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
Regulatory News
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
Singapore HSA Updates Medical Device Guidance GN-20: Guidance on Clinical Evaluation
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
Singapore HSA Publishes New Regulatory Guidelines for Laboratory Developed Tests (LDTs)
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
Philippines FDA Publishes Circular on The Abridged Processing of Medical Devices Registration With Approval by The NRA of Any ASEAN Member Country
Philippines FDA issues Circular No. 2022-008 on 27th September 2022, aims to provide guidelines on the abridged processing of applications for registration of medical devices with product approval issued by
China NMPA Extends Drug Submission Time for Supplementing Materials
On October 14th, China’s National Medical Products Administration (NMPA) announced an extra 80 to 160 days extension for the submission of drug supplementary dossiers to China’s Center for Drug Evaluation
Hong Kong DOH Updates the List of Refence Countries for Registration of Pharmaceutical Products
Hong Kong’s Pharmacy and Poisons Board reviewed the requirements of the list of reference countries for the registration of pharmaceutical products containing new chemical or biological entity (NCE).
Effective 1st November