Quackbuster: Singapore 6

Still tracking the Health Products Act...


Regulation of all medical devices by 2010

REPORTING to the authorities problems relating to medical devices sold. Keeping complaints and distribution records of such devices.

These are among the legal obligations that dealers of medical devices will have to adhere to from Nov 1 as the Health Sciences Authority (HSA) begins implementing the regulation of such products.

Medical devices, which range from syringes to artificial hearts, are the first category of health products to be regulated under the Health Products Act, which was passed by Parliament in February.

The control measures will be implemented in phases, from next month, to "minimise the impact of the supply of medical devices and to provide sufficient time for the industry to meet the new standards and requirements", said the HSA yesterday.

At the same time, action will also be taken against dealers who engage in "fraudulent advertisements".

The next phase, from next April 1 to Oct 1, 2009, will involve the licensing of dealers, including manufacturers, importers and wholesalers, as well as registration of medical devices.

The final year-long phase, which will end on Oct 1, 2010, will require all parties dealing with medical devices to be licensed and for all such products to be registered.

By the time all the regulatory measures are in place, it will be illegal to manufacture, import or supply "unregistered medium and high-risk devices" — from Oct 1, 2009 — and "low-risk products" — from Oct 1, 2010 — the HSA said.

With these new regulations, consumers can expect better protection from unsafe or poor quality products and more objective information to help them make better decisions.


angry doc dares not imagine that the Health Product Act is enacted primarily to combat quackery, but he hopes that it will have an impact.

In an ideal world we won't need such a law - people (consumers) will all be wise and discerning and will scorn any health product with "fraudulent advertisement", insisting instead on good quality evidence. Of course, that day may never come. In the meantime, angry doc is glad that we have such a law.

Still, he cannot but feel that he is applying double standards to how we legislate on health-seeking behaviour in looking at the case of the Health Products Act and that of the proposed amendments to the Infectious Diseases Act.