Singapore’s Health Sciences Authority (HSA) recently implemented a new phase in their updates to Singapore’s medical device regulatory framework. This phase brings Singapore a step closer to a mandatory registration system for medical devices. Singapore’s system will also eventually be implemented in all of the member countries of the Association of Southeast Asian Nations (ASEAN).
In Singapore, the ASEAN Common Submission Dossier Template (CSDT) is now accepted as the format for medical device submissions. The previous format, under the Voluntary Product Registration Scheme (VPRS), will only be acceptable until April 30, 2009. From May 1, 2009 onwards, only product registration applications in the CSDT format will be accepted for review.
The HSA recently announced the fee schedule for medical device registration in the new system. The fees are generally based on the risk classification of the product. The application fee for registering a Class A device is $25. The application fee for Class B, C, and D devices is $500. The evaluation fee is due after the HSA screens the dossier to check that its classification and submission route are appropriate, but before the HSA will begin reviewing the dossier. Evaluation fees range from $1400 to $4600 for abridged submissions of Class B, C, and D devices, or from $2400 and $8000 for full submissions of Class B, C, and D devices. The HSA estimates that 80% of devices will qualify for abridged submission. Devices normally qualify if they have existing market approval in the US, EU, Canada, Japan, or Australia.
Additionally, applications that are received between November 1, 2008 and October 31, 2009 will be eligible for special “incentive” product evaluation fees. These special evaluation fees will be reduced by about 30% for full submissions and by about 20% for abridged submissions.
The HSA has also released an estimated timeframe for product application review. These are target times, but they are not guaranteed. For full-submission Class B devices, total approval time is estimated to be around 120 working days; for Class C devices, around 180 working days; and for Class D devices, around 270 working days. Review times will generally be 60 to 90 days shorter for devices with abridged instead of full submissions.