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
1. Overview In Hong Kong, the oversight of medical devices falls under the jurisdiction of the Medical Device Control Office (MDCO). It is tasked with regulating and ensuring compliance with standards for medical devices within the territory. Similarly, the Department of Health... Read More
Last month, PBM’s newsletter outlined how Hong Kong is becoming more advanced in clinical research. On October 31, Hong Kong’s Pharmacy and Poisons Board was allocated “observer status” with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
Today, about 50% of all new drug clinical trials have at least one site in Asia. Despite its small population (about 7.5 million people), Hong Kong is looking to get a piece of the action. Hong Kong has excellent hospitals, doctors, and... Read More
Medical device registration in Hong Kong has been voluntary. Over the last 10 years or so, medical devices could be registered on Hong Kong’s voluntary registration list. However, only about 20% of the medical devices sold in Hong Kong are on the... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More