Lifecycle of a Medical Device in Hong Kong

1. Classify the Device

Use TR-003 (general) or TR-004 (IVD) to determine risk class. Class I / Class A devices are not eligible for MDACS listing.

2. Appoint an LRP (Foreign Manufacturers)

Foreign manufacturers appoint a Hong Kong-based LRP who will manage the listing and hold post-market responsibilities.

3. Compile Technical Dossier

Prepare conformity evidence: ISO 13485, essential principles compliance, risk management, clinical evaluation, labelling.

4. Submit via MDIS

The LRP submits the application through the Medical Device Information System (MDIS). Choose either the standard route or the expedited reliance scheme.

5. Receive HKMD Number

Upon MDD approval, the device receives an HKMD listing number and appears in the public MDIS database.

6. Ongoing Post-Market

The LRP monitors safety, reports adverse events, manages FSCAs, handles complaints, and tracks devices. Notify MDD of significant changes.

Standard review typically takes 4–8 weeks from submission via MDIS, depending on dossier completeness and device complexity. The actual timeline may extend if the MDD issues information requests or if the dossier is incomplete. The expedited reliance scheme may reduce review time if reference-country approvals (e.g., FDA, CE mark, TGA) are available. The MDD may request additional information or clarification, which pauses the review clock.

The current text mentions 'The MDD may request additional information or clarification, which pauses the review clock.' This should be expanded to: 'The MDD may request additional information or clarification during review, which pauses the review timeline. Manufacturers must submit responses within a specified timeframe (typically 30 days); failure to respond may result in application withdrawal. The review clock resumes upon receipt of complete responses.'