Tag Archive for: advertising

Thailand FDA to Improve Medical Device Advertising Review Times

In a training seminar held on January 15 and 16, 2024, by the Thai FDA on the Full Common Submission Dossier Template (CSDT), the TFDA stated their intention to improve the advertising approval process. Per the Deputy Secretary General, they plan to implement new processes meant to help expedite the approvals of advertisement applications.

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

China to Regulate Medical Device Advertising

China is developing new standards and processes for the regulation of advertising for medical devices (as well as pharmaceuticals, food supplements and cosmetics). The goal is to maintain the order of the advertising market, standardize the review of advertisements and protect the rights and interests of consumers.

Medical Device Advertising Requirements in Asia

In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

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.