ANVISA Grants GMP Certification for Class I–IV Devices to BMC Medical Manufacturing

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ANVISA Grants GMP Certification for Class I–IV Devices to BMC Medical Manufacturing

ANVISA Grants GMP Certification for Class I–IV Devices to BMC Medical Manufacturing

At BMC Medical Manufacturing, we understand that commitment to quality is proven through action. Today, we proudly share another milestone in our history: we have obtained ANVISA’s Good Manufacturing Practices (GMP) certification for medical devices of Classes I, II, III, and IV, covering the full spectrum of medical device risk categories.

This achievement adds to our BPF COFEPRIS and ISO 13485 certifications, as well as our FDA registration as a Contract Manufacturer and Contract Sterilizer — consolidating a comprehensive international compliance framework that validates the robustness of our quality management system and positions us as a national leader in the design, development, manufacturing, and sterilization of medical devices.

ANVISA Certification: Another Milestone in BMC’s Journey

In Brazil, the Agência Nacional de Vigilância Sanitária (ANVISA) classifies medical devices into four risk categories:

Class I: Low risk
Class II: Moderate risk
Class III: High risk
Class IV: Critical risk

By certifying Boas Práticas de Fabricação (BPF) across all categories, ANVISA confirms that our system not only adheres to rigorous processes, but also ensures consistency, safety, and traceability at every stage — from design to post-market activities.

Confidence for Mexico and Beyond

For the healthcare ecosystem in Mexico — including hospitals, clinics, public and private sectors, and biomedical engineering professionals — this certification represents greater trust when choosing a supplier, enhanced traceability, and assurance of a reliable product lifecycle.

In Mexico, biomedical engineering often focuses on clinical practice, commercialization, or academia. BMC Medical Manufacturing breaks that paradigm: we are pioneers in taking biomedical engineering one step further — into the challenges of designing, developing, manufacturing, and sterilizing medical devices, all integrated under a single quality system.

Beyond opening doors to new markets across Latin America, we send a clear message: Mexico has the capability to manufacture under the highest international standards, and BMC Medical Manufacturing stands as a national benchmark in the biomedical sector.

Our Commitment in Action

This achievement reflects a sustained journey over time. The process began in 2024 and concluded 11 months later in 2025 with ANVISA’s resolution — the result of the dedicated work of our team, infrastructure, and quality culture.
At BMC Medical Manufacturing, we will continue to move forward with the same conviction:to design, develop, and manufacture devices under global standards, to boost Mexico’s competitiveness as a regional biomedical hub, and to deliver quality that translates into trust within the medical industry.

Download the Certificate and learn more

Alongside our ISO 13485 and COFEPRIS certificates, we now make available our ANVISA GMP Certificate (PDF), where you can review the official scope of this achievement.