In mapping its regulatory framework for medical devices, HSA has adopted a measured approach to safeguard public health but without unduly restricting consumer choice and their access to new technologies. HSA has also studied the medical device regulatory systems in developed country counterparts, including the US Food and Drug Administration (FDA), European Union, Canada's Medical Devices Bureau (MDB), Japan's Ministry of Health Labour and Welfare (MHLW) and Australia's Therapeutic Goods Administration (TGA).

The proposed regulatory framework will be based on the principles endorsed by the Global Harmonisation Task Force (GHTF) with modification to suit the Singapore context. This applies the concept of risk management to ensure that the level of regulation is proportional to the degree of risk involved and the benefits offered in using a medical device.

Since the implementation of the Voluntary Product Registration Scheme in 2002, HSA had an active post market monitoring and surveillance program for medical devices in place.

With the passage of the Health Products Act 2007 in February 2007, HSA will be implementing the Health Products (Medical Devices) Regulations to better regulate medical devices in Singapore.

Regulatory control for medical devices in Singapore will be implemented in 3 phases. This will minimise disruption to the supply of medical devices to users and provide time for the companies to comply with the requirements and register their products.

Please visit this page regularly for updates.

From 1 November 2007, the following duties and obligations will be imposed on medical device dealers. Medical device dealers must:

• Report adverse events to HSA within stipulated time frame
• Notify HSA prior to the initiation of a product recall
• Keep records of complaints and product distribution

The false or misleading advertisements and promotions of medical devices will be prohibited. HSA can direct an advertiser to publish a “corrective advertisement” for any false or misleading advertisements.

From 1 November 2008, HSA has started accepting applications for licensing of dealers of medical devices and registration of medical device products.

The last phase of the implementation will be conducted in 2 stages:

From Stage 1 (10 August 2010 onwards):

• Unlicensed manufacturing, importation and wholesaling of medical device is prohibited
• Class C and D medical devices (but excluding those medical devices currently licensed under the Radiation Protection Act by the Centre for Radiation Protection and Nuclear Science (CRPNS) of the National Environment Agency (NEA)) that are imported and supplied must meet one of the criteria below:
  • Listed on the Singapore Medical Device Register (SMDR);
  • Listed on the Transition List; OR
  • Authorised via one of the Authorisation Routes.

NOTE: Class C and D medical devices currently licensed under the Radiation Protection Act by the Centre for Radiation Protection and Nuclear Science (CRPNS) of the National Environment Agency (NEA) shall be exempted from product registration with HSA until 01 August 2011.

From Stage 2 (01 Jan 2012 onwards):

Unless exempted from product registration, all medical devices, including class A and B medical devices, that are imported and supplied must meet one of the criteria below:

• Listed on the Singapore Medical Device Register (SMDR);
• Listed on the Transition List; OR
• Authorised via one of the Authorisation Routes.

For an understanding of the product registration and licensing of dealers process and requirements, you can download the following Quick Guide.