• 2025-12-26 03:50:42

The Thai FDA has issued new Clinical Evaluation Report (CER) guidance that fully adopts the IMDRF framework without modification. As a result, IMDRF-compliant CERs can be used for Thai submissions with minimal administrative adjustment, supporting regulatory harmonization and reduced duplication.

• 2025-07-14 01:44:36

The NMPA issued the Catalog of Medical Devices Exempt from Clinical Evaluation (2025), which took effect on May 12, 2025.

• 2024-09-17 05:23:25

This guidance offers instructions on the clinical evaluation of orphan devices under the MDR.

• 2024-05-08 03:00:06

CMDE has issued a new notice, supplementing previous recommendations with updated clinical evaluation paths for specific medical devices, aiming to guide registration applicants effectively in navigating the regulatory process.

• 2024-04-08 08:22:03

This article explores Qualtech's strategy to achieve this feat, including navigating China's complex regulatory framework and leveraging an experienced medical writing team. The outcome is a faster market entry for Qualtech's product, offering a significant advantage in the lucrative Chinese market.

• 2023-09-27 07:45:33

NMPA revised the Catalog of Medical Devices Exempt from Clinical Evaluation (2021) and published the Catalog of Medical Devices Exempt from Clinical Evaluation (2023).

• 2022-08-30 02:59:24

China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 01, 04, 07-10, 19, as well as 21 of the Category of Medical Devices.

• 2022-07-26 11:00:06

China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 02, 03, 05, 06, 16, 18, as well as 20 of the Category of Medical Devices.

• 2022-06-29 02:03:22

China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 11-15, 17, as well as 22 of the Category of Medical Devices.

• 2021-10-27 07:01:31

In order to strengthen the supervision and guidance of the registration for medical device and further improve the quality of registration review, NMPA has published a new guidance document focusing on equivalence demonstration in clinical evaluation report of intravascular catheters.