• 2020-04-14 08:57:04

NMPA has revised the quality inspection measure of medical devices to show their determination on strengthening post-market surveillance. The worst-case scenario manufacturers may face in PMS would be total product recall.

• 2020-04-14 08:54:35

Guiding manufacturers to develop medical devices which are safe and high performing, NMPA has released basic principles of investigation for all class of medical devices.

• 2020-04-14 08:47:59

In order to promote high-quality medical device industry, China is looking for ways to encourage domestic manufacturers to adopt higher technology and introduce incentives for foreign manufacturers with investments by local establishments.

• 2020-02-21 07:28:02

Due to the novel coronavirus pneumonia epidemic and its impact on China, the NMPA, local testing center and clinical sites have been given priority to emergency medical device approvals in epidemic situations. As a result, the progress of ordinary cases may be delayed

• 2020-02-21 07:23:38

Qualtech assisted in all registration stages, which included our service of planning the product pre-market strategy, conducting type testing, clinical trials, GCP inspection, medical writing, and the registration itself.

• 2020-02-21 07:12:37

On December 20, 2019, the NMPA issued an update of the Exemption List from Clinical Trials in China for Medical Device (hereinafter simply referred to as the “Exemption list"), which includes "medical devices" and "in vitro diagnostic devices".

• 2020-02-21 07:11:54

After publishing the guidance of clinical evaluation in the International Medical Device Regulators Forum (IMDRF), the NMPA has quickly released the revised guidance of clinical evaluation for China registration. This guidance is predicted to be implemented by 2021.

• 2020-02-21 07:11:04

On December 20, 2019, the NMPA has issued the so-called "Guidelines for Conditional Approval of Medical Devices " . The Guideline was officially implemented on the day of release and will help expedite the conditional approval of medical devices under certain circumstances.

• 2020-02-21 07:10:23

On December 25, 2019, the NMPA issued the so-called "Guideline for General Naming Rules for Medical Devices" (hereafter simply referred to as the “Guideline”), which is based on the "Medical Device Common Name Naming Rules". The Guideline is formally implemented from now on, and is applicable to medical devices only, not including IVDs.

• 2020-02-21 06:53:42

It is honor for Qualtech to receive an invitation from Hujing College, USST for the program ‘Training and Exchange of Precision Medical Innovation Technologies under the Background of Comprehensive Health’ in Shanghai, China from 25th November to 8th, December 2019. Diversity group of trainees consisted of innovators and professors from Brazil, South Africa, Israel, and Singapore, where Qualtech ASEAN represents Malaysia and Thailand.