The Health Sciences Authority (HSA) Singapore has published an updated version of the guidelines for software medical devices (MD) in April 2022.
One of the updates is under the pre-market product
Regulatory News
Philippines FDA Updates Circular on Transition Period for Certificate of Medical Device Notification
The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2021-002-B, an amended version of Circular No. 2021-002-A. This is an addendum to Circular No. 2021-002, which contains
read more...Singapore HSA Publishes Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software
The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on the determination of risk classification of standalone medical mobile applications that are medical devices, which
read more...MDA Malaysia Issues First-Edition Document on Classification of Devices
The Malaysian Medical Device Authority (MDA) has published the first edition of a guidance document on the classification of products involved in rehabilitation, physiotherapy, and speech therapy in April 2022.
The
read more...Medsafe New Zealand Publishes Updates on Regulation of Therapeutic Products
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has issued the second version of the guideline on the regulation of therapeutic products in February 2022, and the document
read more...Singapore HSA Publishes Regulatory Updates for Therapeutic Product Registration
The Health Sciences Authority (HSA) Singapore has provided a list of the latest regulatory updates for therapeutic product registration in April 2022.
The changes include revised checklists for post-approval minor variations,
Singapore HSA Publishes Guidelines on Safety of Ingredients for Traditional Medicines and Health Supplements
The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on the establishment of ingredients’ safety for traditional medicines (TM) and health supplements (HS) in March
read more...Australia TGA Publishes Latest Guidance on Medical Device Patient Information Leaflets and Implant Cards
The Therapeutic Goods Administration (TGA) Australia has published the latest version of the guidance document on patient information materials (patient implant cards and patient information leaflets) in March 2022.
One notable
Singapore HSA Publishes Guidelines for Manufacturing Standards of Traditional Medicines and Health Supplements
The Health Sciences Authority (HSA) Singapore has published the first version of the guidelines on manufacturing standards of traditional medicines (TM) and health supplements (HS) in March 2022.
Manufacturers are required