Regulatory Directory

Official health authorities and key technical resources for medical device, IVD and pharmaceutical compliance. Links checked October 26, 2026. Standards may require purchase; agency scopes vary by country.

85 results

• FDA and U.S. regulations

  FDA Medical Devices

  Device regulation, market submissions, safety and compliance.

  Regulator · Free

• FDA and U.S. regulations

  FDA Drugs

  Human drug development, approvals, manufacturing and safety.

  Regulator · Free

• FDA and U.S. regulations

  FDA In Vitro Diagnostics

  IVD regulatory information and related guidance.

  Regulator · Free

• FDA and U.S. regulations

  FDA QMSR

  FDA quality management system requirements for medical devices.

  Regulator · Free

• FDA and U.S. regulations

  FDA Guidance Search

  Search FDA guidance by product, topic or document title.

  Regulator · Free

• FDA and U.S. regulations

  21 CFR Part 11

  Electronic records and electronic signatures.

  Law / regulation · Free

• FDA and U.S. regulations

  21 CFR Part 809

  In vitro diagnostic products for human use.

  Law / regulation · Free

• FDA and U.S. regulations

  21 CFR Part 820 (QMSR)

  Current medical device quality management system regulation.

  Law / regulation · Free

• FDA and U.S. regulations

  21 CFR Parts 210 and 211

  Pharmaceutical CGMP regulations; navigate to Parts 210 and 211.

  Law / regulation · Free

• FDA and U.S. regulations

  AccessGUDID

  Search the U.S. public unique device identification database.

  Government database · Free

• FDA and U.S. regulations

  Drugs@FDA

  Search FDA-approved drugs and approval documents.

  Regulator / database · Free

• FDA and U.S. regulations

  FDA Device Advice

  Practical device regulation and submission resources.

  Regulator · Free

• FDA and U.S. regulations

  FDA Drug CGMP Resources

  Pharmaceutical current good manufacturing practice resources.

  Regulator · Free

• FDA and U.S. regulations

  FDA Medical Device Databases

  510(k), PMA, classification, MAUDE and other device databases.

  Regulator / databases · Free

• FDA and U.S. regulations

  FDA Orange Book

  Approved drug products and therapeutic equivalence evaluations.

  Regulator / database · Free

• FDA and U.S. regulations

  FDA Purple Book

  Licensed biological products and biosimilarity/interchangeability information.

  Regulator / database · Free

• FDA and U.S. regulations

  FDA Recalls and Safety Alerts

  Product recalls, market withdrawals and safety alerts.

  Regulator · Free

• FDA and U.S. regulations

  FDA Recognized Consensus Standards

  Check recognized editions, extent of recognition and transition dates.

  Regulator / database · Free

• FDA and U.S. regulations

  FDA Vaccines, Blood and Biologics

  Biological products and CBER resources.

  Regulator · Free

• FDA and U.S. regulations

  FDA Warning Letters

  Inspection and compliance enforcement correspondence.

  Regulator · Free

• FDA and U.S. regulations

  Federal Register

  FDA rulemaking, proposed rules and notices.

  Government publication · Free

• EU, UK and EUDAMED

  EUDAMED Public Database

  Public access to the European Database on Medical Devices.

  Regulator / database · Free

• EU, UK and EUDAMED

  EUDAMED Information and Support

  Modules, implementation, user documentation and support resources.

  Regulator · Free

• EU, UK and EUDAMED

  Clinical Trials Information System (CTIS)

  EU clinical trial information and public search.

  Official database · Free

• EU, UK and EUDAMED

  EU Harmonised Standards for Medical Devices

  References supporting presumption of conformity under EU legislation.

  Regulatory standards references · Free

• EU, UK and EUDAMED

  EU IVDR (Regulation 2017/746)

  Official IVDR text; select the current consolidated version in EUR-Lex.

  Law / regulation · Free

• EU, UK and EUDAMED

  EU MDR (Regulation 2017/745)

  Official MDR text; select the current consolidated version in EUR-Lex.

  Law / regulation · Free

• EU, UK and EUDAMED

  EU Medical Device Competent Authorities

  National medical device and IVD authority contact lists.

  Official directory · Free

• EU, UK and EUDAMED

  EudraGMDP

  EU manufacturing/import authorisations and GMP/GDP information.

  Official database · Free

• EU, UK and EUDAMED

  EudraLex Volume 4 (EU GMP)

  EU GMP guidelines, including Annex 1 for sterile medicinal products.

  Regulatory guidance · Free

• EU, UK and EUDAMED

  European Commission Medical Devices Sector

  EU medical device and IVD policy, implementation and updates.

  Regulator / policy · Free

• EU, UK and EUDAMED

  European Medicines Agency (EMA)

  Medicines regulation, scientific guidelines and product information.

  Regulator · Free

• EU, UK and EUDAMED

  MDCG Guidance Documents

  EU guidance on MDR, IVDR, classification, UDI and conformity assessment.

  Regulatory guidance · Free

• EU, UK and EUDAMED

  MHRA

  UK medical device and medicines regulation.

  Regulator · Free

• EU, UK and EUDAMED

  NANDO / Notified Bodies

  Check notified body designations and scope.

  Official designation database · Free

• Sterilization and sterile packaging

  FDA Sterilization for Medical Devices

  Medical device EO, radiation and other sterilization resources.

  Regulator · Free

• Sterilization and sterile packaging

  ISO 11135 (EO sterilization)

  EO process development, validation and routine control.

  Standards publisher · Paid standard / free abstract

• Sterilization and sterile packaging

  ISO 11137 Radiation Sterilization Package

  Radiation sterilization, including gamma, electron beam and X-ray processes.

  Standards publisher · Paid standards / free overview

• Sterilization and sterile packaging

  AAMI Standards and Technical Information Reports

  Sterilization, microbiology, packaging and medical technology standards.

  Standards organization · Mixed

• Sterilization and sterile packaging

  ASTM International

  Packaging, seal strength, integrity, aging and radiation dosimetry standards.

  Standards organization · Mixed

• Sterilization and sterile packaging

  CDC Disinfection and Sterilization

  Healthcare-facility disinfection and sterilization guidance.

  Public health guidance · Free

• Sterilization and sterile packaging

  EPA Commercial Sterilizers

  U.S. air-emission requirements affecting EO sterilization facilities.

  Environmental regulator · Free

• Sterilization and sterile packaging

  FDA Sterility Information for 510(k)s

  Sterility information for devices labeled sterile.

  Regulatory guidance · Free

• Sterilization and sterile packaging

  IAEA Medical Sterilization Using Radiation

  Technical information on radiation processing and applications.

  Intergovernmental technical resource · Free

• Sterilization and sterile packaging

  International Irradiation Association (iia)

  Industrial radiation processing and sterilization education.

  Industry association · Mixed

• Sterilization and sterile packaging

  ISO 10993-7 (EO residuals)

  Biological evaluation requirements for EO sterilization residuals.

  Standards publisher · Paid standards / free abstract

• Sterilization and sterile packaging

  ISO 11138-1 (Biological indicators)

  General requirements for biological indicators used in sterilization.

  Standards publisher · Paid standards / free abstract

• Sterilization and sterile packaging

  ISO 11138-7 (BI selection and use)

  Selection, use and interpretation of biological indicators.

  Standards publisher · Paid standards / free abstract

• Sterilization and sterile packaging

  ISO 11607-1 (Sterile barrier packaging)

  Materials, sterile barrier systems and packaging systems.

  Standards publisher · Paid standards / free abstract

• Sterilization and sterile packaging

  ISO 11607-2 (Packaging process validation)

  Validation of forming, sealing and assembly processes.

  Standards publisher · Paid standards / free abstract

• Sterilization and sterile packaging

  ISO 11737-1 (Bioburden)

  Determining the microbial population on health care products.

  Standards publisher · Paid standards / free abstract

• Sterilization and sterile packaging

  ISO 11737-2 (Sterility tests in validation)

  Sterility tests used to define, validate and maintain sterilization processes.

  Standards publisher · Paid standards / free abstract

• Sterilization and sterile packaging

  ISO 14937 (General sterilization requirements)

  Sterilizing-agent characterization and process development, validation and control.

  Standards publisher · Paid standard / free abstract

• Sterilization and sterile packaging

  OSHA Ethylene Oxide

  Worker exposure, safety standards and EO resources.

  Occupational safety regulator · Free

• Standards and quality systems

  ANSI

  U.S. standards coordination, accreditation and standards information.

  Standards organization · Mixed

• Standards and quality systems

  ANSI Webstore

  Licensed access to ANSI, ISO, IEC and other standards.

  Standards seller · Paid standards / free search

• Standards and quality systems

  ISO

  International standards catalogue and publication status.

  Standards organization · Paid standards / free search

• Standards and quality systems

  EDQM / European Pharmacopoeia

  European Pharmacopoeia and quality-of-medicines resources.

  Pharmacopoeia / standards · Mixed

• Standards and quality systems

  IEC Webstore

  Electrical safety, software and medical electrical equipment standards.

  Standards organization · Paid standards / free search

• Standards and quality systems

  ISO 13485

  Quality management systems for medical devices.

  Standards publisher · Paid standard / free abstract

• Standards and quality systems

  ISO 14971

  Risk management for medical devices.

  Standards publisher · Paid standard / free abstract

• Standards and quality systems

  USP

  Pharmaceutical quality standards and compendial resources.

  Pharmacopoeia / standards · Mixed

• IVD and laboratory resources

  CLSI

  Clinical laboratory and diagnostic performance standards.

  Standards organization · Mixed

• IVD and laboratory resources

  ISO 15189 (Medical laboratories)

  Medical laboratory quality and competence.

  Standards publisher · Paid standards / free abstract

• IVD and laboratory resources

  ISO 18113-1 (IVD labeling)

  General requirements and terminology for manufacturer-supplied IVD information.

  Standards publisher · Paid standards / free abstract

• IVD and laboratory resources

  ISO 20916 (IVD clinical performance studies)

  Good study practice for IVD clinical performance studies.

  Standards publisher · Paid standards / free abstract

• IVD and laboratory resources

  ISO 23640 (IVD reagent stability)

  Evaluation of stability of IVD reagents.

  Standards publisher · Paid standards / free abstract

• IVD and laboratory resources

  ISO/TC 212 Published Standards

  Catalogue for medical laboratories and in vitro diagnostic systems.

  Standards publisher · Free catalogue

• Professional organizations

  RAPS

  Regulatory affairs education, certification and professional resources.

  Professional association · Mixed

• Professional organizations

  ASQ

  Quality management, auditing, training and certification resources.

  Professional association · Mixed

• Professional organizations

  ISPE

  Pharmaceutical engineering, manufacturing and GMP resources.

  Professional association · Mixed

• Professional organizations

  Parenteral Drug Association (PDA)

  Sterile pharmaceutical manufacturing, microbiology and technical education.

  Professional association · Mixed

• Professional organizations

  RAPS Regulatory Focus

  Regulatory news and analysis.

  Professional publication · Mixed

• Professional organizations

  TOPRA

  Regulatory affairs education and professional development.

  Professional association · Mixed

• Global harmonization and regulatory systems

  EMA National Competent Authorities

  EU and EEA national medicines authorities.

  Official directory · Free

• Global harmonization and regulatory systems

  GMDN Agency

  Global Medical Device Nomenclature resources.

  Nomenclature organization · Account required / mixed

• Global harmonization and regulatory systems

  GS1 Healthcare

  UDI, identification and supply-chain standards.

  Standards organization · Mixed

• Global harmonization and regulatory systems

  ICH

  Harmonized pharmaceutical quality, safety, efficacy and multidisciplinary guidelines.

  Regulatory harmonization · Free

• Global harmonization and regulatory systems

  ICMRA Participating Authorities

  Official participating medicines authority websites.

  Official directory · Free

• Global harmonization and regulatory systems

  ILAC

  Laboratory accreditation and recognition arrangement resources.

  Accreditation cooperation · Free

• Global harmonization and regulatory systems

  IMDRF

  International medical device harmonization documents and initiatives.

  Regulatory forum · Free

• Global harmonization and regulatory systems

  MDSAP

  Medical Device Single Audit Program and audit approach resources.

  Regulatory audit program · Free

• Global harmonization and regulatory systems

  PIC/S

  Pharmaceutical inspectorate cooperation and GMP guidance.

  Regulatory cooperation · Free

• Global harmonization and regulatory systems

  WHO Prequalification

  Prequalification resources for medicines, IVDs and other health products.

  WHO program · Free

• Global harmonization and regulatory systems

  WHO Regulatory Authority Contacts

  Medicines regulatory contact directory; check individual update dates.

  Official directory · Free