The medical device industry is rife with complex regulations that vary by geographical region. Understanding the differences between the leading regulatory agencies is essential for success in the global medical device market. Here’s a comparative analysis of FDA, ANVISA, and MDR classifications and regulations.
| ASPECT | FDA (USA) | ANVISA (Brazil) | MDR (EU) | |
| Classifications | Class I, II, III, IV | Class I, II, III, IV | Class I, IIa, IIb, III | |
| Approval Process | Pre-Market (510(k), PMA) | Registration, Authorization | Conformity Assessment | |
| Clinical Evaluation | Required for some classes | Required for some classes | Required for some classes | |
| Labeling Requeriments | Strict | Strict | Strict | |
| Registration Validity | Not Required | Class I and II – Indeterminate Class III and IV – 10 years | Periódica (5 anos) | |
| Local Technical Responsible | Not Required | Required | Required | |
| Post-Market Requeriments | Surveillance e Recalls | Surveillance e Recalls | Surveillance e Recalls | |
| Regulatory Authorithy | FDA | ANVISA | European Comission | |
| Jurisdiction | United States | Brazil | European Union | |
Legend:
Class I: Low-risk medical devices. Class II: Moderate-risk medical devices.
Class III: High-risk medical devices. Class IV: Maximum-risk medical devices.
Observations:
- FDA and ANVISA adopt a risk-based approach to classification, while MDR has additional subdivisions.
- FDA’s approval process involves 510(k) for Class II devices and PMA for Class III and IV.
- MDR requires conformity assessment, and ANVISA demands authorization.
- MDR requires comprehensive risk assessment and is regulated by the European Commission.
- Each agency has jurisdiction over medical devices in their respective regions.
It’s crucial to understand these differences when bringing medical devices to specific markets. Regulatory compliance is essential for ensuring patient safety and product success.
ANVISA ultimately determines the classification of a medical device for marketing in Brazil. Materials, equipment, orthopedics, and IVDs have their respective standards, RDC 751/2022 and RDC 36/2015, which determine how products should be classified and how models should be grouped into families, kits, or systems. At BRISA ADVISORS, we offer a free classification service and determination of the regulatory pathway upon receiving product usage instructions at contactBR@brisa.com.br.
#MedicalDevices #Regulations #Health #FDA #ANVISA #MDR
Disclaimer: This post is for informational purposes and does not replace consultation with the official regulations of the corresponding regulatory agencies. Always consult official sources for precise and up-to-date guidance.
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* Budget for the registration ownership transfer, Market Access Strategy and BPO in RA services for your company: www.brisa.com.br
