Correction action of medical devices is included in the eRPS. The structure of the online submission dossier of corrective action is provided.
More 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
More
Qualtech's big topic article for this month's edition represents an overview of the recent and upcoming changes implemented in the ASEAN countries of Southeast Asia. We thereby cover 6 ASEAN countries and review the most critical and noteworthy changes, so that our readers remain up-to-date and can take required actions in a timeline manner.
More The Japanese MHLW has issued a complimentary notice to explain further about cybersecurity of the Essential Principles Requirements.
More
If you would like to know more about these aspects and many more important regulatory information for the ASEAN markets, you may join Qualtech's ASEAN Regulation Update Webinar on 28 April 2023 (Friday) at 16:00 p.m. – 17:30 p.m. (GMT+8).
More 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.
More 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.
More A Presidential Decree No. 6/2023 concerning Halal Certification for Drugs, Biological Products and Medical Devices, which is based on Government Regulation No 39/2021 concerning Halal Product Implementation, is issued. This decree will further regulate the halal implementation of medical devices in Indonesia.
More 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.
More Decree 07/2023/ND-CP dated March 3, 2023, of the Vietnamese Government amends and supplements several articles of the Government's Decree No. 98/2021/ND-CP dated November 8, 2021 on medical device management.
MoreWe collect your browsing history through cookies to understand how you use our website to analyze and improve your experience. By continuing to use our website, you accept our use of cookies.
