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.