The Health Sciences Authority Singapore has published updates to the guidance document titled ‘GN-21: Guidance on Change Notification for Registered Medical Devices Revision 4.9’. This guidance document takes effect on 25 April 2022. The main update in this revision is about ‘Change in Design and/or Specifications of General Medical Devices’
All Class B, C and D medical devices that are already in the Philippine market prior to the effectivity of FDA Circular 2021-002-A may continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without CMDN shall be extended until 31 March 2023. The Food and Drug
First edition guidance on the classification of rehabilitation, physiotherapy, and speech therapy devices was issued by the Ministry of Health Malaysia on 22 April 2022. The Medical Device Authority (MDA) published the guidance document to outline the terms and definitions of rehabilitation, physiotherapy, and speech therapy. This provides manufacturers and
The Philippines Food and Drug Administration (FDA) seeks comments from the Medical Device Industry regarding new draft guidelines that could provide faster registration processing and approval should the medical device qualify for the abridged route. Advisory 2021-3084 was issued last November 18, 2021: Abridged Processing of Application for registration/notification of
The purchase of self-test kits for COVID-19 requires providing personal information at sales premises authorized by MDA and KPDNHEP, and the collection of this information is a growing concern among buyers. MDA is aware of the concerns among users and would like to clarify that the requirement to record this
Singapore’s Health Sciences Authority published new updates to the guidance document titled ‘Guidance on Special Access Route (SAR) Rev 2’. The announcement is part of HSA’s effort to strengthen regulatory oversight on the importation and local use of unregistered high-risk medical devices requested by qualified practitioners or public healthcare facilities.
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