China NMPA Newsletter – October 2022

Featured Articles

NMPA New Approvals In October 2022

In October 2022, NMPA approved 204 medical devices, including 34 Class III imported products, 23 Class II imported products, and 146 Class III domestic products.

Below is a list of approved Class III and Class II imported products in October, 2022.

Sources: NMPA

Last Call For Testing & Modification Registration Of The GB 9706.1-2020 Standard Upgrade!

If your active medical device was approved by the China NMPA before 2021, most likely, you are not compliant with the newly upgraded Chinese national standard GB 9706.1-2020. 

Standard Upgrade 

The newly revised GB 9706.1-2020 Chinese standard will replace the GB 9706.1-2007 version. The newly upgraded GB 9706.1 standard is synchronized with the international standards IEC 60601-1:2012 (edition 3.1).  

Implementation Date 

At present, all seven parallel standards supporting GB9706.1-2020 have been released, and special standards are being released in batches. Regarding the implementation date of GB 9706.1-2020 and the supporting parallel standards, there are two key time points: 

• If the product does not involve special standards, the implementation date of GB 9706.1-2020 and the supporting parallel standards will be May 1, 2023. 
• If the product involves special standards, the implementation date of GB 9706.1-2020 will follow the implementation date of the special standards.  

Cited from “GB 9706.1-2020 and its supporting juxtaposition and special standard implementation rules (draft for comments)” 

For example, YY 9706.252-2021 standard (Medical electrical equipment — Part 2-52: Requirements for the basic safety and essential performance of medical beds) will be implemented on May 1, 2024, the implementation date of GB 9706.1-2020 for medical beds will be synchronized to May 1, 2024.  

Major Changes 

Compared with GB 9706.1-2007, the biggest change in the new version of the standard is the introduction of the concept of risk management, and the evaluation of basic performance is required. It is not enough to consider only basic safety, but also the basic performance of the product. A detailed comparison between the 2007 and 2020 version is available on request at info@bradyknowsmedical.com  

Modification Registration 

For medical device manufacturers who have products approved in China, you need to implement the standard upgrade by its implementation date. You need to complete China local testing, obtain test reports and submit a modification registration to the NMPA for approval. If you fail to complete the modification registration before the deadline, you will not be able to continue your sales in China and your future renewal registration will be jeopardized.  

Considering the large difference between the 2020 version and 2007 version of the standard and the limited testing resources in China, to smoothly transition to the new version of the standard, it is recommended that you plan early and do adequate preparations.  

If you have not started the testing and modification registration process for the GB 9706.1-2020 standard upgrade, call BradyKnows for help.  

Initial Registration 

For manufacturers who have ongoing product initial registration in China, please check if your type testing is following the GB 9706.1-2020 version standard. If not, you may need to start a GB 9706.1-2020 testing in parallel to your existing registration to make sure that your newly approved product will be compliant with the upgraded standards. 

NMPA Notice on Adjustment of Technical Consultation about Medical Devices Registration before Application Acceptance

In order to comprehensively promote the development of China’s medical device industry and give full play to the technical support role of the medical device innovation service station for the development of medical device industry in the region, NMPA issued Notice on Adjustment of Technical Consultation about Medical Devices Registration before Application Acceptance (NMPA, No. 37, 2022) on October 16, 2022.

CMDE as the lead unit, responsible for the overall management and organization of the implementation of technical issues consulting work before registration acceptance. Drawing on the experience of the Yangtze River Delta Sub-Center for Devices and the Great Bay Sub-Center for Devices to carry out pre-registration technical issues consultation work, medical device innovation service stations in Sichuan Province, Jilin Province and Fujian Province, Beijing Municipal Medical Products Administration and Hainan Medical Products Administration are as a participating unit into the scope of pre-registration acceptance of technical issues consulting work.

The notice mainly describes the technical issues consultation before the acceptance of medical device registration, including on-site consultation time, on-site consultation location, consultation object and scope, consultation arrangements, consultation form, notes and contact information.

If you have any questions about Notice on Adjustment of Technical Consultation about Medical Devices Registration before Application Acceptance, please contact info@bradyknowsmedical.com.

The Third Batch of Medical Device Product Classification Identification in 2022

Center for Medical Device Standardization Administration, a branch of NMPA, issued a summary of the third batch of medical device product classification identification on October 27, 2022.

A total of 388 medical device product classification results have been summarized from July to September 2022, of which 45 products were suggested to be regulated as Class III medical devices, 149 products were suggested to be regulated as Class II medical devices, 98 products were suggested to be regulated as Class I medical devices, 75 products were suggested not to be regulated as medical devices, 4 products were suggested to be regulated as drug-device combination products, 2 products were suggested to be managed on the specific situation, and 15 products were suggested not to be regulated as medical devices alone.

If your products are not listed in the Medical Device Catalogue of NMPA, the application of category classification to NMPA is a good solution to identify the class of your device. We do highly recommend to map out your strategy to enter China before you kicks off the registration, including digging out the category of your device in China. Sometime, if your product is Class II in US, but it may be regulated as Class III in China.

BradyKnows elite team is very knowledgeable about the classification of medical device products, if you have any questions about this, please contact info@bradyknowsmedical.com.

New China CER Website

The new website was built based on the newly updated clinical evaluation requirements and regulation in China under the Order 739.

We are here to help you obtain China market approval for your medical devices with a comprehensive Clinical Evaluation Report (CER). Before jumping to any conclusions, use our newly developed tool for a CER FEASIBILITY SELF-EVALUATION

Resources – Webinar

Please click here to review the record of BradyKnows webinar.

• Keep Up With The Trend Of Medical Devices Localization In China: Background, Policy, Regulation, And Case Study
• Introduction Of Medical Device Registration Process In China
• Medical Device Real World Evidence (RWE) In China: Policies, Usage, Study Plan, Case Study
• China Regulatory Updates Of Q1/2022 & Tips For Medical Device Registration Under Covid
• How To Increase The Likelihood Of China CER Approval?
• Keep Up With The Enhancement Of Medical Device Post-Market Surveillance In China: GMP, GSP, And NMPA Onsite Inspections

Resources – Documents Download

• Announcement On Issuing The Guideline On The Preparation Of Annual Self-Inspection Report On Medical Device Quality Management System (No. 13, 2022)

Resources – FAQ

• For High-risk Medical Devices Using Polymer Materials, Are Two Or More Raw Material Suppliers Allowed For The Raw Materials Of Product Parts?
• Why Is It Necessary To Verify The Purity Of Metal Powder For Additive Manufacturing In Dentistry?
• What Are The Principles For Establishing Acceptance Criteria For Ethylene Oxide Residuals In Products Such As Suture Anchor, Titanium Plate With Loop?
• How Should The Declared Special Properties Of Infusion Products Be Verified?
• What Contents Should Be Included At Least In The Device Characteristic Description On The Product Structure And Design Of Dental Implant?
• What Should Be Focus Of The Performance Studies Of PMMA Bone Cement Products At Least?
• As For Implantable Medical Devices Which Are Degradable And Absorbable, Can Published Literature By Research Institutions Related To The Products Made Of The Same Material Or The Raw Material Of The Product Under Application Be Used As The Performance Research Data On Product Degradation?
• Which Surface Performance Studies Should Be Conducted For The Dental Implant With Sandblasted And Acid-etched Surface At Least?
• What Are The Interests In The Review Of Metallic Powder Materials For Additive Manufacturing In Dentistry?
• Can The Extraction Limit Of Soft Corneal Contact Lenses Determined Based On The Extraction Study Report Of The Same Kind Or Similar Products Be Submitted?
• How To Evaluate The Safety Of DEHP In Single Use Hemodialysis Tubing Made Of PVC Raw Materials Plasticized By DEHP?
• Should The Mode Of Connection Between Dental Implant And Abutment Fall Under Product Structure And Components?
• Should Manufacturer Take The Oxygen Permeation Properties Into Consideration When Changing The Center Thickness Of Soft Contact Lenses?
• What Aspects Should Be Considerded In Registration Submission When Multiple Receiving Coils In MRI System Are Used Jointly?
• When Applying For Registration Of PET/CT Products, If The CT Has Obtained The Registration Certificate, How To Provide The CT Related Overview Material And Research Data?