A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

Indonesia to Permit Some Class A Products to Register via Notification

On January 10, 2022, Indonesia’s Ministry of Health released Indonesia Class A Notification Announcement 01.05500242022 establishing a new registration route for some low risk medical devices effective immediately.

Vietnam’s MOH Holds Conference on Price Declaration

The conference was held to provide clarity to the Price Declaration process and announce the establishment of a new online portal for license holders to declare prices. This comes as many provincial health services, including Ninh Binh and Dak Nong, have not been able to purchase medical products since January 1, 2022.

Thai FDA Fast Track Route for COVID Related Products to Stop

The TFDA has announced that the Fast Track registration route for COVID related products will be discontinued from November 4th, 2022 onwards.

Taiwan FDA Medical Device Advertising Requirements

The Taiwan FDA has implemented the premarket E-Submission Portal aimed at making it easier for manufacturers to submit their applications

Thai FDA Implements Initial Screening Step to Submission Process

Beginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.

India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries

On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

India’s MOH Releases Draft Amendment to the Medical Device Rules 2017

On 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.

Taiwan’s New TCP III in Effect as of January 1, 2022

The Taiwan FDA implemented the third generation of the Taiwan-Europe Technical Cooperation Program (TCP III) on January 1, 2022.

India’s CDSCO Temporarily Delays Implementation of UDI Requirements

UDI requirements in India were supposed to begin January 1, 2022 but have been delayed temporarily and expected to be based on IMDRF guidance.

India Issues New Sales License Requirement for Medical Devices

On September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.