December 15, 2020
UL’s Medical Devices Single Audit Program (MDSAP) helps manufacturers meet the quality management system (QMS) requirements for participating countries with a single QMS audit. MDSAP is based on International Medical Device Regulators Forum (IMDRF) quality system recommendations, and regulators currently participating in the program include the U.S. FDA, Health Canada, the Australian Therapeutic Goods Administration (TGA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Brazil’s National Health Surveillance Agency (ANVISA).
MDSAP Benefits for Medical Device Manufacturers
For the medical device industry, MDSAP is expected to significantly reduce the audit compliance challenges and timeframes. Specific benefits of MDSAP include:
Harmonization of auditing requirements
- Broader acceptance of audit reports among participating regulators
- Reduced overall auditing time and expense
- Reduced time responding to findings
- Wider choice of third-party audit organizations
- More transparent and consistent oversight by regulators
Similar to other management system audit programs, MDSAP is based on a three-year audit cycle conducted in accordance with the requirements of ISO/IEC 17021:
- Stage 1 Initial certification audit – Review of documentation and overall preparedness. Typically includes a review of the planning documentation.
- Stage 2 Initial certification audit – Evaluate QMS compliance to ISO 13485, as well as other requirements of MDSAP-participating regulatory authorities.
- Surveillance audits – Surveillance audit is conducted annually to also assess any changes in the manufacturer’s products or QMS processes since the initial certification audit.
- Recertification audit – In the third year to evaluate a manufacturer’s QMS for its continued suitability and effectiveness in meeting QMS requirements under MDSAP.