January 15, 2019

Regarding MDCO's plan to expand the listing of the scope of In Vitro Diagnostic Medical Devices (IVDMD) to cover Class B and C, MDCO has conducted a briefing session. As for the briefing Session MDCO explained about Medical Device Administrative Control System (MDACS), Local Responsible Person（LRP), Classification of IVDMD, and How to prepare application documents. In addition, MDCO has also updated the contents of the Guidance Note 06 for In Vitro Diagnostic Listing (IVD) Medical Devices and Technical Reference 006 Medical Device Classification.

The revised summary is as follows:

Other than, Medical Device Control Office will arranges interactive workshop from time to time to help traders in submitting applications to list Class B/C/D IVDMD under the Medical Device Administrative Control System.

Reference:

Medical Device Administrative Control System: Briefing session on Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Device

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