Bryan Gilburg - China

“Learn how the updated regulatory and commercial policies in China can affect your medical device sales”.

Bryan Gilburg, Asia Actual

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

Sources and Links

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.

Blog Posts

Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices

Per Presidential Regulation 12/2021, the Ministry of Health (MOH) is requiring products with a Domestic Component Level (TKDN) and Benefit Weigh Value (BMP) of 40% or more be purchased by government hospitals regardless of available foreign products.

Philippines Announces New PEMDL Essential Medical Device List

Notification AO 2021-0038 was released on June 11th, 2021 with the goal of creating a standardized system for determining and maintaining a database of essential medical devices, hereby known as the Philippine Essential Medical Device List (PEMDL). Additionally, the Medical Devices and Supplies Price Reference Index (MDSPRI) will also be established to provide more price transparency when it comes to medical devices in the Philippines.

Russia and Euro-Asian Neighbors Expected to Transition to EAEU Regulations in 2022

With the release of Decree 142, the Russian government has provided a roadmap for their transition to the new EAEU medical device regulations beginning January 1, 2022. After this date, all applications submitted must adhere to the EAEU rules which can vary significantly from the current Russian requirements.