Registration is the regulatory process of obtaining official authorization from a health authority to legally market and sell a medical device in a specific country or region.
Complete Guide to Registration
Medical device registration is the formal regulatory process required before a manufacturer can legally market, sell, or distribute a medical device in a specific jurisdiction. Each country or region has its own regulatory framework, timelines, and requirements.
What Registration involves:
- Submission of technical documentation to regulatory authorities
- Demonstration of safety and effectiveness
- Compliance with local regulations and standards
- Payment of applicable fees
- Appointment of local representatives or importers
- Ongoing compliance and renewal obligations
Major Global Registration Pathways:
United States (FDA):
- 510(k) Premarket Notification - Moderate-risk Class II devices (3-6 months)
- PMA (Premarket Approval) - High-risk Class III devices (12-18 months)
- De Novo - Novel low-to-moderate risk devices (6-12 months)
- Establishment Registration and Device Listing required
European Union (EU MDR):
- Class I - Self-certification with Declaration of Conformity
- Class IIa/IIb/III - Notified Body certification required (12-24 months)
- CE Marking affixed upon conformity assessment completion
- EC REP (European Authorized Representative) mandatory for non-EU manufacturers
China (NMPA):
- Class II/III - Clinical trial and registration approval (18-36 months)
- Very detailed technical documentation in Chinese
- Chinese Agent required
Other Major Markets:
- Brazil (ANVISA) - 6-18 months, requires Brazilian Registration Holder (BRH)
- Canada (Health Canada) - Medical Device License (3-12 months)
- Japan (PMDA) - Approval or Certification (12-24 months)
- Australia (TGA) - Registration or Listing (1-12 months)
Common Registration Requirements:
- Quality Management System certification (ISO 13485)
- Technical file or Design Dossier
- Clinical evidence or evaluation
- Risk management documentation (ISO 14971)
- Labeling in local language
- Certificate of Free Sale from country of origin
Registration Validity: Most registrations are valid for 3-5 years and require renewal with updated documentation and fees.
Related Terms
More General Terms
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A broad category of technologies that use computing platforms, connectivity, software, and sensors to support healthcare and health-related applications.
The process of aligning medical device regulatory requirements, standards, and procedures across different countries and regions to facilitate international trade and improve patient safety.
Need Help with Global Registration?
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