Measure Simplifies the Process for Good Manufacturing Practices Certification
Regulatory Streamlining in Medical Device Manufacturing Certification
The Brazilian National Health Surveillance Agency (Anvisa) has unified the subject codes used when petitioning for the Good Manufacturing Practices Certificate (CBPF – Certificado de Boas Práticas de Fabricação) for medical devices. This regulatory initiative aims to simplify the regulatory process, reduce bureaucracy, and align procedures with current legislation.
Key Changes in the Regulatory Framework for Medical Devices
With the new measure, all medical devices—including in vitro diagnostic products—will be handled under the same petition subjects, reflecting the approach already adopted by Collegiate Board Resolution (RDC) 751/2022, which establishes a unified structure for GMP requirements.
The unification of petition subjects also encompasses medical products and in vitro diagnostic products, regardless of their industrial origin (national, international, or Mercosur), and within the context of the Medical Device Single Audit Program (MDSAP). The change represents a significant step forward in debureaucratization for the sector, promoting greater efficiency in certification processes and alignment with international practices.
Impact on Pending Processes
Anvisa informs that there will be no impact on CBPF processes already filed or under analysis, even if they were submitted under previous petition subjects.
Furthermore, during the renewal process for CBPFs for manufacturing units that produce both medical products and in vitro diagnostic products, it will be possible to opt to renew only one of the processes, preferably the one with the closest expiration date, provided that the information for all involved medical devices is consolidated in the petition form.
Alignment with International Standards
This unification effort demonstrates Anvisa’s commitment to harmonizing Brazilian regulations with global standards, particularly in relation to:
- Compliance with GMP across all medical device categories.
- Integration with MDSAP for international manufacturers.
- Alignment with the Health Sciences Authority and best practices.
- Standardization of Medical Device Authority requirements.
Benefits for Medical Device Companies
The consolidation of petition subject codes offers several advantages for companies operating in the medical device sector:
- Simplified Submission Process: A single pathway for all device types.
- Reduced Administrative Burden: Fewer codes to navigate.
- Greater Regulatory Clarity: Aligned with the RDC 751/2022 framework.
- Cost Efficiency: Optimized certification procedures.
- International Harmonization: Better alignment with MDSAP requirements.
Accessing the New Petition Subjects
Companies can consult the new petition subjects through the official Anvisa portal at: https://consultas.anvisa.gov.br/#/consultadeassuntos/
For organizations seeking medical device consulting support or guidance on FDA registration and international compliance, understanding these changes is crucial for maintaining regulatory compliance in Brazil and abroad.
Implications for Medical Device Regulatory Strategy
This regulatory update reinforces the importance of maintaining robust quality management systems and staying current with evolving regulatory requirements. Companies that manufacture medical devices, whether for the domestic market or export, should review their certification strategies to take advantage of these simplified procedures.
Organizations involved with laboratory-developed tests, software as a medical device (SaMD), or other innovative medical technologies should pay special attention to how these changes affect their certification timelines and requirements.
Official Source: Anvisa – Unification of Petition Subject Codes for CBPF
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