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...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...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...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,
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...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
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
The National Pharmaceutical Regulatory Agency (NPRA) Malaysia has published the first edition of the “Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection” in March 2022.
The objective of this
read more...The Health Sciences Authority (HSA) Singapore has published the latest guidance document on special access routes (SAR), that provide a pathway for unregistered medical devices to be brought into Singapore,
read more...The Health Sciences Authority (HSA) Singapore has published some guidelines regarding the labelling standards of traditional medicines (TM) and health supplements (HS) in March 2022.
The objective of these guidelines is