Medical Device Single Audit Program (MDSAP) （英語）

ACHIEVE ACCESS TO MULTIPLE MARKETS WITH A SINGLE AUDIT

The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organisations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements are applicable to regulatory authorities, as well as third-party organisations that conduct such audits.

WHAT IS THE MDSAP?

The objective of MDSAP is to develop, manage, and oversee a single audit program that allows a single regulatory audit of a Medical Device manufacturer, conducted by an MDSAP recognised auditing organisation, to satisfy the needs of multiple regulatory jurisdictions.

The participating regulatory authorities hope to achieve more consistency among the auditing organisations.

By following the MDSAP Audit Approach:

• Audits performed under MDSAP will be conducted in a consistent manner across auditing organisations.
• Audits will be conducted logically and efficiently, with attention to the interactions between processes.
• Auditors will be able to determine whether systemic quality management system nonconformities are present.

PARTICIPATING COUNTRIES

MDSAP includes 5 participating regulatory authorities:

1. Therapeutic Goods Administration of Australia (TGA)
2. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
3. Health Canada (HC)
4. Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW and PMDA)
5. U.S. Food and Drug Administration (FDA)

In addition, there are several observers and affiliate members of the program including:  

MDSAP Official Observers:

• European Union (EU)
• United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)
• The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Program

MDSAP Affiliate Members:

• Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT)
• Republic of Korea's Ministry of Food and Drug Safety
• Singapore's Health Sciences Authority (HSA)

HOW is MDSAP used by each PARTICIPATING REGULATORy Agency?

Australian Therapeutic Goods Administration (TGA)
TGA uses the MDSAP audit report as part of the evidence that is assessed in compliance with Medical Device market authorisation requirements, unless the Medical Device is otherwise excluded or exempted from these requirements, or if current policy restricts the use of MDSAP audit reports.

The Brazilian National Health Surveillance Agency ANVISA (Agência Nacional de Vigilância Sanitária)
ANVISA utilizes the outcomes of the program, including the reports, as input to ANVISA’s pre-market and post-market assessment procedures, by providing, when applicable, key information that is expected to support the regulatory technical evaluation on these issues.

Health Canada (HC)
Manufacturers of medical devices in classes II, III or IV wishing to apply for or maintain a Medical Device Licence must demonstrate that their products are in compliance with the requirements of the Canadian Medical Devices Regulation (CMDR SOR/98-282). In addition, the manufacturer’s quality management system is required to be certified according to ISO 13485. By issuing an MDSAP certificate, we confirm that the manufacturer's quality management system is in conformity with ISO 13485 as well as Canadian Medical Device Regulations.

US Food and Drug Administration, Center for Devices and Radiological Health (CDRH)
FDA accepts the MDSAP audit reports as a substitute for FDA routine inspections. Inspections conducted “for cause” or “compliance follow-up” by FDA are not affected by the program. Moreover, MDSAP does not apply to any necessary pre-approval or post-approval inspections for the Pre Market Approval (PMA) applications.

Japan Ministry of Health, Labor and Welfare
Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) uses the MDSAP audit report as a trial:
1) To exempt a manufacturing site etc.* from on-site inspection, and/or
2) To allow a Marketing Authorization Holder (MAH) to substitute considerable part of documents required for the inspection with the report.

*Exceptions:

a) A Registered Manufacturing Site (RMS) which manufactures medical devices made of human/animal tissues,

b) A RMS which manufactures radioactive IVDs, and

c) An establishment of a MAH.

PROGRAM ELIGIBILITY

• Any manufacturer may participate if a product falls under the scope of at least one participating Regulatory Authority and will be subject to their quality management system requirements.
• Manufacturers located anywhere in the world are eligible to participate.
• Only the MDSAP participating countries will have direct access to the audit reports.
• Manufacturers need to follow the audit approach. However, if the company does note its product in an MDSAP participating country, it is not obligated to adhere to that country’s specific requirements within the audit approach. The excluded country shall not appear on the MDSAP certificate scope. (This applies to the current 5 participating countries only - Australia, Brazil, Canada, US and Japan)

Note: Regulators witness some audits. This is for the evaluation of the Auditing Organisation, not the manufacturer. 

HOW CAN TÜV SÜD SUPPORT YOU?

TÜV SÜD is authorised to work with clients who would like to participate in MDSAP. If you are interested in the audit program, please fill up the form below.

Apply for MDSAP

As one of the leading Certification Body in the medical device industry, TÜV SÜD takes a proactive approach in informing our customers about the regulatory changes concerning the industry. Follow us on TÜV SÜD’s Medical Device LinkedIn Showcase page to keep up to date with the latest developments concerning MDSAP.

YOUR BENEFITS AT A GLANCE

• Continued accessibility in the Canadian market - Since January 1, 2019, manufacturers must have a MDSAP certificate if they want to apply for or maintain medical device licenses.
• Save time and money - by gaining access to multiple markets with a single audit program that satisfies the needs of multiple regulatory authorities.
• Reduce FDA routine inspections - and minimise manufacturing plant and personnel disruptions.

• Faster market access in Brazil - The MDSAP helps you to demonstrate that your devices are in compliance with the quality management and regulatory requirements which are applicable to place your device on the market in Brazil. Many manufacturers must wait up to one year, in certain cases even longer for inspection by the Brazilian registration authority, ANVISA. Except for some high-risk products, ANVISA accepts the MDSAP certification audit report as basis for preparation of a BGMP (Brazilian Good Manufacturing Practice) certificate, which you need to register your class III and class IV medical devices in Brazil.