Definition Medical Device in MDSAP
MDSAP is an integrated approach to audit and monitoring the industry with an international scale of medical device manufacturer's quality management system.
A regulation developed by IMDRF to conduct a single audit of medical device manufacturers in ISO 13485:2016 and medical device manufacturers that deal with each regulatory requirement.
- MDSAP Enforcement Country
-
- USA(FDA)
- Canada(Health Canada)
- Australia(TGA)
- Japan(MHLW & PMDA)
- Brazil(ANVISA)
- Benefits of MDSAP
-
- Save time and money by conducting a single audit program of Medical devices that meet the requirements of the standard of five countries
- Confidence improvement of the market and enables planned approval.
- Differentiate from other companies with world-recognized certifications