HSA medical device regulations

14 May 2012

Question No. 185

Name of person: Associate Prof Fatimah Lateef

Question

To ask the Minister for Health (a) whether the Ministry will review the regulatory steps and paperwork load involved in the regulation of medical devices; (b) whether measures can be implemented to assist SMEs and smaller companies in filing their applications for approvals of medical devices; and (c) whether the Ministry will consider entering into Mutual Recognition Agreements with overseas agencies such as the US Food and Drug Administration and Health Canada.

Answer 

1        The Health Sciences Authority (HSA) adopts a risk-based approach aligned with international best practice in the regulation of medical devices, and subjects riskier and more complex devices to more rigorous scrutiny and review.

2        Medical devices approved by any one of the reputable reference agencies (the US Food & Drug Administration, Health Canada, the European Union, Japan’s Ministry of Health, Labour and Welfare and Australia’s Therapeutic Goods Administration) undergo an abridged evaluation with a shorter review time and lower registration fee. About 98% of applications are expected to be able to use this route.  For abridged evaluation, only summary documents of the quality, pre-clinical and clinical data as well as certifications need to be provided instead of the full dataset.

3        In response to further feedback from industry and the medical profession, HSA announced several measures to streamline its regulatory processes on 20 April 2012. 

4        From 1 May 2012, all lowest risk Class A devices except sterile devices have been exempted from product registration, accounting for 80% of Class A device types. As they are exempted from registration, there is no need for companies to submit supporting documents for HSA’s review and approval.

5        From 1 September 2012, moderately low risk Class B medical devices will have two additional faster access routes: (a) 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 3 years, and (b) an expedited registration route for devices approved either by 2 independent reference agencies but without the 3 year safety record, or only one of the reference agencies and marketed in that jurisdiction or Singapore without safety concerns for at least 3 years. This will positively impact 3,500 or 85% of current Class B applications received.

6        This approach is also being studied for Class C and D device approvals before the end of the year. The fees for low cost, low volume devices brought in through the Special Authorisation Routes are also being reviewed by 1 August 2012.  

7        To address issues faced by SMEs, HSA is in discussion with industry associations to assist companies through a ‘concierge service’ to help conduct pre-submission consultations and screen the completeness of dossier applications. A Dossier Submission E-Guide was launched on HSA’s website on 20 April to provide companies with step by step advice on dossier submission.

8        Mutual recognition agreements are difficult to implement because of the adjustments needed to legal regimes and requirements for participating countries. It is also desirable to maintain some independence of regulatory assessments for higher risk medical devices. Hence to achieve the same objective of expediting  the approval of device applications, HSA has established memoranda of understanding (MOUs) and confidentiality agreements with its counterparts overseas to share confidential reports on product evaluation and leverage on reference agencies’ approval to minimise duplication.  The MOUs include those with the US FDA, Health Canada, Australia’s TGA and Japan’s product evaluation agency.