Newsletter

Post-market surveillance Services

Post-market surveillance Services

  • 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

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MALAYSIA: Revision introduced to the circular letter on post-market responsibilities for manufacturer and authorized representative - December, 2019

MALAYSIA: Revision introduced to the circular letter on post-market responsibilities for manufacturer and authorized representative - December, 2019

  • 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.

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[ANALYSIS] What to know about China’s post-market surveillance – December, 2019

[ANALYSIS] What to know about China’s post-market surveillance – December, 2019

  • 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.

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