Medical Device Single Audit Program (MDSAP)

Overview

Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single audit program instead of multiple audits from different countries. It is a global program and furnishes relevant Regulatory requirements for five countries, i.e., Brazil (ANVISA), USA (FDA), Japan (PMDA), Canada (Health Canada), and Australia (TGA). Besides the participating Regulatory Authorities, several other international partners (the official observers and affiliate members) are involved in the MDSAP.

MDSAP certification is mandated by Health Canada for Class II, III, and IV devices but is voluntary for the other four (04) countries. It has promoted transparency and Regulatory alignment between participating authorities and minimized the need for multiple audits, thus saving time and resources for medical device manufacturers.

Navigate through the Frequently Asked Questions (FAQs) about the MDSAP program.

The MDSAP audit process is conducted by an Auditing Organization (AO) authorized by the participating Regulatory Authorities. The AO will conduct an on-site audit of the manufacturer's QMS and evaluate the manufacturer's compliance with the MDSAP requirements. The audit is based on QMS requirements as per ISO 13485:2016 and Regulatory requirements of the participating country where the medical devices will be marketed.

The MDSAP is based on a three (03) year audit cycle. The MDSAP audit cycle comprises of:

• Initial certification audit that consists of Stage 1 and Stage 2 audits to review documentation and determine if all ISO 13485 and Regulatory requirements are met. After the successful completion of Stage 2, the MDSAP certificate is issued by the AO
• Partial surveillance audits in each of the following two (02) years
• Re-audit or Re-certification audit, which is conducted every three (03) years to confirm the continued applicability of the organizations’ QMS

Manufacturers that successfully pass the MDSAP audit will receive a certificate of compliance, which will be recognized by the Regulatory Authorities of participating countries. So manufacturers can sell their devices in multiple global markets without additional audits. MDSAP certification establishes conformity to the country-specific requirements. However, the devices still need registration with the Health Agency to be placed in the market.

Freyr’s MDSAP Regulatory consulting services can help you navigate the complex Regulatory landscape and ensure that your medical devices meet the requirements of the MDSAP program. Our team of experts has extensive experience in the medical device industry and a deep understanding of the MDSAP regulations.