New Hong Kong Medical Device Regulations to be Proposed in 2016

Currently, medical devices do not require registration in Hong Kong. Some foreign device companies have registered their devices via a voluntary system to date.

Recently, Dr. Ko Wing-man, Hong Kong’s Secretary of Food and Health, said that the government will soon finish its report on the regulation of high-risk medical devices. Although the final report has yet to be released, lawmakers are expected to hear new proposed regulations and approve legislation sometime in 2016.

The Hong Kong government seeks to follow established international precedents and create a risk-based regulatory framework. Proposed regulations will be divided into three principle areas including pre-market regulation, post-market regulation, and specific use control. The Department of Health will be the government body charged with designing and implementing the regulatory system.

Under the proposed laws, the government will continue requiring registration for medical devices and in vitro diagnostics classified as Class II or above. A new pre-market safety system will be implemented to assure that medical devices meet safety and quality standards. Conformity Assessment Bodies (CABs) will be formed to carry out audits while a post-market surveillance system will be established in order to report adverse events and continuously monitor safety and performance.