New Process for the Registration Application of Class C and D Medical Devices in Vietnam The Vietnam Ministry of Health posted on the DMEC website on the 10th of October 2023 regarding the new reception and registration process of Class C & D medical devices. Accordingly, the pre-assessment process for
The Philippines Food and Drug Administration held a virtual public consultation on the draft Administrative Order entitled “Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services”, October 27th 2023. The aim of the proposed draft
On October 2nd, 2023, the Health Sciences Authority of Singapore (HSA) issued a second revision of GL-06: Medical Device Product Classification Guide. This guidance document is applicable to all medical device dealers namely registrants, manufacturers, importers, and distributors. The main highlights of the updated guidance document include the following: To
The Thailand Food and Drug Administration (TFDA) made an announcement to notify importers and manufacturers in Thailand that the renewal system will be opened starting October 1st, 2023, to December 31st, 2023, for the following certificates: Establishment Registration Certificate Sales License License/ Notification Certificate (applicable for approved products based on
On 19 September 2023, Indonesia’s Ministry of State Secretariat released the Government Regulation No. 43 Year 2023: Types and Rates of Non-Tax State Revenues that Apply to the Ministry of Communications and Information Technology, which revokes Government Regulation No 80 Year 2015. This new regulation will be implemented within 60
Vietnam Ministry of Finance released Circular 59/2023/TT-BTC on 30 Aug 2023 pertaining to regulation on the collections, payment, management, and use of fees in the healthcare field. According to this regulation, the Government fee for the evaluation process of registration applications effective 16 Oct 2023 would be as follows: Class
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