Introduction

The CBPF is issued by ANVISA (National Health Surveillance Agency) for all manufacturers of medical products classified as risk class III and/or IV, whether located in Brazil or other countries. The manufacturer can choose to be audited by ANVISA or by an MDSAP Auditing Organization. Click here to check the authorized scopes for MDSAP. Click here to learn more..

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MDSAP Issued Certificates

Advantages of Using an MDSAP Auditing Organization:

• It is faster to schedule, conduct, and issue an MDSAP audit report.
• This audit can be used for all the following countries:

Members:

• Australia: Therapeutic Goods Administration
• Brazil: ANVISA – National Health Surveillance Agency
• Canada: Health Canada
• Japan: Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
• United States: U.S. Food and Drug Administration

Affiliates:

• 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 whether the manufacturer has undergone an MDSAP audit, and the audit report issued by the Auditing Organization will be used for the issuance of the CBPF.

More information about MDSAP

https://bit.ly/3jUQ4pq

How the process works