Singapore Health Sciences Authority has updated the Guidance for Industry: Product Defect Reporting and Recall Procedures for Therapeutic Products and Cells, Tissue and Gene Therapy Products (CTGTPs). The main updates
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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 device – SaMD) that take effect from 25 February 2021.
read more...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.
According to the Health Products (Cell, Tissue, and Gene Therapy Products)
read more...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 No 2018-002: “Guidelines Governing the Issuance of an Authorization for
read more...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 order for applicants to understand and comply with regulations properly
read more...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 Products Clinical Changes Technical Guidelines”, and “Chemicals Changes Acceptance and
read more...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 Labels and Package Inserts of Medical Devices B.E. 2563 [2020]
read more...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 Products was revised by the State Administration for Market Regulation,
read more...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, the Department of Health of Hong Kong decided that under
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