Regulatory updates Archives

Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia

December 14, 2023

On 5 December 2023, the Ministry of Health (MoH) of Indonesia released an announcement letter No: FR.03.01/E.V/2510/2023 regarding the maintenance process of the MoH platform for online licensing system of medical devices and household supplies registration, issuance of online certificates, and issuance of medical devices distribution license (IDAK). Therefore, the

Indonesia: Procedure for the Implementation of Foreign Halal Certificate Registration by The Halal Product Guarantee Administering Agency (BPJPH) in Indonesia

December 14, 2023

Based on Law No. 33 of 2014 regarding Halal Product Guarantee, all foreign halal products imported into Indonesia do not require to apply for a local halal certificate, if the foreign halal certificate is issued by a foreign halal institution that has collaborated on mutual recognition of halal certificates with

Indonesia: Draft of Government Regulations concerning the Implementation of Law No. 17 of 2023 concerning Health in Indonesia

December 14, 2023

A draft of Government Regulations pertaining to the Implementation of Law No. 17 of 2023 concerning Health was uploaded on the Ministry of Health of Indonesia official website. This regulation was derived from Law No. 17 of 2023, in which one of the clauses mentioned that the further implementation of

People working together on application at laptop

Philippines: PFDA Issued a Draft Guidance Documents on CMDN Initial Application via FDA eServices Portal System

December 14, 2023

PFDA issued a circular draft for comments regarding the guidelines on the use of the eServices portal system for the initial application of Certificate of Medical Device Notification (CMDN) in line with the PFDA’s goal of delivering efficient government services. Currently, CMDN applications are transacted via the ePortal System. Migrating

Singapore: HSA Shares Revisions on Change Notification Guidelines Following EU MDR and IVDR Changes

December 13, 2023

On November 20, 2023, the Health Sciences Authority (HSA) Singapore revised the guidance document on Change Notification applications due to EU MDR and IVDR-related changes to registered medical devices. The identified changes clarified in this update are the following: Changes to IFU related to clarification of existing content and addition

Vietnam: Ministry of Health Releases Circular to Repeal Existing Regulations

December 12, 2023

On 14 November 2023, the Vietnam Ministry of Health released Circular 20/2023/TT-BYT repealing some legal regulations issued by the Ministry of Health. By January 1, 2024, the following regulations will be completely revoked: Regulation Regulation Date Provision Directive No. 06/2008/CT-BYT June 27, 2008 The enhancement of the quality of healthcare

Regulatory Updates

Indonesia: Temporary Closing of the Online System for Submission of Medical Devices and Household Supplies Registration, Online Certificates, and Distribution License by the Ministry of Health of Indonesia

Indonesia: Procedure for the Implementation of Foreign Halal Certificate Registration by The Halal Product Guarantee Administering Agency (BPJPH) in Indonesia

Indonesia: Draft of Government Regulations concerning the Implementation of Law No. 17 of 2023 concerning Health in Indonesia

Philippines: PFDA Issued a Draft Guidance Documents on CMDN Initial Application via FDA eServices Portal System

Singapore: HSA Shares Revisions on Change Notification Guidelines Following EU MDR and IVDR Changes

Vietnam: Ministry of Health Releases Circular to Repeal Existing Regulations

Countries

Categories

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

Main Pages

Address

E-mail Address

Phone Number

Main Pages

Address

E-mail Address

Phone Number

Stay Ahead in Southeast Asia's Medical Device Market!