The HSA will also enhance its post-marketing surveillance activities to mitigate risks associated with expedited pre-market approval of devices. This includes ensuring compliance to stipulated standards, promoting adverse event reporting, detecting unregistered devices early and stepping up enforcement activities against dealers who contravene the legislation.

"The HSA is mindful to ensure that the cost of medical device regulation does not significantly impact the overall healthcare cost even as the regulations continue to ensure patient safety. The HSA will continue to refine our regulatory framework and further stratify its fee structure, especially for certain low-cost medical devices with a low volume demand," comments an HSA spokesperson who did not want to be identified.

These enhancements are applicable to all local, regional and global dealers intending to manufacture or place their medical devices in the Singapore market.

HSA categorization for medical devices

Medical devices in Singapore are categorized in four segments, from simple to complex, as Class A, B, C and D. Class D devices are sophisticated diagnostic imaging equipment or cardiac stents and are subject to tighter regulations.

For example, Class A includes reusable surgical forceps for grasping tissue, Class B includes single-use, sterile forceps for grasping tissue, Class C includes electrosurgical forceps or instruments for coagulation of tissue and vessels and Class D includes neurological forceps or instruments for neurological procedures.

• The HSA has exempted all Class A devices from registration, except for sterile devices
• For Class B medical devices, the HSA will implement the Immediate Registration and Expedited Registration Route from September 1, 2012
• For the Immediate and Expedited Registration routes, the regulatory fees will be reduced from $1,799 to $1,095 
• The HSA is looking into a low-tiered fee structure for its Special Authorisation Route for existing and innovative, low-cost and low-volume medical devices