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USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

  • 2022-06-29 03:18:32

The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing. The concept comes from the Medical Device Innovation Consortium (MDIC), which assesses the capability and performance of key business processes using a maturity appraisal model tailored to the medical device industry. The overall stated goal is to enhance the quality processes and to improve the overall medical device quality, as to ultimately ensure better patient treatment outcomes.

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PHILIPPINES: PFDA Shared CMDN Requirement Extension and Drafts for Abridged Route and Emerging COVID-19 products – May 2022

PHILIPPINES: PFDA Shared CMDN Requirement Extension and Drafts for Abridged Route and Emerging COVID-19 products – May 2022

  • 2022-05-26 13:57:18

PFDA extended the CMDN Requirement of Class B-D Non-Registrable products until March 2023. This will allow continue selling of the affected products in the country using a License to Operate as the requirement. In addition, PFDA shared draft regulations pertaining to the earlier released Abridged Route Evaluation and COVID-19 products using new technologies.

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THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

THAILAND: Thai FDA released Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device – April, 2022

  • 2022-04-27 11:27:43

In correspondence with the risk-classification implementation for recent period starting from mid-February 2021 onwards, Thailand Food and Drug Administration has ultimately publicized the Guidance on Change Notification for Listing Medical Device, Notified Medical Device and Licensed Medical Device, which has been effective since 1st March 2022.

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USA: Low-Risk Novel Products Can Avoid Automatic Class III Designation from US FDA – March, 2022

USA: Low-Risk Novel Products Can Avoid Automatic Class III Designation from US FDA – March, 2022

  • 2022-03-25 11:58:47

The US Food and Drug Administration (FDA) has updated several regulations affecting De Novo classification of novel medical devices. The main purpose is to present an objective and balance for the scientific evidence to be the foundation to grant a De Novo request. Also, the De Novo products will serve as future predicate devices for prospective 510(k) registration applications to improve and extend the existing 510(k) database.

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USA: FDA Transition Plan for Emergency Use Authorizations (EUAs) Medical Devices – February, 2022

USA: FDA Transition Plan for Emergency Use Authorizations (EUAs) Medical Devices – February, 2022

  • 2022-02-18 09:37:25

The US FDA is planning to issue transition plans for medical devices with Emergency Use Authorizations (EUAs). The EUA measure had previously been implemented in order to increase related necessary medical product supply on the US market.
As the Coronavirus Disease 2019 (COVID-19) pandemic gradually slows down, FDA has published a draft guidance to provide its recommendations to manufacturers, and in order to outline a roadmap for EUA devices to be able to transition after the emergency use declarations are no longer in effect in the future.

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