Recent Requirement to Certify Medical Devices

Dr Lam Pin Min asked 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.

Mr David Ong asked 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 ensure that the registration would not be time-consuming, costly and cumbersome in light of the large number of medical devices requiring registration.

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Ms Tin Pei Ling asked 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.

The Minister of State for Health (Dr Amy Khor Lean Suan) (for the Minister for Health): Sir, with your permission, may I take Question Nos 19 to 21 together?

Mr Speaker: Yes, please.

Dr Amy Khor Lean Suan: 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 five 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.

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

From 1 September this year, 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 and marketed in those markets without safety concerns for at least three years. The second is an expedited registration route for devices approved either by two independent reference agencies but without the three-year safety record, or only one of the reference agencies but with the three-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.

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. 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 HAS's approval. Class B invasive devices related to TCM practice such as acupuncture needles, acupoint 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.

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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 minimise errors and delays.

Ms Tin Pei Ling has asked about annual certification under the Good Distribution Practice for Medical Devices in Singapore (GDPMDS). 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 three-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.

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

Dr Lam Pin Min (Sengkang West): I would like to thank the Minister of State for the reply. I would like to ask the Minister of State the following supplementary questions: (i) what is the extent of the backlog of the devices for certification by HSA; and how long would it take for these to be cleared; (ii) will MOH consider publishing the expected approval times for the various classes of devices ranging from Class A, B, C and D so that medical practitioners and institutions can plan accordingly; and (iii) will MOH consider waiving the need to evaluate devices that already approved by reputable agencies, such as the US FDA?

Dr Amy Khor Lean Suan: I thank the Member for his questions. Firstly, for the backlog: for Class A devices, as I have noted earlier, since 1 May 2012, we have exempted non-sterile Class A devices. So, the remaining 900 applications for sterile devices will be cleared in the next one and a half months. For Class B, out of 4,300 applications we have received, we have cleared about 50% of the applications and by 1 September with the implementation of the immediate and expedited registration route, 80% of the remaining will be cleared by the end of the year. For Class C and D, we have cleared 90% of the applications and the remaining applications will be cleared in the next six months.

HSA would continue to review and streamline our regulatory process as well as increase its capacity to deal with the significant number of applications. We would also be looking into extending the enhanced approach for low risk Class B devices to Class C and D devices, taking into account approval by reference agencies, market safety records as well as increased emphasis on post-marketing surveillance. We will be announcing any changes by the end of this year for Class C and D devices.

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As regards the turnaround time: the estimated turnaround time for the different risk classes of devices are actually published on the HSA website but, with the enhancements to the regulatory framework for Class A sterile devices which still need registration, the turnaround time would be reduced from 60 working days to 30 working days. For Class B devices, for the group that will not qualify for immediate registration but is under the expedited route, the turnaround time would be reduced from 100 working days to 60 working days, effective from 1 September 2012.

As regards why not just approve medical devices that have already got approval from other reference agencies, with the enhanced measures, in effect for low risk Class B devices that have got approval from at least two reputable reference agencies as well as a three-year market safety record, they effectively would be registered immediately. For those that do not comply with this but have got approvals from two reference agencies without market safety record or one reference agency with a market safety record, they would go through the expedited route.

We have chosen to take this route based on our experience from the initial roll-out of the medical device regulation as well as feedback and experience from reference agencies. In fact, the medical device regulatory framework is not as established worldwide as the drug regulatory framework. And gaps have actually been identified even from the US and EU systems and there have been increasing calls for these systems to be tightened. So, we have chosen to adopt this approach which balances between our need to ensure patient safety as well as facilitating access to medical devices.

Ms Tin Pei Ling (Marine Parade): I thank the Minister of State for the comprehensive reply. I am very happy to note that MOH is considering stratifying different medical devices further. I am sure that would assuage some of the concerns that the TCM practitioners and even the SMEs that import some of these medical devices have. Can I just ask if MOH will consider engaging some of these TCM practitioners and TCM SME importers on the kind of medical devices that they have, the range of devices that they have because some of them actually have got some local innovations. And these, therefore, may not conveniently fall into certain categories that we commonly observe. I think this would be helpful for them because as small practices, these recent changes in terms of registration of devices have inflicted a certain amount of stress on them. So, hopefully, with the engagement, this will also help allay some of the concerns that they have.

Dr Amy Khor Lean Suan: In fact, when HSA implemented the medical device regulation, it adopted a phased approach from 2007 till this year, and that really is to help the industry transit into a regulated framework. It has actually engaged the medical profession as well as the medical device suppliers, including many SMEs and TCMs. We will continue to engage, particularly, the SMEs and TCMs medical device suppliers to help them to transit into this regulatory framework.

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Mr David Ong (Jurong): Mr Speaker, I would like to ask Minister of State Amy Khor whether Singaporeans armed with a doctor prescription are allowed to go across the Causeway and enjoy alternative price and product options for their healthcare needs. And, if it is "yes", what is the quantum or restriction? If it is "no", why deny them the option of a cheaper healthcare cost?

Dr Amy Khor Lean Suan: I presume the Member is talking about medical devices as well as drugs. I think some Singaporeans are already doing this. It is a personal decision. but for drugs under the Medicines Act, with a doctor's prescription and if the quantity does not exceed three months, that would be all right. But, really, I think the law caveat emptor would apply too.

Mr Speaker: Assoc Prof Fatimah Lateef, last question.

Assoc Prof Fatimah Lateef (Marine Parade): Sir, besides the time issue, there has been a lot of feedback from players in the industry that the paper work is extremely tedious in the application process. I was wondering if HSA and MOH would be reviewing the paper work, especially since this is tedious for smaller companies that do not have so many departments and personnel to look into this paper work.

Dr Amy Khor Lean Suan: HSA has put on its website a dossier submission E-guide to help particularly the SMEs in the submission of the dossier. In fact, they can get HSA to make any clarifications, if required, free of charge. For the GDPMDS certification process, HSA has also put up guidelines for the GDPMDS requirements and sample documents such as the master file on its website, and companies can follow that. Again, HSA also holds consultation for companies if they need clarifications on the GDPMDS processes and it is also free of charge. HSA is now also working with industry associations like the Singapore Manufacturers' Federation on concierge services, which means that they would work with them so that they can provide companies with support, submission consultation as well as checking on the completeness of dossier submission to minimise errors and delays.