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China Regulation Updates from the month of September

1. Cyber security technical file guideline edition 2 is released for comments.

 

NMPA published 2nd edition of cybersecurity guidelines (asking for comments now) to regulate the technical file composing for this subject more reasonably.  Comparing to the current 1st edition, the new draft version expands the content length from 18 pages to 38 pages.  The user access is added to include human-computer interaction based on software-user interface (including standalone software and software components) and electronic interface (including network interface and electronic data exchange interface).  It also clarifies the personal data type as sensitive and non-sensitive data, which may require different level of data protection.  Setting up Emergency Response Mechanism to network security incidents.  The software version naming rule should cover the network security update. Emphasize the management for the product whole life cycle and incorporate with software as medical device management. Export of data - It is not allowed to store private health information in overseas servers, and the export of data need to perform safety assessment. Remote maintenance function shall address the unattended times and provide method to justify the attendance methods.  Obsolete equipment- For the medical devices whose registration certificate is invalid but has not stopped the after-sales service, and the registration certificate is valid but has been stopped for sale, the registrant shall provide the existing users with necessary network security related information and countermeasures according to the requirements of quality management system, so as to ensure the network security of medical devices. Cybersecurity may not be required included as part of PTR but clarified in research document and IFU. Renewal technical file do not require cybersecurity technical file.  

 

2. List of class III medical devices subject to clinical trial pre-approval (2020 edition) is released. 

The 2014 edition is abolished immediately.  Medical devices with new design, new material or mechanism, and / or new intended scope and high risk to human body should gain approval before the clinical trial can be carried out in China.  The device categories include Implantable heart rhythm management equipment including pacemaker, implantable ventricular assist system, implantable drug infusion equipment, artificial heart valve and vascular stent, tissue engineering medical products containing living cells and absorbable bones. Comparing with the older edition, the new edition adds on category of artificial heart valves, and tissue engineering medical products containing living cells. Orthopaedic implants containing nano material and 3D orthopaedic implant are removed from the pre-approval list.

3. Announcement of transferring production of imported medical devices in Chinese Enterprises (Order 140, 2020) is released by NMPA.

The foreign-invested enterprise established by the registrant of imported medical devices approved in China may apply and submit the application for domestic medical devices licenses as well. This policy is applicable to imported class II and class III devices. Majority of the domestic license application technical files are sharing the same files used for import registration, such as summary document, research data, clinical evaluation report, and risk analysis files. The applicant shall guarantee the main raw materials and production processes will not change, and provide the self- inspection report of the quality management system of domestic production against the China GMP, and the comparison report of quality management systems at home and abroad.

4. An extension of the implementation of the 1st trial product group of UDI.

In order to fully verify the implementation of the unique identification system, NMPA extend the pilot period of the 1st batch of unique identification system product from 31th October to December 31, 2020.  During the pilot period, enterprises can upload, maintain and update data to the UDI database of medical devices. All relevant parties can share the data through the unique identification database and medical institutions are encouraged to actively explore the connection and application of UDI with device management, clinical application, medical insurance settlement and other related areas.  When pilot period finish, short-listed products out of the trial scope will be officially implemented since 1st January 2021. 5 categories of high-risk class III medical devices, including ear prosthesis, spinal vertebral fixation / replacement system, absorbable surgical haemostatic materials, penile prosthesis, and implantable drug infusion equipment, are the required devices.

Should you have more questions regarding China regulations, please feel free to contact Qserve at info@qservegroup.com.

Stephanie (Xing) Huang
Post date: October 20, 2020
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