TGA has issued a new version of priority applicant guidelines for medical devices (including IVDs)
The purpose of these guidelines is to assist applicants seeking a conformity assessment (priority applicant) determination
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Taiwan’s Guidance on Registration of Artificial Intelligent / Machine Learning-Based Software as a Medical Device (AI/ML-Based SaMD)
The Taiwan Food and Drug Administration has released a guideline pertaining to the application of artificial intelligence related to medical devices which are aimed at medical device manufacturers.
This guidance is
read more...Australia has Declared that Certain Sports Supplements are Therapeutic Goods
The TGA, has made a legislative instrument. The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020 (“the Amendment Order”) to help protect Australian consumers from the unsafe use of
read more...Singapore HSA to implement Medical Device Unique Device Identification (UDI) system
The Medical Devices Branch had organized a webinar on the Medical Device (MD) Unique Device Identification (UDI) System in Singapore on 19 October 2020 to provide an introduction to Unique
read more...Australia TGA changes ARTG Inclusion Process for Non-Measuring, Non-Sterile Class I Medical Devices
From 1 October 2020, the process by which the TGA includes Class I non-measuring, non-sterile medical devices in the Australian Register of Therapeutic Goods (ARTG) has changed. These changes do
read more...Singapore HSA Published Document Relating to Change Applications Arising from the EU MDR/IVDR related changes to registered medical devices
With EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR), the related changes will impact existing registered medical devices, especially IFU and labels. This document
read more...Philippines FDA adopts the WHO Collaborative Registration Procedure (CRP) for the Accelerated Registration of WHO Prequalified Pharmaceutical Products and Vaccines.
This Administrative Order is issued to establish an accelerated review process for prequalified pharmaceutical products and vaccines, through the adoption of the WHO CRP into the national registration procedures and
read more...Thailand FDA issued an Announcement on Regulations, Procedures and Conditions for Providing Academic Documents for Medical Devices
The announcement was issued to confirm the standards of quality, efficacy and safety for medical devices for review by or for submission to the authorities upon request and to protect
read more...South Korea Releases New Law on Advanced Regenerative Medicine and Advanced Biopharmaceuticals
The Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act (abbreviation is “Advanced Regeneration Bio Act.”) and the subordinate Enforcement Decree became effective as of 28 August 2020.
The Enforcement