• 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.

• 2021-06-24 02:55:03

We are happy to announce that Qualtech offers extensive services for Clinical Evaluation Report (CER) writing! Shall a CER be of interest for your business, please refer to the information within. Feel free to contact us for a first consulting session on this matter!

• 2021-01-19 02:38:54

NMPA's newly released Guiding Principles explain the general, principled and forward-looking requirements for the application of real-world data of medical devices in clinical evaluation.

• 2020-02-21 06:51:47

On September 17th, IMDRF, the International Medical Device Regulators Forum, has passed the proposal of Medical Device Clinical Evaluation, with unanimous approval of the IMDRF members. This proposal is written by Medical Device Clinical Evaluation Working Group, which is led by China NMPA.

• 2020-05-06 09:07:05

In the recent years, CMDE has started to adjust the internal workflow to optimize the registration process. In 2015, they have changed the structure of the reviewing department. This time, they have set up two different departments for a faster operation.