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MALAYSIA: New Guideline Document MDA/GL/08: Re-Registration Of Registered Medical Devices – July 2022

MALAYSIA: New Guideline Document MDA/GL/08: Re-Registration Of Registered Medical Devices – July 2022

  • 2022-07-26 11:19:48

The Medical Device Authority (MDA) published a guideline document to provide information and explanation to establishments on how to submit a re-registration of registered medical device applications in Malaysia. The document prescribes the requirements for re-registration of registered medical devices for medical device registration applications that are about to expire or have already expired.

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China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration  (Revised Edition 2022)

China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration (Revised Edition 2022)

  • 2022-04-27 11:16:17

NMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.

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China: Two Guidelines for Registration and Review of Drug-Device Combination Products Mainly Functioning as Medical Devices – February, 2022

China: Two Guidelines for Registration and Review of Drug-Device Combination Products Mainly Functioning as Medical Devices – February, 2022

  • 2022-02-18 08:10:07

Drug-device combination products that mainly function as medical devices (referred to as drug-device combination medical devices in this guideline) are expected to make prevention and treatment of diseases more effective, but may also lead to new technical concerns. Therefore, NMPA formulated two guiding principles to further guide the applicant's preparation for the registration application for drug-device combination medical devices, and to encourage the innovative development of such products.

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CHINA: Medical Device Clinical Trial Data Submission Requirements for Registration Review Guidelines-No. 91 in 2021 – January, 2022

CHINA: Medical Device Clinical Trial Data Submission Requirements for Registration Review Guidelines-No. 91 in 2021 – January, 2022

  • 2022-01-26 08:31:11

Clinical trial data is one of the important supporting documents for evaluating the safety and effectiveness of medical devices. Standardizing the collection, sorting, analysis, and submission of medical device clinical trial data will not only improve the quality of clinical trial implementation and management but also assist the regulatory agency to understand and review the development of clinical trials quickly and efficiently.

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QT Webinar: Japan Medical Device Registration

QT Webinar: Japan Medical Device Registration

  • 2021-09-06 06:11:51

Qualtech Consulting would like to invite you to our free online Webinar on the subject of "Japan Medical Device Registration". Our event is scheduled to be held on September 17th (Friday), 2021.

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