MEDICAL DEVICE SINGLE AUDIT PROGRAM, MDSAP
MEDICAL DEVICE SINGLE AUDIT PROGRAM, MDSAP (USA, Japan, Canada, Australia and Brazil)
Introduction
The Medical device single audit program (MDSAP) is a conceptual program initiated by IMDRF (International Medical Device Regulators Forum). Its purpose is to allow an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities as members of this program. This approach provides more efficient regulatory verification process under a global scale of medical device market, and to shorten time to the market of medical devices.
Manufacturers joined the MDSAP program will need to be audited by a designated auditing organization within single and integrated audit. Once verified, the certification could be recognized by regulatory authorities of the 5 member countries which include FDA, MHLW/PMDA, Health Canada, TGA, and ANVISA. Health Canada had replaced the CMDCAS certification with MDSAP, potentially there will be other regulatory authorities adopting MDSAP instead of current audit and certification. MDSAP had been put into practice at 2017 and SGS is a recognized auditing organization.
Benefits
- Elimination of redundant entrance barriers when approaching different markets
- Reducing loading of preparation to external audits efficiently
- Assisting to expand marketing and sales
- More stringent verification of medical device QMS to be recognized by international benchmark industries
- To shorten time to the market of innovational medical devices
- Improved acceptability of certification by various countries and authorities
- Simplifying inhouse regulatory verification and management
Applicable to
Manufacturers who intend the marketing and sales of medical device to USA, Japan, Canada, Australia, and Brazil
Training Courses
Advance Class of MDSAP and QMS Implementation on 5 Countries Requirements
