Changes in the Singapore Medical Device Regulatory System

The regulatory system for medical device registration in Singapore is changing. On April 1, 2001, changes in regulations as well as a new statutory board were announced. The new agency, called the Health Sciences Authority (HSA), aims to provide a “one-stop, multi-disciplinary body to regulate healthcare products.” The HSA will integrate the following departments of the Ministry of Health: The Centre for Drug Evaluation, the Institute of Science and Forensic Medicine, the National Pharmaceutical Administration, the Centre for Medical Device Regulation (CMDR) and the Singapore Blood Transfusion Service.

Singapore’s Health Ministry expects a mandatory product registration system to be in place in about two years time. As a first step, however, a period of transition was announced whereby local authorized medical device representatives are encouraged to voluntarily register their medical products with the CMDR. The Voluntary Product Registration Scheme will provide a period of confidence building and also time to evaluate the feasibility of the proposed medical device regulation framework. Currently, the Voluntary Product Registration Scheme targets only medical devices that are categorized as medium to high risk (Class IIa, Ilb, and III). By the third quarter of this year, the proposed Medical Device Regulations will be more fully implemented.

The CMDR is also reviewing medical device regulations in the US, Europe, Australia, and Japan in order to formulate their own regulatory standards. Currently, medical devices that are approved for use in these countries are generally accepted into the Singaporean market when appropriate certificates are available. The Centre plans to adopt “consensus standards and requirements on safety, quality and performance which satisfy the regulatory requirements of developed countries.”