The Health Sciences Authority (HSA) of Singapore has recently issued various Guidance Document drafts on their website. As described in Volume 7, Issue No. 10, Singapore passed its Health Products Act in February 2007 to regulate all medical products, including medical devices.
The first phase primarily deals with implementing certain duties and obligations on medical device dealers, as well as regulating advertisements and promotions. In HSA’s proposed documents, advertisements should not carry testimonials or recommendations by health professionals. Advertisements should also be accurate, truthful, and supported by scientific data when necessary.
Registrants, manufacturers, importers, and wholesalers (including exporters) would all be required to maintain distribution records of each device product. As of now, HSA has proposed basic information requirements, such as batch numbers, date shipped, and quantity of devices shipped. HSA has also proposed definitions for reportable adverse events and timelines. All persons who register, manufacture, import, and supply device products in Singapore would be required to report adverse events involving medical devices placed on the market.
HSA also drafted Guidance Notes on preparing a Site Master File. The proposed requirements include general information on the site, personnel, layout and description of the facilities, inventory control, documentation, handling recalls, etc.
HSA issued these draft documents at the end of October 2007 and asked for comments by November 2007. As of now, there have been no revised, formal updates posted by the HSA on their website.