Regulatory updates Archives

Philippines: Food and Drug Administration released the draft Schedule of Fees and Charges for Licensing, Registration and Other Authorizations and Regulatory Services

November 1, 2023

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

Singapore: New Revision of the Medical Devices Product Classification Guide

November 1, 2023

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

Thailand: Updates on Renewal of Certificates for Manufacturers and Importers in Thailand

October 11, 2023

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

Certification Cost of Device Certification

Indonesia: Cost of Device Certification according to Government Regulation No. 43 Year 2023

October 10, 2023

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: Updated Government Fee for the Evaluation Process of Registration Application in Vietnam

October 9, 2023

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

Vietnam: New Draft Guidelines for Declaring Prices and Safety Inspection Procedures and Technical Features for Medical Devices in Vietnam

October 9, 2023

The Vietnam Ministry of Health is currently drafting a Circular to issue a list and provide guidelines for declaring the prices of medical devices. Simultaneously, the Ministry of Health has sent a letter requesting input from various organizations on the draft Circular regarding the list and guidelines for declaring prices

Regulatory Updates

Regulatory Updates

Philippines: Food and Drug Administration released the draft Schedule of Fees and Charges for Licensing, Registration and Other Authorizations and Regulatory Services

Singapore: New Revision of the Medical Devices Product Classification Guide

Thailand: Updates on Renewal of Certificates for Manufacturers and Importers in Thailand

Indonesia: Cost of Device Certification according to Government Regulation No. 43 Year 2023

Vietnam: Updated Government Fee for the Evaluation Process of Registration Application in Vietnam

Vietnam: New Draft Guidelines for Declaring Prices and Safety Inspection Procedures and Technical Features for Medical Devices in Vietnam

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Regulatory Updates

Regulatory Updates

Philippines: Food and Drug Administration released the draft Schedule of Fees and Charges for Licensing, Registration and Other Authorizations and Regulatory Services

Singapore: New Revision of the Medical Devices Product Classification Guide

Thailand: Updates on Renewal of Certificates for Manufacturers and Importers in Thailand

Indonesia: Cost of Device Certification according to Government Regulation No. 43 Year 2023

Vietnam: Updated Government Fee for the Evaluation Process of Registration Application in Vietnam

Vietnam: New Draft Guidelines for Declaring Prices and Safety Inspection Procedures and Technical Features for Medical Devices in Vietnam

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

Main Pages

Address

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Phone Number

Main Pages

Address

E-mail Address

Phone Number

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