Faster Market Pathway in Effect for Higher-Risk Devices in Singapore
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has set up expedited registration routes for higher-risk Class C and D devices in the country beginning January 1, 2013 in order to improve public access to new medical technologies. Similar expedited registration routes were launched by the HSA in 2012 for lower-risk Class A and B devices.
There are some exclusions to the new policy, however. Some types of long-term implantable devices, device-drug combination products and high-risk diagnostic testing products do not qualify for expedited review.
Class C Expedited Route
Class C medical devices that qualify for expedited HSA evaluation must have prior approval from at least two of the regulator’s reference agencies (the US FDA, Health Canada, European Notified Bodies, the Australian TGA and/or the Japanese PMDA), or prior approval from one reference agency with no reported safety issues for at least three years.
According to the HSA, average review times for qualifying devices will decrease from 160 business days to 120 business days, and registration costs will be reduced by $500. Singaporean regulators anticipate that three quarters of all current Class C device applications will qualify for expedited review.
Class D Expedited Route
In order to qualify for the HSA expedited review, Class D devices must have been approved by at least two reference agencies prior to registration in Singapore. Average review times for qualifying Class D applications will decrease to 180 working days from 220, and regulatory fees per application will fall by $300. The HSA expects about half of all current Class D applications to qualify for the expedited route.
New QMS requirements for dealers and wholesalers
Along with the new expedited Class C and D registration pathways, Singaporean authorities have set up a tiered quality management system requirement for importers and wholesalers dealing in Class A medical devices. These entities previously had to obtain Good Distribution Practice for Medical Devices in Singapore (GDPMDS) certification as well as comply with renewal and auditing requirements; now, Class A importers and wholesalers will have to meet less onerous quality system requirements by submitting HSA QMS assessment forms and annual QMS compliance declarations, which will reduce these firms’ documentation by 30% and allow them to bypass GDPMDS certification fees.
Regional regulatory implications
Beyond the near-term effects of a more streamlined and efficient medical device registration process in Singapore, the HSA's new policies will likely also influence how other regional market regulators in the Association of Southeast Asian Nations (ASEAN) economic group develop and revise their own rulemaking ahead of a planned harmonized regulatory framework across 10 countries including Singapore in 2014.