Regulatory Updates

Regulatory Affairs Update: Indonesia

Indonesia: Minister of Health Issued a New Regulation Pertaining to Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices

August 21, 2024

The Minister of Health of Indonesia has established regulation Number 3 of 2024 about Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as The Inclusion of Information on The Origin of Materials for Medical Devices on 5th March 2024 and stipulated on 2nd April

Regulatory Affairs Update: Philippines

Philippines: PFDA Shares the Guidelines for the Pilot Implementation of the FDA eServices Portal System for the Initial Application of CMDN within the National Capital Region (NCR)

August 14, 2024

On August 2, 2024, the Food and Drug Administration (FDA) released an advisory regarding the implementation guidelines for a platform for submitting CMDN applications. FDA is currently developing the FDA eService’s Portal System – an online platform for a streamlined initial application of a Certificate of Medical Device Notification (CMDN).

Regulatory Affairs Update: Vietnam

Vietnam: MoH Shares New Draft Law on Medical Devices in Vietnam

August 6, 2024

From a conference attended by Andaman Vietnam team on July 11, 2024, the Ministry of Health announced that they are preparing to submit to the Government a draft Law on Medical Devices by December 2024. Currently, medical devices in Vietnam are under the management of some valid regulations such as:

Regulatory Affairs Update: Thailand

Thailand: Five Things to Be Aware of Regarding Notification of Advertisement of Medical Devices Direct to Healthcare Professionals That Is Exempt from Authorization

August 6, 2024

Last July 24, 2024, Thailand FDA released an infographic about Advertisement of Medical Devices Direct to Health Professionals. The summary of the information is as follows: Advertising medical devices that are exempt from authorization to healthcare professionals is a form of direct advertising with specific characteristics and methods aimed only

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