On 4 November 2020, the Hong Kong Department of Health has issued a new version of Guidance Notes: GN-01 Overview of the Medical Device Administrative Control System.
This document gives an
Regulatory News
Q&A on Implementation of Chinese Pharmacopeia 2020
The Chinese Pharmacopoeia Commission has published a Q&A on the Implementation of 2020 Chinese Pharmacopeia on 30 September 2020. The Chinese Pharmacopoeia comes into effect on 30 December 2020.
https://www.pharmatomarket.com/chinese-pharmacopoeia-2020-draft-approved-by-the-chinese-pharmacopoeia-commission/
The answers
NMPA issues a Circular on the Registration of Medical Devices for Urgent Clinical Needs
This circular, dated 29 October 2020, specifies measures related to the review and approval of medical devices for urgent clinical needs. Such devices are to be used for the treatment
Malaysia MDA Launches New Version of Search System MEDICAL DEVICE AUTHORITY REGISTER for Registered Medical Devices and Licensed Establishments
On 4th November 2020, the Medical Device Authority of Malaysia issued an announcement to announce that the old PBPP Search System known as Public Search – Malaysia Medical Device Register
South Korea MFDS issues 3 Q&As relating to GMP, Official Communication Channel , Drug Approvals and other topics
South Korea Ministry of Food and Drug Safety (MFDS) has issued 3 Q&As in late-November/early-December 2020 relating to GMP, Official Communication Channel , Drug Approvals and other topics:
2020 MFDS
Australia TGA Issued a New Version of Priority Applicant Guidelines for Medical Devices (including IVDs)
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
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
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
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