On 22 May 2018, the Health Sciences Authority (the "HSA") issued a press release announcing changes to the regulatory process for medical devices ("MDs"). The changes include:

  • Faster market access for lower risk MDs;
  • Clearer regulatory controls for newer MDs (e.g. telehealth devices) and higher risk MDs; and
  • Greater emphasis on post-market measures.

The changes, effective 1 June 2018, are a result of extensive consultation with the medical industry.

Faster market access for lower risk MDs

In Singapore, the regulatory review process differs depending on the risk classification of the MDs. The risk classification system is as follows:

  • Class A - low risk;
  • Class B – low to moderate risk;
  • Class C – moderate to high risk; and
  • Class D – high risk.

In light of the changes, certain lower risk MDs will be qualified for immediate entry into the market:

MDs

Registration

Class A sterile MDs

None required; however, importers/manufacturers are required to list their products on a public database to demonstrate that they have complied with requisite standards on sterility.

Class B MDs that have (i) no safety issues associated with the device globally; and (ii) 2 independent regulatory agencies' approval or 1 reference agency's approval plus 3 years of marketing history.

Qualified for immediate registration.

Class B and C standalone mobile medical applications that have been approved by at least 1 reference agency without safety issues globally.

Qualified for immediate registration.

Clearer regulatory controls regarding newer and higher risk MDs

The Health Products (Medical Devices) Regulations will also be amended in the following ways:

  • It will align with HSA's recent guidelines on telehealth devices regarding when telehealth devices would be regulated as MDs.
  • It will clarify that high risk devices used for modification of appearance or the anatomy (e.g. implants, invasive devices for fat removal) are subject to regulatory controls. A Positive List setting out which products are regulated will be included.
  • It will require manufacturers of complex devices (that require users to possess special skills and knowledge to operate such devices) to provide appropriate trainings to the users.

Greater emphasis on post-market measures

The HSA will strengthen post-market surveillance, which includes checking and monitoring of product compliance in Singapore and close monitoring of adverse events overseas, in order to detect safety issues early.

Comments

The changes demonstrate the HSA's shift to focus more on newer and higher risk MDs and less on lower risk MDs that have been tried and tested in other countries. This is a strategic move as advancement in technology allows for more innovative MDs (e.g. telehealth devices) which could also have greater safety risks. Further, it seems that the HSA will be taking on a more proactive post-market surveillance role which will likely also focus on newer and higher risk MDs. All in all, these changes demonstrate the HSA's recognition that the regulations have to keep apace with technological advances.