How to use the MDSAP to obtain the CBPF (Certificate of Good Manufacturing Practices) from ANVISA?
The CBPF is issued by ANVISA (Brazilian Health Regulatory Agency) for all medical products with risk class III and/or IV manufacturers in Brazil or other countries. The manufacturer can be audited by ANVISA or an Auditing Body of the MDSAP. Click here to check the accredited scopes for MDSAP.
Advantages of using an MDSAP Auditor Body:
- • It’s faster to schedule, perform, and report an MDSAP audit.
- • This audit can be used for all of the following countries:
- • Austrália: Therapeutic Goods Administration of Australia
- • Brasil: Brazilian Health Regulatory Agency
- • Canadá: Health Canada
- • Japão: Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- • Estados Unidos: U.S. Food and Drug Administration
- • Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT)
- • Republic of Korea’s Ministry of Food and Drug Safety
In the Certification process, ANVISA will verify if the manufacturer conducted the audit via MDSAP.
The audit report issued by the Auditing Body will be used to issue the CBPF.
How the process
the MDSAP form for NCC Certificações;
the completed form informing the markets for which you want to use the MDSAP program;
will evaluate the information and establish the number of audit days following the MDSAP rules, and the proposal will be sent;
starting the process, NCC will request some Quality Management System documents for step 1. After the documents are accepted, the audit will be scheduled;
will perform the audit, and once everything complies with the MDSAP requirements, the certificate will be issued;
certificate will be used by the company for the markets included in the audit following the form completed by the customer;
year, the factory will undergo maintenance audit;
8. It is possible
to add another market after issuing the certificate by adapting the process.