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USA: US FDA's eSTAR Program – March/April, 2023

USA: US FDA's eSTAR Program – March/April, 2023

  • 2023-03-27 08:22:41

The US FDA starts to launch the so-called "eSTAR" Pilot with Health Canada. The eSTAR is an interactive medical device submission process and is expected to likely become the main path regarding medical device submissions for 510(k) and De novo registrations in the near future.

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QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

QT Activity: Summary of Qualtech's Webinar on the EU MDR Updates from February 7, 2023 – February/March 2023

  • 2023-02-23 02:33:41

Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.

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China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

  • 2023-02-23 02:05:29

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".

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INDONESIA: Expansion of E-purchasing Access for Private Health Facilities Participating in the JKN (National Health Insurance Scheme) – February/March 2023

INDONESIA: Expansion of E-purchasing Access for Private Health Facilities Participating in the JKN (National Health Insurance Scheme) – February/March 2023

  • 2023-02-23 01:39:29

The Procurement Bureau of the Ministry of Health and the National Public Procurement Agency plan to expand E-purchasing access for private health facilities participating as National Health Insurance (in Indonesia known as JKN) providers for transactions of medical devices in the e-katalog starting from January 2023.

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MALAYSIA: MDA Announces New Guideline On How to Submit an Application for Registration of A Refurbished Medical Device – February/March 2023

MALAYSIA: MDA Announces New Guideline On How to Submit an Application for Registration of A Refurbished Medical Device – February/March 2023

  • 2023-02-23 01:35:01

The Medical Device Authority (MDA) published the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10) on January 11, 2023. The MDA created this guidance document to assist the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its regulations.

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