Philippines FDA to Expedite Applications Approved Under AMDD-CSDT

Products approved under AMDD harmonized regulation with CSDT documentation are now eligible for an expedited review by the Philippines FDA.

China to Implement New Electrical Safety Standards for Medical Devices

An updated China-specific electromedical safety standard (BG 9706.1-2020) that was announced back in February of 2020 will come into full effect on May 1, 2023.

India’s CDSCO Expected to Begin Enforcing Local BIS Standards

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.

New Advertising Exemption in Thailand

A Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.

Indian Industry Association Drafting a Uniform Code for Medical Device Marketing Practices

The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.

India’s CDSCO Updates Classification of Several Product Categories

The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017.

India Launches Scheme for Promotion of Medical Device Parks

The scheme for “Promotion of Medical Device Parks” is a key initiative to support the medical devices industry with with a financial outlay of Rs. 400 crore (~US$51 million).

India Establishes Committees to Streamline Regulatory Framework and Address Denovo Products

The Indian government has established 2 committees to help streamline the regulatory framework and establish denovo guidance.

Taiwan FDA Launches New ePortal for Medical Device Applications

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

TFDA Implements New Annual Reporting Requirements in Thailand

On June 1, 2022, the Thai FDA released Gazette 138, Section 118 requiring license holders submit annual reports by March 30th of every year.