Overview:
The National Health Surveillance Agency (Anvisa) has decided to increase the validity period of the Certificate of Good Manufacturing Practices (CBPF) for medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP) from two to four years. This extension was made official by Collegiate Board Resolution (RDC) number 850, of March 20, 2024.
Introduction:
This change reduces regulatory costs for companies and, at the same time, increases monitoring, providing efficiency and agility to Anvisa’s operational procedures. It is important that companies engaged in the program undergo annual audits. The aim of these audits is to monitor risks and verify continued adherence to good manufacturing practices, which is essential for controlling the health risks associated with products. The new policy, which extends the validity of the certificate to four years, is conditional on the manufacturer’s continued participation in the MDSAP (Medical Device Single Audit Program) throughout the certificate’s validity period.
Introduction to MDSAP
The MDSAP aims to facilitate the process for medical device manufacturers by allowing them to contract a single auditing entity, responsible for carrying out audits that meet the regulatory requirements of the program’s member countries. These countries currently include Australia, Brazil, Canada, Japan and the United States.
This system allows audit results, including reports and certificates, to be used by companies to meet regulatory requirements in participating countries. The expansion of MDSAP over the last few years demonstrates an increase in the number of international partners joining the program, reinforcing its importance and effectiveness in standardizing good manufacturing practices for medical devices globally.
Official members:
Anvisa (Brazil).
Health Canada (Canada).
TGA (Australia).
FDA (United States); and
PMDA (Japan).
Official observers:
World Health Organization (WHO).
European Community (EU); and
MHRA (United Kingdom).
Affiliate members:
ANMAT (Argentina).
MTIIR (Israel).
MFDS (South Korea).
HSA (Singapore).
TFDA (Taiwan).
COFEPRIS (Mexico); and
Kenya’s Pharmacy and Poisons Board (Kenya).
Anvisa's integration with MDSAP
Anvisa has found great value in integrating with the MDSAP program, mainly because the certification of good practices provided by the Agency is based on the evaluation of reports and certificates issued by independent auditing entities. This approach eliminates the need for Anvisa to conduct its own on-site inspections. This strategy has been extremely beneficial, allowing Certificates of Good Manufacturing Practice (CBPF) to be issued in a more efficient and cost-effective manner, significantly saving time, human effort and financial resources.
How to Become an MDSAP Participant
For medical device manufacturers who are interested in joining the MDSAP, it is essential to start the process by contacting one of the auditing entities officially recognized and accredited by the program. The unified audit scheme adopted by the MDSAP makes it easier for audit results – specifically the certificates and reports generated – to be recognized and accepted by regulatory authorities in different countries. This not only promotes international regulatory harmonization, but also reduces costs and speeds up the approval process for the marketing of medical devices in the markets involved.
When Anvisa receives applications for certification, it carefully checks whether the manufacturer in question has undergone an audit according to MDSAP standards. In such cases, the Agency relies on MDSAP reports and certificates provided by accredited auditing bodies to support its analysis of the certification application, including documents that have already been submitted.
Additional, detailed information on MDSAP can be found on the program’s official website and on the Anvisa portal.
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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.