Drugdu.com expert's response:

Medical devices that have obtained FDA and CE certifications can expedite registration and market access in Brazil, primarily reflected in simplified review processes, reduced redundant testing, and shortened approval cycles. The specific acceleration mechanisms and operational points are as follows:

I. Acceleration Mechanisms: ANVISA's Recognition of International Certifications

The Brazilian National Health Surveillance Agency (ANVISA) explicitly allows referencing international authoritative certification results (e.g., FDA, CE) to streamline registration processes. According to ANVISA’s IN 290/2024 directive:

1. Technical Document Mutual Recognition

If a product has obtained FDA or CE certification, ANVISA may directly adopt its technical evaluation results (e.g., design validation, performance testing, biocompatibility), minimizing redundant reviews.

For example, clinical data and risk assessment reports (ISO 14971) from CE certification can be directly used to support Brazilian registration, avoiding resubmission.

2. On-Site Audit Exemption

For Class III and IV high-risk devices, if a company holds an MDSAP (Medical Device Single Audit Program) certificate, ANVISA may waive on-site audits and complete evaluations solely through document review.

MDSAP covers five countries—the U.S., Canada, Brazil, Australia, and Japan—enabling compliance with multiple markets through a single audit, significantly shortening registration cycles.

3. BGMP Issuance Acceleration

If manufacturing facilities have passed FDA’s QSR 820 or CE’s ISO 13485 certifications, ANVISA may streamline its GMP (Good Manufacturing Practice) review process, expediting BGMP (Brazilian GMP) certificate issuance.

II. Acceleration Outcomes: Time and Cost Optimization

1. Time Reduction

Conventional registration cycles range from 6 months to 2 years, while leveraging international certifications can shorten them to 3–6 months (low-risk devices) or 6–12 months (high-risk devices).

Example: A Class III cardiovascular device with MDSAP certification saw its ANVISA registration cycle reduced from 18 months to 9 months.

2. Cost Savings

Reduces redundant testing expenses (e.g., biocompatibility, performance testing), saving approximately 20%–30% of registration costs.

Eliminates travel and labor costs associated with on-site audits, further lowering compliance expenses.

III. Operational Points: Maximizing International Certification Benefits

1. Document Completeness

When submitting FDA/CE certification documents, ensure they include core content such as technical specifications, clinical data, and risk management reports, translated into Portuguese.

Supplement with Brazil-specific requirements (e.g., labeling, instruction format) to avoid delays due to missing information.

2. Prioritize MDSAP Certification

If targeting markets including Brazil, the U.S., and Canada, prioritize MDSAP audits to achieve "one audit, multi-country access."

MDSAP certificates can replace partial ANVISA on-site audits, accelerating high-risk device registration.

3. Partner with Local Agents

Engage Brazilian local agents (e.g., Jitong Medical Group) to handle registration affairs. Their familiarity with ANVISA processes ensures efficient document submission and feedback coordination.

Local agents also provide value-added services like label reviews and regulatory updates, reducing compliance risks.

4. Stay Updated on Policies

ANVISA may adjust policies (e.g., IN 290/2024 directive) based on international certification standards. Regularly monitor its official website or consult professionals to align strategies with the latest requirements.

IV. Case Studies: Real-World Acceleration Effects

Case 1: Class II Diagnostic Device

Already CE-certified, the device submitted CE technical documents and clinical data, leading ANVISA to waive partial testing. The registration cycle shortened from 8 months to 4 months.

Case 2: Class IV Implantable Device

With an MDSAP certificate, ANVISA waived on-site audits and issued registration certificates solely through document review, reducing the cycle from 24 months to 12 months.