Bryan Gilburg - China

“Addressing China’s many unique product standards will be the trick to taking advantage of this new guidance.”

Bryan Gilburg

Managing Director

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

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China to Accept Foreign Generated Test Reports

Published on: December 7th, 2021

Foreign Manufacturers Can Avoid Costly In-Country Testing

On October 22, 2021, NMPA issued the Provisions for Self-testing in Medical Device Registration” (google translation) establishing the opportunity for international manufacturers to use foreign test reports in place of in-country testing required for medical device registration in China. This new regulation is in support of State Order No.739 “Regulation on the Supervision and Administration of Medical Devices” which was released on March 18, 2021 and came into effect on June 1, 2021.

This adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.

Manufacturers now have 4 options:

  1. Conduct Local Testing in China,
  2. Enhance their Quality Management System to include internal sufficient self-testing capabilities,
  3. Use their contract manufacturers self-test reports,
  4. Use an accredited lab to conduct the tests.

Using Foreign Accredited Labs for Test Reports

Manufacturers who wish to avoid in-country testing can work with any government accredited laboratory to obtain the necessary documentation needed for the application. At this time, the NMPA has stated that only government accredited laboratories will be accepted but additional guidance may be issued in the future. Asia Actual recommends manufacturers wishing to use foreign test reports work with a reputable accredited laboratory to help reduce the risk of scrutiny during the review process.

Requirements for Manufacturers That Wish to Submit Their Own Test Reports

The regulatory burden for manufacturers seeking to provide their own self-tests is not simple and will require manufacturer make investments in potentially different areas of their business. However, for manufacturers serious about the Chinese market, this new adjustment provides them with an alternative solution to in-country testing for all of their products. Manufacturers who conduct testing in house will need to show that the test procedures, including test controls, have been incorporated into the Quality Management System (QMS), carried out by qualified personnel in an appropriate facility, and records are maintained.

Required Application Documents

Manufacturers wishing to submit self-test reports will need to submit evidence that they meet the NMPA’s requirements.

  1. Self-Test report by the manufacturer or if outsourced, the qualifications of the test lab.
  2. Statement of Qualification declaring the test entity is qualified to conduct these tests. (Not required if an accredited lab is used)
  3. QMS Documentation. (Not required if an accredited lab is used)
  4. Model coverage description explaining the models and configurations tested.
  5. Declaration that the report is authentic.

For manufacturers that incorporate the self-test requirements into their QMS and submit their own self-test reports, on-site tests will also evaluate self-testing requirements in addition to standard QMS processes. This additional requirement could include spot-checking technical staff, test records, test equipment, etc.

Updating Test Reports Before Renewing Licenses

Per Notice on Matters During the Transition Period of Implementation of New Regulations (No.14 of 2021), issued on October 28, 2021, renewal applications will need to show that the product is in compliance with the latest technical GB & YY standards. Previously, this was a loosely implemented requirement but is expected to be more closely reviewed with the new Notice and could cause the renewal application to be denied. Before submitting the renewal application, manufacturers should complete a gap analysis of their product’s test reports related to Chinese standards and work with a qualifying test lab to remedy any additional needs.

Come Grow With Us

Please contact us if you’d like support understanding these new requirements or are interested in registering your product in China. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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