QMS for International Markets: MDSAP, 21 CFR 820, BGMP

The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device or IVD manufacturer’s quality management system to demonstrate compliance with the regulatory requirements of participating countries (USA, Canada, Japan, Australia, Brazil).

21 CFR 820, also known as the Quality System Regulation (QSR), outlines the Good Manufacturing Practices governing the methods, facilities, and controls required for the design, production, packaging, labelling, storage, installation, and servicing of all finished medical devices and IVDs intended for human use. These requirements ensure that medical devices are safe and effective. Manufacturers aiming to sell in the USA are subject to FDA inspections to verify compliance with 21 CFR 820.

Other country-specific requirements include, for example:

• Brazil: RDC 665/2022 establishes Quality Management System (QMS) requirements for manufacturers, importers, distributors, and retailers of medical devices and IVDs.

• Canada: MDSAP certification is mandatory for Class II or higher products.

Maytal can support manufacturers of medical devices and IVDs intending to export to MDSAP-participating countries such as the USA and Brazil by:

• Implementing a Quality Management System in compliance with MDSAP requirements, 21 CFR 820, or Brazilian BGMP (RDC 665/2022) regulations

• Conducting internal audits and supplier audits for critical outsourced processes

• Assisting the company during certification audits, including audits by MDSAP Auditing Organizations or competent authorities such as FDA (USA) and ANVISA (Brazil)