Anvisa Doubles Validity of Good Manufacturing Practice Certificates

Brazil’s National Health Regulatory Agency (Anvisa) has announced an extension of the validity period for Good Manufacturing Practice (GMP) certificates. Medical device manufacturers participating in the Medical Device Single Audit Program (MDSAP) will now see the validity of their certificates extended from two to four years.

This change, which comes into effect with the publication of RDC 850 on March 20, 2024, was unanimously approved during the Collegiate Board meeting (ROP 03/2024) held on March 19. The directors of Anvisa have highlighted that this amendment will create a more favorable environment for compliance with the MDSAP, reducing the regulatory costs for companies, while at the same time improving monitoring and bringing efficiency and agility to the agency’s operations.

The extension of the validity of the certificate is contingent upon the manufacturer’s continued participation in the MDSAP throughout the life of the certificate. This ensures ongoing annual audits to monitor risk and verify compliance with good manufacturing practices, helping to control the health risks associated with the products.

Understanding the MDSAP

The MDSAP is designed to allow medical device manufacturers to engage a single auditing organization to conduct an audit that covers the relevant requirements of the regulatory authorities that are official participants in the program. These include Anvisa (Brazil), Health Canada (Canada), TGA (Australia), FDA (United States), and PMDA (Japan).

The growth of the program in recent years has led to an increase in international partners. Official observers include the World Health Organization (WHO), the European Community (EU) and the MHRA (United Kingdom), with affiliate members from Argentina, Israel, South Korea, Singapore, Taiwan, Mexico and Kenya.

Anvisa has benefited from the MDSAP because the good manufacturing practice certification issued by the agency is done through the analysis of reports and certificates issued by the auditing bodies, eliminating the need for its own inspections. This measure has been instrumental in speeding up the issuance of GMP certificates and saving human and financial resources.

Impact on the industry

The decision to extend the validity of GMP certificates demonstrates Anvisa’s commitment to supporting the growth of the medical device industry while ensuring public health safety. It reflects a balance between regulatory oversight and industry facilitation, which is critical to fostering innovation and competitiveness in the global marketplace.

As the medical device industry continues to evolve, such regulatory adaptations are essential to maintaining Brazil’s position as a key player in the healthcare sector. Anvisa’s move is a clear indication of its forward-thinking approach and commitment to improving the country’s healthcare standards.