Access the Medical Devices Global Market – MDSAP
Medical Device Single Audit Program – MDSAP Audits and Certification
What is the Directive, Legislation or Standard?
Based on ISO 13485:2016 the MDSAP was developed by representatives of:
- Australian Therapeutic Goods Administration (TGA),
- Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA),
- Health Canada,
- MHLW/PMDA, and the
- U.S. Food and Drug Administration (FDA).
The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
Broader Market Access - As of May 2019, MDSAP opened the door for additional affiliate member – this means regulatory authorities that are not currently participating in the MDSAP but wish to engage in MDSAP and to utilize MDSAP audit reports for evaluating a medical device manufacturer’s quality management system.
What products are covered?
- Australia: The Therapeutic Goods Administration – TGA
- Where regulations do not require a manufacturer or product to hold a TGA Conformity Assessment Certificate;
- The TGA will take into account MDSAP- audit reports when considering whether a manufacturer has demonstrated compliance with an Australian Conformity Assessment procedure; or
- Where regulations require a manufacturer or product to hold a TGA Conformity Assessment Certificate;
- The TGA will take into account MDSAP audit reports when considering whether to issue or maintain a TGA Conformity Assessment Certificate.
- Brazil: The Brazilian National Health Surveillance Agency – ANVISA
- ANVISA utilizes the outcomes of the program, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures. As defined in RDC 15/2014 and RE 2.347/2015, ANVISA may use MDSAP audits in lieu of a premarket inspection by ANVISA to grant ANVISA’s GMP Certificate to manufacturers intending to put medical devices of class III or IV on the Brazilian market. Undergoing an MDSAP audit may accelerate ANVISA´s GMP certification process, which is a pre-requisite to the marketing authorization.
- ANVISA can also use MDSAP audits to renew ANVISA’s GMP Certificate bi-annually, as an alternative to an ANVISA comprehensive inspection.
- Japan: When an MDSAP audit report is submitted at the timing of premarket or periodical post-market QMS inspection application, Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the report as a trial:
- To exempt a manufacturing site etc.* from on-site inspection, and/or
- To allow a Marketing Authorization Holder (MAH) to substitute considerable part of documents required for the inspection with the report.
- Health Canada - Class II, III or IV medical device license, pursuant to section 32 of the Regulations.
- United States: U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, will accept the MDSAP audit reports as a substitute for FDA routine inspections (biennial by policy).
For further information see "Q31 What are the potential benefits to the manufacturer participating, specific to each jurisdiction?" from the following link.
Basic Technical Concepts
The MDSAP audit process was designed and developed not only to prevent duplication, but also to ensure that the program provides efficient and thorough coverage of the requirements of; Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) and any corresponding section(s) of the Australian Therapeutic Goods (Medical Devices) Regulations (SR 236, 2002), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Canadian Medical Device Regulations (CMDR, Part 1), the Japanese QMS ordinance (MHLW MO 169), the Quality System Regulation (21CFR 820), and other country-specific requirements.
The MDSAP audit sequence follows a process approach and was designed and developed to allow the audit to be conducted in a logical, focused, and efficient manner.
The MDSAP relies on:
Annual audits of manufacturers according to an audit model specific to the program. This audit model was developed to review the compliance of a manufacturer’s quality management system to the international standard ISO 13485 and additional regulatory requirements applicable to the countries where the devices are sold; and
Annual assessments of the Auditing Organizations’ management system compliance to the international standard ISO/IEC 17021-1 and MDSAP specific requirements as defined in IMDRF