What is the MDSAP?
Recognising that a global approach to assuring the safety of medical device manufacturing would provide tremendous benefit to the industry and the end user, the International Medical Device Regulators Forum (IMDRF) has created a harmonised approach to auditing and monitoring the manufacturing of medical devices. This approach is designed with the aim of improving medical device safety, as well as oversight of medical device manufacturing on an international scale. As a result, the Medical Device Single Audit Program (MDSAP) was established.
MDSAP allows medical device manufacturers to have a single audit of their Quality Management System (QMS) which satisfies the requirements of multiple regulatory jurisdictions.
Transition from CMDCAS to MDSAP
In 2015, Health Canada confirmed MDSAP would replace the Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. The implementation began at the conclusion of the MDSAP Pilot on 1 January 2017, and a period of two years commenced. During this two-year period, Health Canada accepts certificates issued under both CMDCAS and MDSAP, and works closely with CMDCAS certification holders to support their transition to the MDSAP.
The MDSAP audit cycle can be synchronised with the CMDCAS audit cycle. Medical device manufacturer should make this decision according to their regulatory and business interests. Medical device manufacturers who decide their first MDSAP audit to be their surveillance audit, will not obtain an MDSAP certificate until the recertification audit is conducted. Also, a regulatory authority may not be able to use a surveillance audit report during their process to issue a marketing authorisation.
Regulatory Authorities included in MDSAP
MDSAP allows medical device manufacturers to be audited once for compliance with the standard and regulatory requirements of five different medical device markets. The following five Regulatory Authorities are involved with MDSAP:
- Australia: The Therapeutics Goods Administration
- Brazil: The Brazilian National Health Surveillance Agency
- Canada: Health Canada
- Japan: The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency
- United States: U.S. Food and Drug Administration’s Center for Devices and Radiological Health.
What are the potential benefits of MDSAP?
The MDSAP can offer multiple benefits to medical device manufacturers including:
- Minimises disruptions previously caused by multiple regulatory audits
- Optimises time and resources compared to multiple audits
- Reduces the cost of audits compared to multiple audits
- Covers jurisdiction requirements of the countries engaged in the programme
- Improves the predictability of audit outcomes through enhanced processes.
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