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
Regulatory News
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
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
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)
Singapore HSA Reviewed and Validated Medical Device Guidance Document Remains Valid
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
Singapore HSA Announces Upcoming Regulatory Updates for Cosmetic Products
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
Access Generic Medicines Work-Sharing Initiative
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
Singapore HSA Updates GN-06: Guidance on Distribution Records for Medical Devices
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