The Public Consultation on the Proposed Health Products (Medical Devices) Regulations is now closed.

The Public Consultation was held over an 8-week period from 6 February to 3 April 2007.

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 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.

HSA's proposed regulatory framework incorporates the following elements from the regulatory model recommended by the GHTF : 

• Definition of medical devices 
• Risk-based classification system and rules 
• Essential principles of medical devices for ensuring the safety and performance 
• Risk-based assessment and risk management

The proposed framework comprises the following key elements:

a) Licensing of establishments dealing with medical devices

These licensing controls are aimed at regulating the supply chain and ensuring that only bona fide persons are engaged in dealing with medical devices. The main control is on the supply chain in the ordinary course of business-to-business activity, namely: import, local sales, export, authorized representatives (i.e. registrants) who place devices on the local market, and local manufacture of medical devices.

b) Conditions and obligations on licensees

Certain conditions and obligations will be imposed on the licensees. These include compliance with standards (e.g. good manufacturing practice, good distribution practice), the mandatory requirement for distribution records, and the establishment of procedures for handling product recalls and adverse events involving their products. These measures are essential to ensure that products can be traced and swift corrective actions can be taken even after a product has entered the Singapore market. They also reflect the continuing responsibility of all licensees to ensure that the products they market remain safe and of good quality.

c) Restriction on access to certain types of devices

There will be controls restricting access to certain types of medical devices that are more complicated and potentially harmful when used wrongly or inappropriately, so that such devices are only supplied to and used by qualified persons (e.g. doctors).

The proposed framework imposes pre-market controls and controls on labelling, advertising and promoting medical devices.

a) Pre-market controls

Pre-market controls will require that only devices which meet requirements of safety, quality and performance are allowed to be sold in Singapore. All medical devices must bear proper product labels which reflect the permitted claims on the intended use of the device, as well as instructions for use. All devices would need to be registered with HSA prior to entering the Singapore market.

b) Controls on advertisement and sales promotion

HSA will set out the circumstances under which advertising and marketing are permitted, to curb any false or misleading advertisement claims inconsistent with the safety, quality and intended uses of the product as registered, and promoting the appropriate and safe use of the product. An advertiser promoting a medical device with false or misleading claims may be penalised by requiring him to publish a corrective advertisement, in addition to the usual penalties imposed by the Court.

c) Singapore Medical Device Register

Consumers and healthcare purchasers of medical devices can consult an online register containing a list of medical devices registered with HSA and legally available for sale in Singapore. This register will also contain information on the brand-owner, local authorised representative, distributor and intended use of a device.

The proposed framework also envisages exemptions from product registration and licensing requirements, and special access to unregistered medical devices, which will be provided under certain circumstances, for example, in the case of investigational devices for clinical trials and custom-made devices ‘manufactured' solely for use by a particular patient.