Introduction to Regulatory Information of ANVISA in Brazil

① Document Review: The document review phase takes approximately 4 months, and the on-site audit phase is expected to take about 6 months;

② Certification Assessment: The certification assessment phase, which is entered after the audit is passed, is expected to take 2 months.

Q: What are the special requirements for BGMP?

A: The special requirements are as follows:

Procurement: Confirm that the manufacturer's medical device design, procurement, manufacturing, packaging, labeling, storage, installation, or service consultants have the corresponding qualifications or credentials. According to the manufacturer's procurement control [RDC ANVISA 16/2013: 2.3.3], these consultants should be contracted with suppliers. Brazil's ANVISA requires that consulting services also be executed in accordance with the procurement control procedure, which should include evaluation criteria and procedures for suppliers.

Document Control: Confirm change records (including change descriptions), document identification, approval signatures, approval dates, and the effective date of changes [RDC ANVISA 16/2013: 3.1.5]. Confirm that the manufacturer holds a master list of approved and effective documents [RDC ANVISA 16/2013: 3.1.5]. Confirm electronic records and document backups [RDC ANVISA 16/2013: 3.1.6].

Nonconforming Products: Confirm the evaluation of nonconforming products, including the investigation and notification of persons or organizations responsible for nonconforming products. Assessments and any other investigations must be documented [RDC ANVISA 16/2013: 6.5.1]. Verify that the manufacturer has product recall procedures and other field actions related to distributed products [RDC ANVISA 16/2013: 7.1.1.8].

CAPA: Confirm the identification of quality issue documents and submit corrective and preventive actions to the administrative department for notification and monitoring (if applicable) [RDC ANVISA 16/2013: 7.1.1.7].

Q: If an extension is needed, when should the application be submitted?

A: BRH should submit the application 180-270 days before the BGMP certificate expires.