HSA Medical Device Registration

What is a Medical Device?

“Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, 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

(a) diagnosis, prevention, monitoring, treatment or alleviation of any disease;
(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
(c) investigation, replacement, modification, or support of the anatomy or of a physiological process;
(d) supporting or sustaining life;
(e) control of conception;
(f) disinfection of medical devices; or
(g) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body,

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.

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 the 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.

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.

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:
• • Listed on the Singapore Medical Device Register (SMDR);
  • Listed on the transition lists; OR
  • Authorised via one of the Authorization route.

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 SMDR;
• Listed on the transition list; OR
• Authorised via one of the Authorization routes.