The Medical Device Control Office of Hong Kong (MDCO) has proposed listing local manufacturers of medical devices under the Medical Device Administrative Control System (MDACS). The main requirement to be listed will be for manufacturers to implement and maintain a quality management... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a “Common Submission Dossier Template” (CSDT). If adopted, this would allow medical device companies to use one common form when submitting to any of the 13 countries in the AHWP. By adopting this... Read More
The Medical Device Control Office (MDCO), part of Hong Kong’s Department of Health, recently made official the Conformity Assessment Framework. This is a framework for new conformity assessment requirements for medical devices and information on Conformity Assessment Bodies (CABs). Hong Kong currently... Read More
While orphan drug laws in Asia may provide benefits for companies registering new drugs, such as marketing exclusivity, an expedited registration process, and a reduction in the number of clinical trials required, each registration process is unique and can pose a variety... Read More
The Hong Kong Medical Device Control Office (MDCO) is planning to introduce a conformity assessment (CA) framework as part of its its Medical Device Administrative Control System (MDACS). The framework is intended to improve the quality management of medical devices. The CA... Read More
In 2003, Hong Kong’s Department of Health (DOH) launched the Medical Device Administrative Control System (MDACS). The first phase of the MDACS, which began on November 26, 2004, permitted medical device companies to voluntarily list their Class IV (high-risk) medical devices. The... Read More
In July 2005, the Hong Kong Hospital Authority began implementation of its Drug Formulary, a list of over 1,200 standard drugs to be prescribed by doctors in public hospitals and clinics. Most drugs will not be affected by the Formulary, but there... Read More
To expand their sales in the Asian medical markets, medical companies need to stay abreast of the new and changing regulatory environments for drugs, devices and In Vitro Diagnostics (IVDs). New or improved regulations are implemented frequently in Asia, including changes in... Read More
On January 1, 2005, the 2 nd phase of Mainland China and Hong Kong’s Closer Economic Partnership Arrangement (CEPA) was launched. CEPA was established to remove barriers to trade between Hong Kong and the Mainland and to promote investment and cooperation. Under... Read More
First proposed in 2003 and based on recommendations from the Global Harmonization Task Force, Hong Kong’s Department of Health (DOH) launched the Medical Device Administrative Control System (MDACS). MDACS, which is managed by the Medical Device Control Office (MDCO), will be launched... Read More