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USA: Final Premarket Notification (510(k)) Submissions Guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheter – June/July 2023

USA: Final Premarket Notification (510(k)) Submissions Guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheter – June/July 2023

  • 2023-06-28 07:24:11

The Food and Drug Administration (FDA) has recently released guidance aimed at streamlining the premarket notification (510(k)) submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters. This guidance provides manufacturers and FDA staff with comprehensive recommendations to ensure regulatory compliance and enhance the safety and effectiveness of these medical devices

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China: NMPA's Announcement on the Implementation of GB 9706.1-2020 and Related Collateral Standards and Specialized Standards (No. 14 of 2023) – April/May 2023

China: NMPA's Announcement on the Implementation of GB 9706.1-2020 and Related Collateral Standards and Specialized Standards (No. 14 of 2023) – April/May 2023

  • 2023-04-25 02:06:51

GB 9706.1-2020 <Medical electrical equipment - Part 1: General requirements for basic safety and essential performance > was announced on 9th April 2020 and has been put into effect from 1st May 2023 onwards. The interpretations and relevant information are provided and have been briefly summarized in this article.

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MALAYSIA: MDA Announced the Second Edition on Classification of Rehabilitation, Physiotherapy and Speech Therapy Devices – April/May 2023

MALAYSIA: MDA Announced the Second Edition on Classification of Rehabilitation, Physiotherapy and Speech Therapy Devices – April/May 2023

  • 2023-04-25 01:40:47

The MDA published the Second Edition Guidance Document, “Classification Of Rehabilitation, Physiotherapy And Speech Therapy Device” (MDA/GD/0061), on March 08, 2023. This document is directed to give manufacturers and authorized representatives (AR) an appropriate guideline on the classification of rehabilitation, physiotherapy, and speech therapy products. This guidance document classifies a number of products used for rehabilitation, physiotherapy, and speech therapy as medical devices or non-medical devices respectively, based on the manufacturer's stated intended purpose.

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PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

  • 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

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