MDA Malaysia Publishes Updated Circular on Conformity Assessment Procedures for Medical Device Approved by Recognised Countries
The Malaysian Medical Device Authority (MDA) has published an updated circular regarding the conformity assessment procedures for medical devices approved by recognised countries, …
Australia TGA Publishes Guidance Document on Classification of Active Medical Devices
Therapeutic Goods Administration (TGA) Australia has published the first version of the guidance document on the classification of active medical devices (including software-based medical devices) in October 2021. The guidance document will …
MDA Malaysia Publishes Updates on Establishments Acting as Authorized Representatives and Establishments Carrying Out Different Activities
The Malaysian Medical Device Authority (MDA) has revoked Circular Letter No. 1/2014 that contains two components, namely establishments acting as authorized representatives (AR) and establishments carrying out …
Singapore HSA Publishes Updated Document on Technical Reference for Product Registration Submission for General Medical Devices
The Health Sciences Authority (HSA) Singapore has published an updated document on medical device technical reference, focusing on the contents of a product …
NPRA Malaysia and MDA Malaysia Issues Updated Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products
National Pharmaceutical Regulatory Agency (NPRA) Malaysia and Medical Device Authority (MDA) Malaysia have issued an updated guideline, which is the …
Australia TGA Publishes Guidance Document on Reclassification of Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems
Therapeutic Goods Administration (TGA) Australia has published a guidance document on the reclassification of medical devices in direct contact with the heart, central circulatory system (CCS) and central nervous …
Australia TGA Publishes Updated Guidance Document on Medical Device Patient Information Leaflets and Implant Cards
Therapeutic Goods Administration (TGA) Australia has published an updated guidance document on medical device patient information leaflets (PIL) and implants cards (including acceptance of Implementation Plans) in October 2021. The …
Singapore HSA Publishes Document on Common Questions for Generic Drug Applications
The Health Sciences Authority (HSA) Singapore has published a document on the common questions received for Generic Drug Applications in September 2021. The document highlights …
NPRA Malaysia Issues Updated Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guideline on clinical trial import licence (CTIL) and clinical trial exemption (CTX) in September 2021. The updated guideline …