OVERSEAS CERTIFICATION

MDSAP

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