Singapore Despite its small size and population (4.7 million people) compared to most other Asian c

Singapore
Despite its small size and population (4.7 million people) compared to most other Asian countries, Singapore also has a highly developed medical device sector, boasting a market size of $500 million.
Medical devices are classified into four classes in Singapore, based on how they are intended to be used and the risks that may arise from their use. The Health Sciences Authority (HSA) of Singapore decided to lower regulatory requirements for Class A and Class B medical devices, which have lower risks and account for almost 70 percent of medical device use in the tiny city-state. The new requirements will speed up the market entry process of these lower-risk medical devices.

At present, it is mandatory that devices with the lowest risks—Class A—be registered before entering Singapore. However, beginning in May this year, only sterilized Class A devices must be registered before they are marketed. The time needed to process the approval will be shortened to 30 working days. For unsterilized Class A devices, the $25 registration fee no longer is required. Nevertheless, in order to allow for post-market surveillance and monitoring, importing companies and manufacturers still are required to declare all Class A medical devices in their licenses.

Starting in September, the registration procedures for Class B medical devices also will be accelerated. If a device has been on the market for at least three years without any safety issues and has been approved by at least two major international regulatory bodies (for example the U.S. Food and Drug Administration; Japan’s Ministry of Health, Labor and Welfare; European Union Notified Bodies, Health Canada and Australia’s Therapeutic Goods Administration), it will receive immediate approval from the HSA.

If a device has been approved by two of the aforementioned agencies but has not been marketed in Singapore without safety concerns for at least three years, its registration time will be shortened to 60 days. The same expedition will be given to devices that have been approved by only one of the aforementioned agencies but have been marketed in Singapore for at least three years without any safety issues. For both immediate and expedited approvals, the registration fee will be lowered from $2,300 to $1,400.

The HAS also introduced a simplified classification system with fewer tiers for small, low-cost medical devices that are approved by the GN-27 Special Authorization Route. Starting this August, the HAS also will lower application fees and lengthen the timeframe for which the approval is valid from two months to one year.