Direct Links to important GMP Medical Device Guidelines

FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

This guidance document provides recommendations to manufacturers for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices.

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Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices

This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities, Conformity Assessment Bodies and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of IVD medical devices in the interest of public health.

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Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities, Conformity Assessment Bodies and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health.

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MEDDEV-Dokumente

Guidelines of Notified Bodies for Medical Devices

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Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

This guidance document is intended for medical device manufacturers and it is expected that the reader is familiar with regulatory quality management system requirements within the medical devices sector. This guidance document may also be useful to regulatory authorities and suppliers. This guidance document is intended for educational purposes and it is not intended to be used to assess or audit compliance with regulatory requirements.

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Definition of the Terms Manufacturer, Authorised Representative, Distributor and Importer

The objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical devices in order to facilitate trade whilst preserving the right of participating members to address the protection of public health by regulatory means considered to be most suitable.

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Clinical Evaluation

The primary purpose of this document is to provide manufacturers with guidance on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure prior to placing a medical device on the market as well as to support its ongoing marketing.

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Clinical Evidence

This document is the first produced by Study Group 5 and is intended to: • introduce the concepts of clinical evaluation and clinical evidence; • examine the relationship between clinical investigation, clinical data, clinical evaluation and clinical evidence; and • serve as guidance to all those involved in the generation, compilation and review of clinical evidence sufficient to support the marketing of medical devices (regulatory authorities, conformity assessment bodies, manufacturers of medical devices and their associated industry groups).

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Guidelines for Regulatory Auditing of Quality Management Systems of Medical DeviceManufacturers Part 3: Regulatory Audit Report

This document gives guidance to regulators, auditing organizations and auditors on the content of audit reports. However, it may also help the auditee understand and respond to the audit findings.

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Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 4: Multiple Site Auditing

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers with multiple sites. This document should be read in conjunction with the Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers -- Part 2: Regulatory Auditing Strategy (GHTF/SG4/N30).

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GMP Conferences by Topics

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