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CHINA: CNDA has Released a New Catalogue of Medical Devices to Be Exempted from Clinical Trials (Draft) – July 2018

CHINA: CNDA has Released a New Catalogue of Medical Devices to Be Exempted from Clinical Trials (Draft) – July 2018

  • 2020-02-14 03:59:43

In early June, CNDA had issued a draft consisting of the fourth batch of medical device catalogues to be exempted from clinical trials along with the revisions of the first three batches of catalogues, in able to catch up with the upcoming classification to be implemented in July. In this regard, CNDA is currently accepting comments from the public until the end of June 2018.

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MALAYSIA: Raminder Notice on the Complete Enforcement of Requirements for Registration of Medical Device - July 2018

MALAYSIA: Raminder Notice on the Complete Enforcement of Requirements for Registration of Medical Device - July 2018

  • 2020-02-13 06:23:56

MDA has released a Circular Letter at the end of May 2018 as a reminder notice on the complete enforcement of requirements for registration of medical device under Section 5 of Medical Device Act 2012 (Act 737), whereby no medical device can be allowed to be imported, exported or marketed in Malaysia unless it has been registered with MDA, according to this Act.

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