JNM Global

Global Approval Partner

2024/07 6

Australia TGA, updates distribution record keeping and storage

The Australian Therapeutic Goods Administration (TGA) has updated its medical device distribution record requirements from 23 May 2024. Under section 41FO of the Treatment Supplies Act 1989, sponsors of medical devices supplied and exported from Australia must keep the following distribution record.Expedite any recalls of the medical devices.Identify the manufacturer of each batch of devices.Rec..

Australia TGA, Announces Revised Sunscreen Requirements Through 2024 Measures No. 2

In Australia, sunscreen is classified as a primary sunscreen or a secondary sunscreen depending on the SPF index. If it is classified as a medical product according to the performance of sunscreen, it is subject to TGA regulation, and if it is classified as a cosmetic, it is subject to AICIS regulation. Australia's Therapeutic Goods Administration (TGA) has announced updated requirements for sun..

JNM Global/Cosmetic 2024.07.18

Singapore HAS, Announcement of increase in medical device registration fee

Singapore HSA(Health Sciences Authority) applies Review Fee Increase Effective July 1, 2024. With effect from 1 July 2024, a fee increase averaging 5% will be implemented, with a minimum increase of $1 and capped at $200 per fee item. The increased medical device fees are briefly as follows.1.     Medical Device RegistrationProduct registration and evaluation feeClass BClass CClass DClass D with..