• 2024-09-17 02:45:43

Medical devices often undergo numerous iterations to enhance the product based on real-world experience and feedback. These changes result in rebranded new products called Next Generation Medical Devices (NextGen MD). Health Sciences Authority (HSA) in Singapore has taken a proactive step by introducing the NextGen MD Initiative to facilitate the registration of next generation devices by streamlining the registration process to allow applicants to leverage data that has been submitted to HSA for registered devices.

• 2024-06-20 05:49:36

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) This means manufacturers with existing HSA approvals can now use them to support their applications for registration in Hong Kong, potentially saving significant time and resources.

• 2024-06-19 06:31:24

Starting 13 May 2024, Hong Kong Medical Device Division has excluded non-clinical devices from Medical Device Administrative Control System’s scope. Custom-made medical devices have also been excluded from this scope since 2 April 2024, and marketing approvals from Health Sciences Authority - Singapore has been accepted to support listing applications.

• 2023-07-21 02:32:25

Singapore's Health Science Authority (HSA) is pleased to announce their status as a recognized Stringent Regulatory Authority (SRA) for Class C and D IVD by WHO. The SRA status means high-risk IVD products registered with HSA might obtain faster evaluation through WHO prequalification assessment, enabling manufacturers accelerated access to global markets.

• 2023-01-19 02:06:31

The Singaporean Health Sciences Authority (HSA) has updated the regulatory guidelines for Laboratory Developed Tests (LDTs) based on the feedback from the stakeholders for the draft that was published for consultation last July 12 - August 12, 2022. The finalized version is coded as GL – 08 R1 with the title of “Regulatory Guidelines for Laboratory Developed Tests (LDTs)”and will be effective on March 1, 2023.

• 2022-08-30 03:46:38

HSA Medical Devices Cluster (MDC) shared a draft guideline for the regulation of Laboratory Developed Tests (LDTs). The regulation’s scope includes laboratories that develop In Vitro Diagnostic (IVD) devices. HSA requests stakeholders to provide comments for further discussion.

• 2022-02-18 09:04:53

Health Sciences Authority (HSA) issued a list of COVID – 19 test kits that are authorized for professional use. These kits have been given authorization under the Pandemic Special Access Route (PSAR) because Professional Use Only (PUO) kits have been designated as “emergency medical devices”.

• 2022-02-18 08:51:05

Health Sciences Authority (HSA) addresses issues about the creation of new Product Owners (PO) by applicants even though there is an existing one. HSA shares the steps in changing the PO ID number via Change Notification. HSA reminds applicants to search first for the existing PO ID before creating a new one.

• 2021-11-24 03:19:40

A golden opportunity has opened for manufacturers or importers to shorten the duration of Medical Device Registration of those under Class4 with Thailand FDA and HSA Singapore Regulatory Reliance.

• 2021-08-02 04:41:50

HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.