HSA medical devices

14 May 2012

Question No. 353

Name of person: Dr Lam Pin Min

To ask the Minister for Health (a) whether the Health Sciences Authority will look into speeding up the certification process of medical devices without compromising on safety; and (b) how will the Ministry ensure that the implementation of the regulation on medical devices do not result in unnecessary excessive medical cost to the patients.

Question No. 358

Name of person: Mr David Ong

To ask the Minister for Health (a) whether the requirement to register all medical devices will result in a spiralling up of healthcare costs; (b) how will his Ministry ensures that the registration would not be time-consuming, costly and cumbersome in light of the large number of medical devices requiring registration.

Question No. 423

Name of person: Ms Tin Pei Ling

To ask the Minister for Health in light of the refinements made to the registration of medical devices (a) how have such refinements cushioned the financial and administrative impact on TCM practitioners and SMEs who import medical devices used in the practice of Chinese medicine; (b) what other measures will be taken to assist them further; and (c) whether the Ministry will consider allowing the certification for Good Distribution Practice for Medical Devices (GDPMDS) to be renewed over a longer period of time instead of annually. 

Answer

1        HSA regulates medical devices to ensure consumer and patient safety.  In doing so, HSA has to strike a balance between ensuring patient safety and facilitating access to medical devices.  In line with international best practice, HSA has implemented a risk-stratified approach, subjecting riskier devices to more rigorous scrutiny and review. This was implemented in phases over the last 5 years since 2007. Devices which were already being used in Singapore were included in the Transition-List so that access to these devices would not be affected even as their registration was being processed.

2        On 20 April 2012, HSA announced enhancements to the medical device regulatory framework to facilitate easier and expedited access for lower risk (Class A and B) medical devices as well as a reduction of the registration fees to reflect the simpler process.    

3        All Class A devices except sterile devices were exempted from 1 May 2012.  2,700 more product types are now exempted in addition to the 2,000 exempted in January.  In all, 80% of Class A device types are exempted.  Furthermore, approvals for sterile devices with the CE mark are now expedited. 

4        From 1 September 2012, moderately low risk Class B medical devices will have two additional faster access routes. The first is an immediate registration route for devices approved by any two of HSA’s independent reference agencies[1] and marketed in those markets without safety concerns for at least 3 years.  The second is an expedited registration route for devices approved either by two independent reference agencies but without the 3 year safety record, or only one of the reference agencies but with the 3 year safety record either in that jurisdiction or Singapore.  The combined enhancements for Class B device clearance should positively impact 3,500 or 85% of current Class B applications received.  HSA is also looking into the potential extension of this approach using reference agencies, safety history and greater post-marketing measures to enhance Class C and D device approvals before the end of the year.

5        These enhancements also cover medical devices used in TCM practice. The majority of devices used in TCM practice fall under the low risk Class A category while more invasive products are categorised as moderately low risk Class B devices.

6        Class A devices used for TCM practice include dermal rollers, vacuum suction cups and traction devices. Due to the exemption from product registration, dealers can import these products for TCM use without obtaining HSA’s approval.

7        Class B invasive devices related to TCM practice such as acupuncture needles, acupoints and nerve stimulator devices  can be immediately registered or go through the expedited registration pathways if they meet the criteria for these accelerated approvals. Both the immediate registration and expedited registration route come with lower registration fees and documentation requirements.

8        HSA is also working with industry associations such as the Singapore Manufacturers’ Federation to provide more support to SMEs in general to meet regulatory requirements, for example through better dossier submissions. This will minimize errors and delays.

9        Ms Tin Pei Ling has asked about annual certification under Good Distribution Practice for Medical Devices in Singapore, or GDPMDS for short.  I would like to clarify that the GDPMDS certificate for medical device importers and wholesalers is issued by certification bodies accredited by the Singapore Accreditation Council (SAC), and is actually valid for a 3 year period and not just for one year. However, in accordance with international ISO practice, an annual site audit is required to ensure compliance with stipulated standards which assure the quality and integrity of products throughout its distribution process. 

10                We are mindful to ensure that the cost of medical device regulation does not significantly impact the overall healthcare cost even as we endeavour to enhance patient safety. The fees for low cost, low volume devices brought in through the Special Authorisation Routes are being reviewed to facilitate access to these devices. This is targeted for implementation on 1 August 2012.   HSA will further stratify its fee structure for low cost, low volume devices. In the case of GDPMDS, importers can explore consolidating their importation activities with companies which are GDPMDS compliant. The fees charged for medical device regulation is a one-time cost for the entire life of the device in the market. There are yearly renewal fees but these currently range from $25 for a Class A to $120 for a Class D device. Hence, the impact of the regulatory fees on healthcare cost is expected to be small in most instances.

11      MOH will continue to work with HSA to monitor the impact of regulatory costs on medical devices and review the fees.

[1] US Food & Drug Administration, Health Canada, European Union/Australian Therapeutic Goods Administration and Japan Ministry of Health, Labour & Welfare