What is MDSAP?
The MDSAP allows a recognized Auditing Organization (AO) to conduct a single regulatory audit of a medical device manufacturer that satisfies the requirements of the following regulatory authorities (RAs):
- Australia’s Therapeutic Goods Administration (TGA)
- Brazilian Health Regulatory Agency (ANVISA)
- Health Canada (HC)
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
- U.S. Food and Drug Administration (USFDA)
These five RAs form the MDSAP Regulatory Authority Council (RAC), the decision-making body of the MDSAP. The RAC provides direction, oversight, and resources to support the MDSAP development, implementation, maintenance, and expansion.
Vision
Our vision for MDSAP is to ensure the highest standards of safety for medical devices, whilst minimizing regulatory burden through use of an agreed single audit process. The MDSAP Regulatory Authorities are committed to protecting patient health and wellbeing by continuously improving our audit methodologies, fostering transparency, and upholding the integrity of medical device safety.
In addition to MDSAP RAC Members, many other RAs utilize MDSAP to access the benefits the program provides. RAs who formally participate in MDSAP as Official Observers and Affiliate Members are listed below. If your regulatory organization recognizes or uses MDSAP, you may wish to contact us to add your information to this website, so manufacturers are aware of your acceptance.
MDSAP Official Observers
- European Union (EU) Competent Authorities, as represented by the European Commission DG for Health & Food Safety (DG SANTE)
- Singapore's Health Sciences Authority (HSA)
- United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)
- The World Health Organization’s (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme
MDSAP Affiliate Members
- Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT)
- Israel’s Ministry of Health
- Kenya's Pharmacy and Poisons Board
- Republic of Korea's Ministry of Food and Drug Safety
- Mexico’s Federal Commission for Protection from Sanitary Risks (COFEPRIS)
- Taiwan Food and Drug Administration (TFDA)
- South African Health Products Regulatory Authority
Further information on types of MDSAP Membership is available here.
MDSAP Overview
The program is based on ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes, with additional guidance provided to AOs on specific RA needs. In accordance with best practices, the MDSAP incorporates a transparent assessment program to oversee the compliance of AOs with MDSAP requirements and ensures appropriate competency and training of RA assessors who undertake the AO recognition process.
These requirements include, but are not limited to:
- IMDRF/MDSAP WG/N6 – Regulatory Authority Assessor Competence and Training Requirements
- IMDRF MDSAP WG/N3 – Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition
- IMDRF MDSAP WG/N4 – Competence and Training Requirements for Auditing Organizations
- IMDRF MDSAP WG/N11 - MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization.
At the conclusion of an MDSAP audit, a standardized MDSAP Audit Report is completed that ensures the reporting requirements of all participating RAs are effectively documented. After the successful closure of an audit, the AO will issue a MDSAP certificate to the medical device manufacturer. These certificates are used by many RAs globally and can be verified by reaching out to directly to the issuing MDSAP AO. Further information on these processes is available at Audit Approach and AO Assessment.
Not all MDSAP RAs consider MDSAP audit reports and certificates an alternative to the inspection and assessment requirements for combination products. Further information on audit requirements for these products is available here.