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:
The changes, effective 1 June 2018, are a result of extensive consultation with the medical industry.
In Singapore, the regulatory review process differs depending on the risk classification of the MDs. The risk classification system is as follows:
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 |
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. |
The Health Products (Medical Devices) Regulations will also be amended in the following ways:
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.
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.
This article is produced by our Singapore office, Bird & Bird ATMD LLP, and does not constitute legal advice. It is intended to provide general information only. Please contact our authors if you have any specific queries.