Hong Kong medical device listing application
Hong Kong, China · Usually approximately 8–16 weeks after all information and product technical documents are complete; medical device classification, conformity assessment and supplementary submissions may extend this.
- Estimated timeline
- 8-16 weekscounted from receipt of complete documents
- Key deliverable
- Medical device listing application receipt
- Packages
- Standard service
What you provide
- Certificate of Incorporation and Business Registration Certificate
- Applicant/local responsible person information
- Medical device name, model, classification and intended use
- Manufacturer, authorized representative and supply chain information
- Quality management system and conformity assessment certificates
- Safety, performance, labeling and instructions for use information
- Overseas registration/approval and adverse event documentation
- Application forms and supplementary documents required by the Medical Device Division.
What you receive
- Medical device listing application receipt
- Medical Device Division supplementary submission and technical review records
- Medical device listing result/number (upon approval)
- Product category, manufacturer and local responsible person information
- Post-market surveillance and change notifications.
Service details
This service covers Hong Kong medical device listing applications. Actual applicable conditions, processing criteria and competent authority requirements will be confirmed by an advisor based on the application before acceptance.
Est. processing time
Usually about 8–16 weeks once all documents and product technical files are complete; medical device classification, conformity assessment and supplementary submissions may extend this.
Prices follow the service listing. Where government approval or official review is involved, the outcome rests with the authorities and cannot be guaranteed.