Australia TGA Published Regulatory Changes for Software Based Medical Devices
Australia TGA published a summary of regulatory changes to the regulation of software-based medical devices (including software as a medical …
Singapore Implements New Regulations for Cell, Tissue, and Gene Therapy Products (CTGTP)
Singapore implements new regulations for cell, tissue, and gene therapy products (CTGTP). The regulations take effect from 1 March 2021. …
Philippines FDA Issues Implementation Schedule and Guidelines on Standards for Medical Devices
The Philippines FDA issued Circular no. 2021-002 on 4th January 2021, which contains the implementation schedule of the Administrative Order …
Vietnam MOH Issues Official Letter to Guide the Preparation of Applications for Medical Device Registration
The letter states that the Ministry of Health has received, processed, and appraised applications for medical device registration and in …
CDE of China Issues Guidelines for Drug Information Changes
The Center for Drug Evaluation (CDE) released the “Marketed Chemicals Pharmaceutical Changes Study Technical Guidelines (Trial)”, “Marketed Chemicals and Biological …
Thailand’s New Notification Regarding Rules, Methods and Condition for Display of Labels and Package Inserts of Medical Devices 2020
On 22 September 2020, Notification of the Thai Ministry of Public Health Re: Rules, Methods and Condition for Display of …
China Revises the Provisions for Lot Release of Biological Products
Pursuant to the new Vaccine Administration Law and the revised Drug Administration Law, the Provisions for Lot Release of Biological …
Hong Kong Department of Health (DoH) to Enhance Regulatory Control of Skin Antiseptic Products
To safeguard public health in the safe and proper use of all skin antiseptic products containing substances other than chlorhexidine, …
China’s NMPA Signs MoU on Regulatory Cooperation with Italian Medicines Agency
China’s NMPA signs MoU on regulatory cooperation of medicines, medical devices, cosmetics with Italian Ministry of Health, Italian Medicines Agency. …