Philippines FDA to Expedite Applications Approved Under AMDD-CSDT

/in , /by

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

Read more

China to Implement New Electrical Safety Standards for Medical Devices

/in , /by

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.

Read more

India’s CDSCO Expected to Begin Enforcing Local BIS Standards

/in , /by

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.

Read more

New Advertising Exemption in Thailand

/in , /by

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.

Read more

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

/in , /by

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.

Read more

India’s CDSCO Updates Classification of Several Product Categories

/in , /by

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.

Read more

India Launches Scheme for Promotion of Medical Device Parks

/in , /by

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).

Read more

India Establishes Committees to Streamline Regulatory Framework and Address Denovo Products

/in , /by

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

Read more

Taiwan FDA Launches New ePortal for Medical Device Applications

/in , /by

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

Read more

TFDA Implements New Annual Reporting Requirements in Thailand

/in , /by

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

Read more