Singapore's Minister of Health, Mr Khaw Boon Wan, has highlighted the need for new legislation to regulate medical devices and other new categories of health products. In his Parliamentary speech on the draft Health Products Bill given on 12 February 2007, he said that while existing laws cover pharmaceutical medicines, other health products such as cardiac pacemakers and coronary stents are largely unregulated.
With recent advances, there is a wide range of existing and new medical and health products that may need to be reviewed and monitored. To this end, the proposed framework is based on the international Global Harmonisation Task Force's (GHTF) principles, which recommend that the level of regulation be proportional to the degree of risk involved.
The salient features of the new Bill are :
- Whilst the Bill's scope is defined widely, not all health products will come under the Health Products Act immediate regulation. It will start with medical devices, with other categories of products being added over time, as required. Product categories that have not been added will remain under the regulation of existing laws.
- The administration and enforcement of the Act will rest mainly with the Health Sciences Authority (HSA).
- On product advertisements and claims, the HSA is empowered to direct an advertiser to publish a corrective notice if an advertisement is found to be misleading.
- A Register of Health Products will list all categories of products that have to be registered and enable the consumer public to check the registration status of a particular product.
- The Act also allows the Agri-Food and Veterinary Authority (AVA) to make subsidiary legislation to regulate health products used for veterinary purposes.