What is MDSAP and where does it apply?
The intent of the Medical Devices Single Audit Program’s (MDSAP) is to allow manufacturers to meet the quality management system (QMS) for participating countries with a single QMS audit. The program is based on the International Medical Device Regulators Forum (IMDRF) program documentation and countries that are currently participating are: U.S. FDA, Health Canada, Australia Therapeutic Goods Administration (TGA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), and Brazil National Health Surveillance Agency (ANVISA).
The MDSAP Benefits for Device Manufacturers
For the medical device industry, the MDSAP is expected to significantly reduce the audit compliance challenges facing device manufacturers. Specific benefits of the MDSAP include:
- Harmonization of auditing requirements
- Broader acceptance of audit reports
- Reduced overall auditing time and expense
- Reduced time responding to findings
- Wider choice of 3rd party audit organizations
- More transparent and consistent oversight by regulators
Similar to other management system audit programs, the 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 the MDSAP.
UL utilizes in-house auditors so you have a consistent experience and benefit of years of expertise in the medical field.
- UL medical quality system auditors have experience and educational backgrounds in medical devices, so you have less time “training” the auditor in the complexities of the medical industry.
- UL auditors are located in the major medical markets around the world, reducing travel time and increasing the ability to communicate real time in the local language.
- UL is a Recognized Auditing Organization (AO) under the MDSAP, and can provide medical device manufacturers with QMS pre- and post-market auditing services in all MDSAP jurisdictions.
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**As a Notified Body, MDSAP Recognized Auditing Organization and ISO 17000 series accredited Certification Body we cannot participate in the design, manufacture, installation or distribution of the products we certify or provide consultancy services related to those products. In addition, the UL Notified Body cannot provide certification services to companies that have been provided with consultancy services from other companies in the UL family. We also cannot link our activities to the activities of organizations that provide consultancy services. If you require such services please use an internet search engine to identify relevant providers.