• 2022-03-25 11:51:14

Software as Medical Device (SaMD) is rapidly developing and frequently updating its compatible hardware. In order to ensure the safety, performance, and quality of SaMD while keeping in line with international standards, TFDA has released a guideline regarding post-market change application of SaMD.

• 2021-03-22 07:09:05

In Malaysia, Post-Market Surveillance and Vigilance (PMSV) is regulated under the Medical Device Act 2012 (Act 737) and Medical Device (Duties and Obligations of Establishment) Regulations 2019. In this edition of QT Analysis, tag along with us to keep updated on the latest PMSV requirements in Malaysia.

• 2020-11-09 10:51:43

Post-market surveillance has become an inexorable trend around the globe.
Therefore, proactively collect and track the following information of your products is essential and crucial.
-Relative post-market incidents reported (e.g. alerts, AEs, recalls)
-Relevant clinical literatures

• 2020-02-21 06:59:18

MDA has introduced a revision to the Circular Letter No 1 of Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative. This Ciruclar Letter essentially discusses all the duties and obligations which fall upon local manufacturers and local authorized representatives, after placing devices on the market.

• 2020-02-21 06:52:42

Recently on November 13, NMPA had issued a notice on the suspension and rectification of a domestic manufacturing factory,, instructing the manufacturer to stop production until rectification is completed and approved by NMPA. On the other hand, nearly 30 manufacturers (domestic and foreign) initiated voluntary recalls of their products in November. Similar news has been cropping up in recent year, and it’s foreseeable that NMPA will keep strengthening the surveillancein the future.

• 2020-05-06 08:30:49

Data still reflects rampant product recalls and occurrence of adverse events, indicating that products sold in the market are not safe as regulators think. This has prompted Health Agencies to develop a comprehensive PMS System.

• 2020-05-06 07:52:16

All locally marketed medical devices must have their post-market activities continuously monitored until their projected useful life expires. If the current AR or manufacturer go out-of-business, it is their responsibility to find replacement to take care of this or continue monitoring.

• 2020-02-12 14:22:55

At the end of August, the China Market Supervision Administration (the leader institute of NMPA) has officially published the “Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices”.