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QT Activity: CLINICAL EVALUATION REPORT (CER) SERVICES

QT Activity: CLINICAL EVALUATION REPORT (CER) SERVICES

  • 2021-06-24 02:55:03

We are happy to announce that Qualtech offers extensive services for Clinical Evaluation Report (CER) writing! Shall a CER be of interest for your business, please refer to the information within. Feel free to contact us for a first consulting session on this matter!

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MALAYSIA: Circular Letter No 3 Year 2018: Recognition and Listing of Institute or Laboratory Which is Capable to Carrying Out Clinical Evidence or Performance Evaluation for the purpose of Conformity Assessment - July 2018

MALAYSIA: Circular Letter No 3 Year 2018: Recognition and Listing of Institute or Laboratory Which is Capable to Carrying Out Clinical Evidence or Performance Evaluation for the purpose of Conformity Assessment - July 2018

  • 2020-02-13 06:21:59

Medical devices to be registered in Malaysia must first undergo conformity assessment with a Conformity Assessment Body, to demonstrate its conformity to the requirements of medical device law. In regards to this, currently there are conformity assessment service with good quality and also comparable to global assessments or test carried out by local laboratories.

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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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