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.