Singapore: Revision of GN-21 on impact related to CE marking

There have been some changes in the Singapore Health Science Authority (HSA) regulations to promote quicker access to the registration of certain medical devices and mobile applications while giving device makers more clarity. HSA plans to exempt some devices from registration requirements according to their risk and other factors, including the approval attained for the device by other international regulators and its length of time in the market.

To apply for medical device registration, the format of the applications must be in accordance with the one set out in the ASEAN Common Submission Dossier Template (CSDT) document. This template is generalized for manufacturers who wants to place their device in the ASEAN market. The information that needs to be provided under each section depends on the risk class of the device and the evaluation route.

As of 1 June 2018, registration of Class A sterile devices will not be necessary. However, they would need to appear on the entity’s online Class A database and comply with post-market surveillance requirements. Some Class B devices may use the immediate registration route, where the device will be immediately registered upon submission.

For the Class B device to qualify for immediate registration, they would need to have no association with safety issues globally and is either approved by 2 other reference regulators or be approved by only 1 reference regulator and be in the market for a minimum of 3 years in that country. The following are reference regulators recognized by the HAS:

1. US Food and Drug Administration

2. EU notified bodies

3. Australia’s Therapeutic Goods Administration

4. Health Canada

5. Japan’s Ministry of Health, Labor, and Welfare

Immediate registration can also be done for mobile medical applications that are under Class B and Class C. It must have approval by at least 1 reference agency, with no known safety issues.

With these criteria, HSA states that qualification for immediate access route will be open to ¾ of Class B devices.

Source:

Guidance on Change Notification

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