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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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China: CFDA releases the interpretation of the basic requirements of the clinical evaluation for IVD reagents exempt from the clinical trials - December 2017

China: CFDA releases the interpretation of the basic requirements of the clinical evaluation for IVD reagents exempt from the clinical trials - December 2017

  • 2020-02-14 15:22:02

The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.

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 MALAYSIA: Circular Letter Recognizing IMR Malaysia As A Credible Source To Provide Clinical Evaluation Data for Clinical Trials Conducted in Malaysia - November 2017

MALAYSIA: Circular Letter Recognizing IMR Malaysia As A Credible Source To Provide Clinical Evaluation Data for Clinical Trials Conducted in Malaysia - November 2017

  • 2020-02-15 06:20:38

A new Circular Letter was released by Medical Device Authority (MDA) on October 2, 2017, in which MDA recognizes Institute of Medical Research (IMR) Malaysia as a credible source to provide clinical evaluation data for conformity assessment purposes conducted by a Conformity Assessment Bodies (CAB) in Malaysia. This Circular Letter comes into effect starting October 2, 2017.

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