This page provides popular links to regulations, guidance documents and databases for the following regulatory bodies, ordered as shown:

FDA – United States

FDA Medical Device Regulations/Acts:

Affordable Care Act

CDRH Management Directory by Organization

Code of Federal Regulations (electronic) – Title 21 CFR – Food and Drugs

Quality System Regulation and Preamble (QSR)

FDA IVD Resources:

Clinical Laboratory Improvement Amendments (CLIA) 

FDA Guidance: In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions

FDA Guidance: Design Considerations for Devices Intended for Home Use 


FDA Medical Device Guidance Documents:

Submission-Related Guidances

510(k) Substantial equivalence – The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], July 2014 

510(k) Third Party Review Program, March 2020

513(g) – FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act, December 2019 

Abbreviated 510(k) - How to Prepare an Abbreviated 510(k)

Benefit-Risk – Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2018 

Deciding When to Submit a 510(k) for a Change to an Existing Device: Oct 2017

Deciding When to Submit a 510(k) for a Software Change to an Existing Device

De Novo - De Novo Classification Process (Evaluation of Automatic Class III Designation) Guidance for Industry and Food and Drug Administration Staff 

Emergency Use Authorization (EUA)

IDEs – Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

Medical Device User Fees

Pre-market Approval (PMA)

Refuse to Accept Policy for 510(k)s, Sep 2019

Special 510(k) Program, Sep 2019

Software – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005 

Traditional 510(k) - How to Prepare a Traditional 510(k)

Q-Sub – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, January 2021 

Other Popular FDA Guidance Documents:

Acceptance of Clinical Data to Support Medical Device Applications and Submissions – Frequently Asked Questions 

Applying Human Factors and Usability Engineering to Medical Devices, February 2016 

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices 

Biocompatibility - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

Biocompatibility - Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin

Breakthrough Devices Program

Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, January 2005

Design Control Guidance for Medical Device Manufacturers

PMA Guidance Documents List 

Recognized Consensus Standards 

Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions 

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

RWE - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, August 2017

Shelf Life of Medical Devices

SteP: Safer Technologies Program (SteP) for Medical Devices, January 2021

European Commission – EU

Regulations and Standards:

EU MDR Consolidated Text: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

EU IVDR Consolidated Text: Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

Harmonized Standards

Unique Device Identification (UDI) Helpdesk 

Regulators and NBs:

Competent Authorities for Medical Devices (CAMD)

European Commission – Medical Devices Sector: Overview

Global Harmonization Task Force Archive (GHTF)

International Medical Device Regulators Form (IMDRF)

Team NB – The European Association for Medical Devices of Notified Bodies


MEDDEV – Europa list of Guidance MEDDEV’s with links

MEDDEV 2.7/1 Rev 4 – Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42 and 90/385

Medical Device Coordination Group (MDCG):

MDCG endorsed documents and other guidance applying MDR and IVDR – list with links

MDCG 2019 – Summary of safety and clinical performance: A guide for manufacturers and notified bodies

MDCG 2020-5 – Clinical Evaluation – Equivalence: A guide for manufacturers and notified bodies

MDCG 2020-6 – Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC: A guide for manufacturers and notified bodies

MDCG 2020-7 – Post-market clinical follow-up (PMCF) Plan Template

A guide for manufacturers and notified bodies

MDCG 2020-8 – Post-market clinical follow-up (PMCF) Evaluation Report Template: A guide for manufacturers and notified bodies

MDCG 2020-13 – Clinical evaluation assessment report template

MDCG 2021-6 – Regulation (EU) 2017/745: Questions & Answers regarding clinical investigation

Health Canada – Canada

Health Canada

Food and Drugs Act (R.S.C., 1985, c. F-27)

Health Canada Guidance Document –Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices (IVDDs) 

Health Canada Guidance Document – Labelling of In Vitro Diagnostic Devices 

Medical Devices – General Information

Medical Devices Active Licences Search;jsessionid=0137A99CAA05EB180702F4F24B1132B1?type=active

Medical Device Application Forms

Medical Device Application Guidance Document - How to Complete the Application for a New Medical Device Licence

Post-Market Summary Reports – Guidance on summary reports and issue-related analyses for medical devices: Overview

PMDA – Japan

Pharmaceuticals and Medical Devices Agency (PMDA)

Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD) Act No. 145 of August 10, 1960

Quality Management System Requirements Stipulated in MHLW Ministerial Ordinance No. 169

Frequently Asked Questions (In English)

National Medical Products Administrations – China

National Medical Products Administration

Medical Devices

Provisions for Medical Device Registration (Decree No. 4 of China Food and Drug Administration)

ANVISA – Brazil

Brazilian Health Regulatory Agency (Anvisa)

Medical devices

TGA – Australia

Therapeutic Goods Administration

Regulation Basics

Information for Industry

Medical Devices and IVDs

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