HONG KONG: Proposal of Regulation for beauty/aesthetic medical device and Voluntary plan for Class B
The proposal of regulation on medical devices used in the beauty trade has been submitted by the Department of Health (DoH) to Hong Kong’s Legislative Council in January 2017.
The beauty trade has provided their inputs and voiced much objection to the proposed regulation. Further follow-up by DoH with Legislative Council is still foreseen in the next half of the year.
In the proposal, all medical device used in beauty/aesthetic will be categorised into 4 levels. Except for the lowest risk medical device used in beauty/aesthetic, all higher risk level medical device used in beauty/aesthetic is proposed to be in the regulated environment. A certain transition period for the control of this device may likely be introduced.
Currently, other medical devices (except class 1 lowest risk) and Class D highest risk IVD devices including non-beauty/aesthetic medical device can be submitted under Voluntary registration to the Medical Device Control Office, DoH. For IVD device industry, all Class B and C IVD device may be introduced this year under the voluntary registration under MDCO, DoH Hong Kong.
Medical devices are classified into 4 risk-based classification, namely Class 1 (low risk), 2, 3, 4 (higher risk). IVD devices are classified into 4 risk-based classification, namely Class A (low risk), B, C, D (higher risk). The proposal to control all these devices may be submitted later in the year after the implementation for the control of beauty/aesthetic medical device.