• 2020-06-11 10:06:42

PFDA issues FDA Circular No. 2020-016 to remind public that online sale of approved COVID-19 test kits is prohibited. Furthermore, the kits are for medical professional use only. PFDA urges law enforcement as well as the public to be vigilant regarding COVID-19 test kits in the market.

• 2020-05-12 07:00:43

Health Sciences Authority (HSA) ensures the availability of test kits for the detection and diagnosis of COVID – 19. For these devices, a provisional authorization process is implemented, which can be done via email and be responded by HSA within three (3) working days.

• 2020-07-31 09:31:11

The announcement aims to set a standard and to ensure the direction for the authority in performing an evaluation of HIV screening kit by self-test application.

• 2020-05-06 07:09:04

The regulations of examination for testing institutions in China have been changing for the past 2 years. Currently the State Administration for Market Regulation (SAMR) plans to re-organize the structure of testing centers, from solely permitting official institutions to now also opening up the procedure to public 3rd-party testing organizations.

• 2020-05-06 06:48:33

Currently the State Administration for Market Regulation (SAMR) plans to re-organize the structure of testing centers, from solely permitting official institutions to now also opening up the procedure to public 3rd-party testing organizations.

• 2020-02-12 14:17:57

The update guidance includes "risk classification", "licensing of manufacturer", "Field safety corrective action", product registration"... and other registration related documents.

• 2020-02-13 06:24:58

According to rule 19 of the Medical Device Rules 2017, the central government may establish “Central Medical Devices Testing Laboratories” for the purpose of

• 2020-02-14 04:13:25

The regulatory standards for the approval of IVD devices keep on changing time to time because of the continuous improvements and modifications made related to their better performance level. There was a revision for “glucometer test strips” in 2013 as mentioned in IS/ISO 15197: 2013.

• 2020-02-14 07:40:37

In light of the new Medical Device Rules 2017, CDSCO/CLA/SLA shall have updated information of laboratories involved in testing of medical device & in vitro diagnostics with respect to their laboratory reports and decision on performance evaluation of products made by stakeholder/regulator.