• 2026-02-25 04:43:48

Thai FDA has provided recommendations on applicable international standards for particular types of active medical devices to support medical device registration in Thailand. These standards are presented as advisory references only and are intended to assist the registrants in preparing relevant test reports in accordance with the ASEAN Common Submission Template Dossier (CSDT).

• 2021-06-25 12:28:19

As previously notified, the CDSCO has expanded the list of regulated medical devices in India, ranging from CT scan equipment, MRI equipment, defibrillators and more, in addition to all types of implantable devices

• 2020-06-11 09:48:40

NMPA publishes a clear guidance to regulate the raw material change in medical device. In this guidance, it points out three major changes on material component and how to perform the risk assessment on raw material change.

• 2020-05-06 08:22:59

The NMPA has issued the first global regulatory on the lifetime of active medical devices. This guideline provides various aspects on lifetime evaluation, and all manufacturers producing active medical device should carefully regards this specific issue.

• 2020-02-12 14:08:37

Medical device regulations in China have changed frequently in the recent years. With its 10-year experience in the registration of non-active medical device in China, Qualtech would like to share an overview of the common roadblocks of the registration process a foreign manufacturer frequently encounters.

• 2020-02-14 04:00:29

In order to enhance the requirements for clinical trial approval for non-active implantable medical devices, CNDA has issued “the Guidelines for the Submission Documents of Clinical Trial Application for Non-active Implantable Medical Devices” (hereinafter referred to as the Guideline) in June.

• 2020-02-14 07:34:46

Medical device regulations in China have changed frequently in the recent years, such as updating of multiple national standard andindustry standards, issuing of product guidance and administrative directives. With its 10-year experience in China's active medical device registration,