6 days agoAustralia: New Vaping Legislation Effective from 1 July 2024Australia introduces new legislation, The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024, to regulate the...
7 days agoSingapore: "NextGen MD Initiative" for Next Generation Medical Device Registrations (w.e.f 1 July 2024)“NextGen MD Initiative” was introduced by the Health Sciences Authority (HSA) on 13 June 2024 to facilitate the registration of...
Jul 3Hong Kong: New Screening Protocol Introduced for Registration Application of Pharmaceutical Products/Substances (w.e.f 1 July 2024)The Pharmacy and Poisons Board of Hong Kong (“the Board”) announced that the Refuse-to-File (“RTF”) Mechanism will be enforced in the...
Jul 2Thailand: Thai FDA Streamlines Medical Devices Registration Pathway (w.e.f 6 June 2024)Effective 6 June 2024, the Thailand Food and Drug Administration (TFDA) has executed the new announcement on the registration...
Jun 26Hong Kong: Medical Gases Endorsed as Pharmaceutical Products (w.e.f 14 June 2026)Overall responses from full and thorough jurisdictions based on the current situation in Hong Kong and public consultation led by the...
Jun 25India: New Self-Declaration Requirement Implemented for Pharmaceuticals & Medical Device Associations (d.d 30 June 2024)On the 28th and 30th of May 2024, the Department of Pharmaceuticals of India released 2 Standing Orders regarding the new...
Jun 19Australia: TGA Adopts PIC/S Guide to GMP Version 16: Manufacturing Principles for Medicines, APIs & Sunscreens (w.e.f 3 September 2024)On 3 June 2024, the Therapeutic Goods Administration (TGA) amended its Therapeutic Goods (Manufacturing Principles) Determination...
Jun 18Malaysia: MDA Revokes Compliance Assessment Process Exemption for COVID-19 Test Kit RegistrationThe Medical Device Authority (MDA) released an announcement on 31 May 2024 about the revocation of the MDA Circular Letter...
Jun 12France: ANSM Designates AFNOR as the Newest Notified BodyMedical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...