• 2020-02-12 15:00:06

Slight revision on guidance documents about Singapore Standards and Medical devices for exhibition were added last July 2018.

• 2020-02-12 16:01:31

HSA aims in improving the existing regulations related to product registration to benefit both product owners and locals. In June of 2018, HSA published new regulations on Telehealth products and Devices for Aesthetic purposes.

• 2020-02-13 06:13:18

Health Sciences Authority announces changes to the regulatory process for medical devices, including faster market access for lower risk devices, clearer regulatory controls for De novo device and high risk device, strengthen Post-market measures. 

• 2020-02-14 04:08:31

Outcomes of these consultation sessions have been consolidated and new revisions to the existing guidance documents and issuance of new guidance documents are to be carried out in stages, after this.

• 2020-02-12 16:02:17

Health Sciences Authority (HSA) published the list of new fees applicable to health products including Medical devices, on last August 1, 2018.

• 2020-02-14 07:28:51

HSA held a briefing in order to present key proposal changes in the existing regulation. The said event focused on six proposed key changes to current medical device regulations.

• 2020-02-15 06:31:28

HSA has finalized the Guidelines for Telehealth Products. Telehealth products refer to "instruments, apparatus, machines or software involved in the provision of healthcare services over physically separate environments via information communication technologies."

• 2020-02-15 06:30:30

HSA drafted Guidance 34 for IVD Analyzers, to address the concerns of product owners and registrants with IVD analyzers and their associated accessories. GN-34 is “intended to act as a ‘one-stop’ document for IVD analyzers”.

• 2020-02-15 06:41:57

The Medical Device Branch of the Health Products Regulation Group of Health Sciences Authority (HSA) launched two schemes which came into effect starting August 1st 2017.

• 2020-02-15 09:10:35

Qualtech TFDA manager is invited to be the speaker in Singapore seminar "Understanding Taiwan's Regulatory Framework for Medical Devices" organized by Singapore Manufacturing Federation and DH RegSys Pte Ltd.