HSA Introduces Regulation Of Medical Devices In Phases
Posted on Thursday, October 11, 2007 - 08:00 PM
The Health Sciences Authority (HSA) will be implementing the regulation of medical devices in phases from 1 Nov 2007. Medical devices are the first category of health products to be regulated under the Health Products Act.
BACKGROUND
2. The Health Products Act, which was passed by Parliament in February 2007 and assented to by the President on 1 March 2007, enables HSA to implement a risk-based regulatory framework, which allows for varying degrees of controls to be applied to the different product categories.
3. In respect of medical devices, the range of products available in Singapore has been growing in diversity and complexity. At the same time, more lay persons are increasingly using medical devices. With these trends, the risks associated with medical devices are likely to increase over time and it is therefore timely to formally regulate medical devices under the Health Products Act to enhance safeguards for patients and consumers.
4. In February 2007, HSA launched an 8-week public consultation on the proposal to regulate medical devices. HSA also held extensive briefings and dialogue sessions with the device industry, healthcare professionals, Consumer Association of Singapore (CASE) and the Advertising Standards Authority to gather their views. The feedback received was considered in mapping out the regulatory framework for medical devices.
PHASED-APPROACH TO REGULATE MEDICAL DEVICES
5. Medical devices cover a wide range of products, from syringes to artificial hearts with varying risk profiles. In formulating the medical device regulations, HSA applied the concept of risk management to keep the level of regulation proportional to the degree of risk involved in using a medical device.
6. HSA is adopting a phased approach in implementing the new regulations to minimise the impact to the supply of medical devices and to provide sufficient time for the industry to meet the new standards and requirements. The control measures will be implemented in three phases, starting from 1 November 2007:
| Phase |
Regulatory Measures |
Benefits to Consumer |
Phase 1
From 1 Nov 2007 |
Duties and Obligations on Dealers
(i) Mandatory reporting on adverse events to HSA
(ii) Mandatory product recalls upon HSA’s instructions
(iii) Mandatory reporting on product recalls as instructed by manufacturers
(iv) Legal obligation to keep complaints and distribution records
(v) Legal obligation to submit documents and products for testing upon HSA’s instructions |
Strengthened post-market monitoring and surveillance |
Phase 1
From 1 Nov 2007 |
Advertisement & Promotion Monitoring
(i) Action and penalty against fraudulent advertisements
(ii) Publish corrective advertisement for any offending advertisement |
More objective information to allow consumers to make informed decisions. |
Phase 2
1 Apr 2008 – 1 Oct 2009 |
Licensing of Dealers
(i) Licensing of dealers* of medical devices |
Enhanced quality of medical devices throughout the supply chain, providing better protection of consumers from unsafe and/or poor quality products. |
Phase 2
1 Apr 2008 – 1 Oct 2009 |
Product Registration
(i) Registration of medium and high-risk medical devices
(ii) Registration of low-risk medical devices |
Exclusion of devices that do not meet standards of safety and performance, providing better protection of consumers from unsafe and/or poor quality products. |
Phase 3
1 Oct 2009 and 2010 |
Implementation of Regulations
(i) Prohibition against unlicensed parties dealing with medical devices
(ii) Prohibition against supply of unregistered medium and high-risk medical devices
(iii) Prohibition against supply of unregistered low-risk medical devices (effective 1 October 2010) |
Better protection of consumers from unsafe and/or poor quality products.
|
*Dealers include manufacturers, importers and wholesalers
7. Upon completion of the licensing and registration of all dealers, it will be illegal to manufacture, import or supply unregistered medium and high-risk devices from 1 October 2009 and low-risk products from 1 October 2010.
CALL TO MEDICAL DEVICE DEALERS
8. HSA will be conducting further trade briefings to update medical device dealers on the latest development. The next briefing will be held on 17 October at HSA Auditorium, Outram Road. Dealers who wish to attend the briefing can register by contacting HSA’s Centre for Medical Device Regulation at Tel: 68663560 or email HSA_CMDR_Info@hsa.gov.sg .
9. HSA also encourages medical device dealers who have not attended any previous trade briefings on the regulation of medical devices, to come forward and contact HSA for information on the impending regulations.
HEALTH SCIENCES AUTHORITY
11 OCTOBER 2007
May 17, 2008 - 06:38 PM
Public Access
