Malaysia MDA implement first edition guideline on “How To Submit An Application For Registration Of A Refurbished Medical Device (MDA/GL/10), January 2023”.
This guideline document was prepared by the Medical Device
read more...Malaysia MDA implement first edition guideline on “How To Submit An Application For Registration Of A Refurbished Medical Device (MDA/GL/10), January 2023”.
This guideline document was prepared by the Medical Device
read more...HSA strives to complete the screening of the new and major variation applications in the shortest possible time. For the new and major variation applications accepted within the period of
read more...Singapore MOH has updated the “MOH Clinical Justifications Form for Class D SAR Application” for the GN-26 and GN-27 SAR for unregistered medical devices:
a. GN-26: For licensed Qualified Practitioner (QP)
Singapore HSA reviewed several Medical Device Guidance Documents which were not updated since June 2018, and confirmed that the content for these guidance documents remain valid on 1 Nov 2022.
Below
read more...Singapore Health Sciences Authority (HSA) sent an email to industry stakeholders, announcing that there will be upcoming amendments to the Health Products (Cosmetic Products – ASEAN Cosmetic Directive) Regulations with
read more...The Therapeutic Goods Administration (TGA) Australia has released further information on the Generic Medicines Work-Sharing Initiative. It is an innovative work-sharing model for the coordinated assessment of generic applications filed
read more...HSA has included “ISO 13485:2016” in defining the projected useful life of a medical device.
Product owners may refer to ISO 13485:2016 – Medical devices – A practical guide, for some
read more...HSA has specified “ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects” in GN-20: Guidance on Clinical Evaluation, as a benchmark to the industry that clinical investigations are
read more...Laboratory Developed Tests (LDTs) are in vitro diagnostic tests (IVDs) that are:
• developed and manufactured within a licensed clinical laboratory and solely for use within the same laboratory where it