Medical devices have become an increasingly important health care area in relation to their impact on health and health care. Medical devices cover over 8000 types of products, ranging from simple bandages, walking stick, contact lenses, wheelchair, through life maintaining implantable devices, equipment to screen and diagnose diseases and health conditions (example pregnancy test kit), to the most sophisticated diagnostic imaging and minimal invasive surgery equipment
What is a Medical Device?
“Medical device” --
(a) means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purposes of--
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease;
(ii) diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;
(iii) investigation, replacement, modification, or support of the anatomy or of a physiological process, mainly for medical purposes;
(iv) supporting or sustaining life;
(v) control of conception;
(vi) disinfection of medical devices; or
(vii) providing information by means of in vitro examination of specimens derived from the human body, for medical or diagnostic purposes,
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means; and
(b) includes the following articles:
(i) any implant for the modification or fixation of any body part;
(ii) any injectable dermal filler or mucous membrane filler;
(iii) any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.
What is not a Medical Device?
In general, medical device is intended to be used to achieve a medical function (including diagnostic, preventive or therapeutic). But it does not achieve its primary intended function by pharmacological, immunological or metabolic action.
Hence products that are not intended for use in preventing, diagnosing, curing or alleviating diseases, ailments, defects or injuries are not medical devices. Some examples of products that are not medical devices include, body toning equipment, magnetic accessories, etc.
Consumers should exercise judgement in evaluating the benefits and possible risks when using such products. When in doubt, consumers should always seek the advice of their trusted family doctors.
Classification of Medical Devices
Medical devices may be classified into 4 risk classes.
|Class||Risk Level||Device examples|
|A||Low Risk||Surgical retractors / tongue depressors|
|B||Low-moderate Risk||Hypodermic Needles / suction equipment|
|C||Moderate-high Risk||Lung ventilator / bone fixation plate|
|D||High Risk||Heart valves / implantable defibrillator|
Classification of a medical device will depend upon a series of factors, including:
- How long the device is intended to be in use
- Whether the device is invasive
- Whether the device is implantable
- Whether the device is active
- Whether the device contains a drug or biologic component
The classification rules are adopted from the guidance developed by the Global Harmonization Task Force.
Exempted Medical Devices
Regulatory controls for medical devices are based on the risk associated with the use of the devices. Certain low risk medical devices, due to the low risk associated with their use, are exempted from product registration. These medical devices are exempted for specific intended purpose as listed in our GN-22 Guidance to the list of medical devices exempted from product registration. These devices can be immediately supplied to the market without going through the product registration.
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.
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.
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.
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.
Phase 3 Implementation
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:
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.