrategistIndia · Pune
- QbD GroupBelgium · Wilrijk
- Qserve GroupNetherlands · Arnhem
Databases & Registries (8)
- AccessGUDIDUnited States · Bethesda, MD
- ClinicalTrials.govUnited States · Bethesda, MD
- EUDAMEDBelgium · Brussels
- FDA 510(k) Premarket Notification databaseUnited States
- FDA MAUDEUnited States
- openFDAUnited States
- SFDA Licensed Establishments ListSaudi Arabia · Riyadh
- SFDA Medical Equipment ListSaudi Arabia · Riyadh
Regulations (3)
- EU IVDR — Regulation (EU) 2017/746Belgium · Brussels
- EU MDR — Regulation (EU) 2017/745Belgium · Brussels
- FDA QMSR — 21 CFR Part 820United States · Silver Spring, MD
Frequently asked questions
How many Regulatory & Standards listings are in The Biomedical Index?
As of 2026-11-13, The Biomedical Index lists 182 Regulatory & Standards listings from 83 countries. The largest types are Regulatory Authorities (92), Standards (35), Notified Bodies & Test Labs (31), Consulting & CRO (13) and Databases & Registries (8).
Which countries have the most Regulatory & Standards listings?
By number of listings: United States (15), Belgium (8), Germany (8), India (5) and Saudi Arabia (5).
What does the Regulatory & Standards category include?
Regulators, standards bodies and official guidance for medical devices.
How do I get listed in The Biomedical Index?
Use the Submit button on the directory at https://thebiomedicalindex.com/. Listing is free. Every submission is reviewed by hand before it goes live. Inclusion and order are not for sale.
Where does the information come from?
Listings are compiled from each organisation's official website and public materials. They are editorially reviewed, and organisations that fall under the site's editorial blocklist are not shown. Counts and pages are dated on each build. This build is dated 2026-11-13.