The Single Audit Program for Health Products (MDSAP) was recognized by the International Forum of Health Products Regulators of which Anvisa is a founding member, for its importance in developing a global approach to auditing and monitoring the manufacture of health products to ensure that they are safe.
The Medical Device Single Audit Program – MDSAP is intended to allow manufacturers of health care products to contract an Audit Body, authorized under the program, to conduct a single audit that will address the relevant requirements of the participating Regulatory Authorities.
The Coordination for Single Audit of Health Products is Anvisa’s representative in the Medical Device Single Audit Program (MDSAP).
Anvisa's international partners for MDSAP
- Health Canada, Canada
- Ministry of Health, Labour and Welfare (MHLW) e a Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Therapeutic Goods Administration (TGA), Australia
- Food and Drug Administration, USA
BGMP and MDSAP
BGMP Application x Manufacturers adhered to MDSAP:
- The procedures to request BGMP from Anvisa have not changed due to the MDSAP.
- The subject of the certification petition remains the same.
Analysis of certification requests:
- Anvisa verifies whether the manufacturer to be certified has joined the MDSAP Program.
- The MDSAP audit report will be used as a subsidy for analyzing the certification process, in which case the inspection to be conducted by Anvisa may be waived.
Learn more about
GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.