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China Regulatory and Commercial Updates

Published on: November 04, 2020

China Regulatory and Commercial Updates – November

The NMPA has continued to stay busy this year, releasing numerous guidance documents and updates to their regulatory requirements. Here are some of the most important updates from the last few months.

Using e-Signatures as Part of Registration Application Documents in China (No. 20 of 2020)

On September 29, 2020, the CMDE issued a notice on matters related to the trial implementation of electronic signatures for the registration application materials of imported medical devices. In this Notice, the CMDE elaborated on what circumstances electronic signatures could be used.

For applicants using electronic signatures they should also submit the following documents:

  1. List of registration application documents used electronic signatures.
  2. Proof of the country (region) where the foreign applicant is located, has established a legal and regulatory system for electronic signatures, along with a Chinese translation of the key provisions.
  3. A statement that the electronic signature complies with the relevant laws and regulations of the country (region) where the overseas applicant is located.
  4. The list of legal representatives that were authorized to use electronic signature and their electronic signature styles.
  5. Statement of authenticity.

Expedited Approval for Products Manufactured in China (No. 104 of 2020)

On September 25,2020, NMPA issued “Announcement on matters related to manufacturing of NMPA approved import medical devices in China” to continue encouraging foreign manufacturers to localize their NMPA approved devices’ production in China. NMPA provided an expedited approval pathway for their devices manufactured in China. Some registration documents such as research data; clinical data; risk management report etc. when used for import device’s NMPA registration could be reused for the NMPA registration of device that are manufactured in China, while new product testing is required.

Updated List of Class III (High Risk) Medical Devices that Require Approval Prior to Starting a Clinical Trial in China (Revision 2020)

On September 18, 2020, the NMPA issued the 2020 revised edition of Class III, high-risk medical devices that need clinical trial approval from NMPA before starting clinical trial in China. Six kinds of medical devices are in the list and they are: implantable cardiac rhythm management devices; implantable ventricular assist systems; 1) implantable drug infusion device, 2) artificial heart valves, 3) endovascular stents, 4) tissue engineering medical products containing living cells and absorbable limbs, 5) long bone internal fixation, and 6) implantable device.

Recently Released Guidelines and Draft Guidelines for Comment

In September 2020, 6 guidelines and 2 draft guidelines for comments were announced, including the following:

  1. “Guiding Principles for Registration of Balloon Dilatation Catheters;”
  2. “Guidelines for Technical Review of Requirements and Evaluation of Infusion Products Needle Stick Protection Devices”;
  3. “Guiding Principles for the Evaluation of Fatigue Performance of Biological Femoral Stems”;

4.”Guidelines for Verification of Virus Inactivation Processes for Allogeneic Implantable Medical Devices (Revised Edition in 2020)”;

5. “Guidelines for Registration and Review of 3D Printing Patient Matching Mandibular Prostheses”;

6. “Guiding Principles for Medical-Industrial Interaction Quality Control Review of Personalized Matching Bone Implants and Tools”;

7. Draft for Comments: “Technical Review Guidelines for Clinical Evaluation of Ultrasonic Soft Tissue Cutting Hemostasis System”;

8. Draft for Comments: “Guidelines for Medical Device Cybersecurity Technical Review Guidelines (Second Edition)”.

UDI Implementation Delayed

In July 2019, the NMPA began piloting their UDI system for medical device. Unfortunately, due to the COVID-19, the official implementation date of the first batch of products has been adjusted from October 1, 2020 to January 1, 2021. Concurrently, NMPA added 5 more products to the first batch of the products subject to UDI implementation. The 5 newly added products are 1) ear prostheses, 2) spinal interbody fixation/replacement systems, 3) absorbable surgical hemostatic materials, 4) penile prostheses, 5) implantable drug infusion devices.

NMPA Published the Summary of the Second Batch of Product Classification Results of 2020

Products with unclear classifications will need to consult with the NMPA prior to submitting their applications. Each year, the NMPA will publish the results of these consultations and recently released the second batch for 2020 (first was published on March 30th).

In this round, there were 321 medical device classification results, 60 products were classified as Class III medical devices, 94 products were classified as Class II, and 49 products were classified as Class I medical devices. The rest were considered combo products, special situations, weren’t standalone medical devices, or not a medical device.

NMPA Issued 34 Medical Device Industrial Standards

On September 27, 2020, NMPA issued 34 Medical Device Industrial Standards which will be implemented after 2021, the 34 medical device industrial standards cover Surgical Implants, Medical Electrical Equipment, Disposables, Software, Imaging Equipment, In-Vitro Diagnostic Reagents etc. Please contact us if you would like a full list.

Contact Asia Actual today for regulatory and commercial support in China.

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