Newsletter

INDONESIA: POST MARKET TESTING OF MEDICAL DEVICES – OCTOBER/NOVEMBER 2023

INDONESIA: POST MARKET TESTING OF MEDICAL DEVICES – OCTOBER/NOVEMBER 2023

  • 2023-10-20 07:21:15

In September 2023, a circular letter issued by Indonesia’s Ministry of Health recommended that distributor license owners conduct post-market testing independently on circulated products. Products with submitted independent post-market test results which are within qualifications will receive a priority benefit in the e-Katalog system.

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MALAYSIA: MDA ANNOUNCED MANDATORY PROBLEM REPORTING REQUIREMENTS UNDER ACT 737 AND RULE 2019 − OCTOBER/NOVEMBER 2023

MALAYSIA: MDA ANNOUNCED MANDATORY PROBLEM REPORTING REQUIREMENTS UNDER ACT 737 AND RULE 2019 − OCTOBER/NOVEMBER 2023

  • 2023-10-20 06:51:30

The Medical Device Authority (MDA) announced on 19th September that any event involving registered medical devices that occurs outside of the country is not required to be reported to MDA if the incident has been notified to the regulatory agency in the country where the incident happened and corrective action or precautions have been taken by the manufacturer or establishment.

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QT ACTIVITY: QT JAPAN WEBINAR SUMMARY – SEPTEMBER/OCTOBER 2023

QT ACTIVITY: QT JAPAN WEBINAR SUMMARY – SEPTEMBER/OCTOBER 2023

  • 2023-09-27 07:52:28

Qualtech's webinar on medical device registration in Japan highlighted the critical aspect of reliability inspection. Key topics covered include the registration process, PMDA's role, and the requirements of the reliability inspection. The webinar provided valuable insights into this complex process, facilitated by expert speakers from Qualtech.

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