Medical Device Single Audit Program
Under the Medical Device Single Audit Program (MDSAP), the medical device manufacturers can let a recognized auditing body to conduct a single medical devices audit, for acceptance by the regulatory authorities of the participating countries. With the application of MDSAP, better alignment of regulatory approaches and technical requirements on medical devices can be expected in the future.
- Food and Drug Administration (FDA) of USA
- Health Canada (HC)
- Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
- Therapeutic Goods Administration (TGA) of Australia
- Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil
The Official Observers of the MDSAP include:
- The World Health Organization (WHO)
- Prequalification of In Vitro Diagnostics (IVDs) Program
- Program and the European Union (EU)
After the launch on Jan 1, 2014, and following a 3-year pilot ending on Dec 31, 2016, the MDSAP started its operational phase form Jan 1, 2017.
Transition from CMDCAS to MDSAP
MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program. The period for transitioning from CMDCAS began from Jan 1, 2017. During the following 2-year transition period, the certificate under CMDCAS will be accepted by Health Canada until Jan 1, 2019.
MDSAP by DQS
DQS Med is one of recognized Audit Organizations for MDSAP. Besides the roles of certification body for ISO 13485:2016 certification and Notification Body for medical devices and CE marking, DQS can provide a MSDAP audit covering all applicable requirements of the participating regulatory authorities. The MDSAP will help your organization to reduce internal resource with lower audit cost for access to different markets.
Contact DQS-HK to answer any questions you have on MDSAP for medical devices.
Training by DQS