Recently, there is a new regulation that allows the Thai FDA to hasten the review of device registration dossiers. It has agreed to let device companies reference registration dossiers for new registrations of the same product with different brand names. In short, the Thai FDA is... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
As mentioned recently in our newsletter, Hong Kong’s Health Authority is being bulked up to take more responsibility in approving healthcare products. This past summer, the Department of Health set up the Hong Kong Centre for Medical Products Regulation. Whereas in the... Read More
The Department of Health (DH) is set to enhance its medical device procurement strategy, building on the first phase implemented on June 21, 2023. The second phase of this strategy will be introduced in two stages to ensure better quality and safety... Read More
On June 5, Hong Kong’s Department of Health (DH) announced the establishment of the Preparatory Office for the Hong Kong Centre for Medical Products Regulation (CMPR). This initiative seeks to enhance the regulatory and approval processes for pharmaceuticals and medical devices in... Read More
The Hong Kong government has been updating its regulatory framework for medical devices, with a number of key changes that seek to enhance safety, efficacy, and compliance. Compulsory Procurement Registration On June 21, 2023, the Hong Kong Department of Health (DOH) launched... Read More
Hong Kong, with a population of 7.5 million people, is a good market for medical devices. While voluntary device registration is only required now, mandatory registration is on the horizon. Voluntary device registration is important since Hong Kong hospitals and clinics strongly... Read More
Late last year, Hong Kong’s Medical Device Department made public Technical Reference TR – 007. The guidance defines and classifies Software in a Medical Device (SIMD) and Software as a Medical Device (SAMD). SIMD is used for medical purposes and controls or... Read More
On December 22, 2023, Hong Kong’s government issued a new update (GN-10) to its Medical Device Administrative Control System (MDACS). It is the Hong Kong local agent‘s job (local responsible person or LRP) to report product registration changes and update the MDACS.... Read More
In the past, drug registration in Hong Kong required that a foreign drug had approval in 2 reference countries. Late last year, the Hong Kong Department of Health announced the “1+” mechanism which now allows drug approval if the drug has been... Read More