Direct Links to important GMP Medical Device Guidelines

Charge & Mission Statement

The purpose of the guidance is to improve the protection of the health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times.

Process Validation Guidance

This process validation guidance is intended to assist manufacturers in understanding quality system requirements concerning process validation.The guidance is revised due to the changes in ISO 13485:2003.

Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7)

This document has been written to provide assistance in the application of the 'Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General requirements’ and should be read in conjunction with that document.

Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers –Part 1: General Requirements

This document provides guidelines for auditing organisations responsible for establishing, planning, carrying out and documenting audits of quality systems to address regulatory requirements for manufacturers of medical devices.

Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies

21 CFR Part 26 Mutual recognition of pharmaceutical good manufacturing practice reports, and certain medical device product evaluation reports: US and the EC

Text of the Mutual Recognition Agreement, signed by the United States and the European Community in May, 1998. The proceedings are discontinued at the moment!

DECISION No 1/2017 OF THE COMMITTEE ESTABLISHED UNDER THE AGREEMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS CONFEDERATION ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT

amendment of Chapter 4 on medical devices, Chapter 6 on pressure vessels, Chapter 7 on radio equipment and elecommunication terminal equipment, Chapter 8 on equipment and protective systems intended for use in potentially explosive atmosphere, Chapter 9 on electrical equipment and electromagnetic compatibility, Chapter 11 on measuring instruments, Chapter 15 on medicinal products, GMP inspection and batch certification, Chapter 17 on lifts, and Chapter 20 on explosives for civil use, and the update of legal references listed in Annex 1 [2017/2118] THE COMMITTEE,

INSPECTION OF MEDICAL DEVICE MANUFACTURERS

The goal of this program is to advance and continually improve the quality, safety, and effectiveness of medical devices to meet patient needs.

Personalized Medical Devices – Production Verification and Validation

The purpose of this IMDRF guidance is to provide harmonized recommendations for verification and validation aspects of a patient-matched medical device and a medical device production system (MDPS).

FDA Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, June 1, 2004

This guidance document describes the types of validation data that FDA recommends be submitted under section 510(o) of the Act. In addition, it provides guidance to industry and FDA staff on how the agency will implement this new section with respect to the submission of validation data in 510(k)s for reprocessed Single Used Devices

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