• 2024-09-17 05:40:30

NMPA issued a notice that administrative paperwork for some registration matters will become electronic versions starting June 1, 2024.

• 2024-09-17 05:26:27

The National Medical Products Administration (NMPA) and National Health Commission (NHC) have issued guidelines for the temporary importation of urgently needed medical devices in clinical settings. The regulation streamlines import processes while ensuring compliance with safety standards, allowing medical institutions to quickly access essential, unregistered devices. It aligns with NMPA Orders No. 47 and 48, emphasizing patient safety and timely access to critical medical equipment.

• 2024-06-20 06:09:46

This announcement outlines measures to reinforce the supervision and management of commissioned production by medical device registrants, ensuring the full implementation of quality and safety responsibilities and effective risk prevention and control in accordance with regulations.

• 2024-03-01 09:11:58

The NMPA decided to establish a technology-centralized unit for the standardization of medical device packaging.

• 2024-03-01 08:29:27

Starting from 1 January 2024, Hong Kong Medical Device Division (MDD) has accepted on a regular basis marketing approvals from the Ministry of Food and Drug Safety (MFDS) of South Korea and National Medical Products Administration (NMPA) of Mainland China to support the listing application of medical devices in Hong Kong.

• 2024-01-26 07:14:49

The NMPA has revised the Quality Management Standards for Medical Device Operation. This article summarized the critical points of the revision.

• 2024-01-26 07:08:51

A regulation on the management of emergency use of medical devices (trial) is issued.

• 2023-11-20 03:05:02

On October 20, Qualtech hosted a webinar titled "Korea Market Expansion and China NMPA Updates." With over 60 global participants, the event marked Qualtech's entry into the Korean market, sharing actionable steps for successful medical device registration. The second segment covered key changes in China's Medical Device regulations from September 2022 to August, ensuring attendees were informed about the latest regulatory developments.

• 2023-10-20 08:44:59

NMPA adjusted the "Medical Device Classification Catalog", involving 58 Medical Device Classifications. Among the important adjustments are strengthening the management of soft tissue ultrasound heads and breast rotary cutting products.

• 2023-07-21 03:42:44

NMPA issued <The appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Inspection of Quality Management of Enterprises Providing Medical Device Transportation and Storage Service>.