Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can download the Medical Device Registration Certificate from MeDC@St2.0+ system once
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Singapore HSA Updates Guidance on Unregistered Therapeutic Product Import and Supply
In March 2023, HSA updated Guidance on Import and Supply of An Unregistered Therapeutic Product For Patients’ Use.
See Pharma To Market insider: https://www.pharmatomarket.com/singapore-hsa-updates-unregistered-therapeutic-product-import-and-supply-guidance-and-forms/?utm_source=rss&utm_medium=rss&utm_campaign=singapore-hsa-updates-unregistered-therapeutic-product-import-and-supply-guidance-and-forms
Minor revision was made by HSA to the
read more...Malaysia MDA Issued Guideline on Notification of Custom-Made Medical Device
Malaysia MDA issued the first edition guideline on Notification of Custom-Made Medical Device (MDA/GD/0064) on 28 February 2023.
This guidance document specifies requirements and notification process for the applicant to obtain
read more...Singapore HSA Updates Unregistered Therapeutic Product Import and Supply Guidance and Forms
Singapore HSA Updates Guidance TPB-GN-004-005 regarding the Import and Supply of an Unregistered Therapeutic Product For Patients’ Use.
HSA includes the conditions for using the “named-patient” special access route as following:
a)
Singapore HSA Enhances Medical Device Change Notification Process
Singapore HSA has enhanced the Change Notification application process for Medical Device online platform (MEDICS) that will come into effect from 7 March 2023.
HSA’s Medical Device guidance GN-21: Guidance on
Singapore HSA Updates Guideline on Voluntary Notification System for Health Supplements and Traditional Medicines
HSA recently reviewed the newly implemented notification process, and HSA updated the Guideline on Voluntary Notification System for Health Supplements and Traditional Medicines.
Updates to the guideline are as following:
– Companies
Malaysia MDA Implement Guideline On How To Submit An Application For Registration Of A Refurbished Medical Device
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...Singapore HSA Shares Statistic on HSA’s Mean Screening Time and Applicant’s Mean Screening Response Time For New Application and Major variation Applications
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 Ministry of Health (MOH) Extends Special Access Routes (SAR) Review Timeline and Updates MOH Clinical Justifications Form for Class D SAR Application
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)