Currently, only contact lens care products, radiation emitting devices and condoms come under statutory control through certain provisions in the Medicines Act and Radiation Protection Act.
- See Current Legislative Controls for more information.
- Get more information on the proposed regulatory framework.
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Regulatory Controls for Medical Devices
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.
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Implementation of Regulatory Controls
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.
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Phase 1 Implementation
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.
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Phase 2 Implementation
From 1 November 2008, HSA has started accepting applications for licensing of dealers of medical devices and registration of medical device products.
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Phase 3 Implementation
The last phase of the implementation will be conducted in 2 stages:
From Stage 1:
- Unlicensed manufacturing, importation and wholesaling of medical device is prohibited
- Supply of unregistered Class B, C, and D medical devices is prohibited
From Stage 2:
- Supply of unregistered Class A medical devices is prohibited
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