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China to Implement New Electrical Safety Standards for Medical Devices
Published on: May 16th, 2022
Requirements Apply to New and Renewal Applications of Registered Devices
An updated China-specific electromedical safety standard (BG 9706.1-2020) that was announced back in February of 2020 will come into full effect on May 1, 2023. Significantly, compliance with the requirements will apply to devices already issued an Imported Medical Device Registration Certificate (IMDRC) and on the market in China as well as new and renewal registration applications. As it can take 12 months to generate qualified test certificates and amend and existing IMDRC, manufacturers with electromedical devices that have not tested to the new Standard should start the process right away to maintain uninterrupted market access in China.
China has its own standards system and the regulations state that testing should be performed according to each products’ technical requirements. The product technical requirements will reference all the related Chinese GB (National Standard) and YY (Industrial standards) standards, so all the testing should be performed according to the related Chinese GB and YY standards. It will be very important for manufacturers to identify applicable standards and work with their preferred laboratory to ensure their products’ certification includes China specific testing requirements.
The NMPA only accepts the test reports from test facilities with China Metrology Accreditation (CMA). As far as we know, there no EMC test lab outside of China has yet obtained China Metrology Accreditation and so testing must be done in China.
Steps to Maintain Market Access for Electromedical Devices Already Registered in China
Updating an existing IMDRC in compliance with the new EMC standards can take more than 12 months, so manufacturers with effected products are recommended to start the process in May 2022.
STEP 1: Update the product technical requirements from GB 9706.1-2007 to GB 9706.1-2020.
STEP 2: Import and test the device in China according to the new standard GB 9706.1-2020. Typical testing fees are approximately US$10,000.
STEP 3: The China Agent of the IMDRC submits a registration information change application to NMPA including the qualified test reports. NMPA application processing fees are US$6,400 for risk Class II medical devices and US$7,700 for risk Class III medical devices.
Overview of New Chinese EMC Standards
All electromedical devices with active IMDRC that were tested to the previous standard (GB 9706.1-2007) will need to be re-tested to meet the new Chinese national compulsory standard GB 9706.1-2020. For general reference, GB 9706.1-2020 is similar to IEC 60601-1 3rd edition.
From May 1, 2023 existing IMDRC will be subject to spot check for conformance to GB 9706.1-2020. Those found not in compliance will subject to penalties. Additionally, the IMDRC renewal process will be complicated for devices that did not update their EMC testing, and a new registration application may be required.
Additional Updated Standards Including Sterilization
Manufacturers of non-electromedical equipment should still review the updated local Chinese standards to see if there have been any new applicable standards. For example, new standards for sterilization went into effect in 2020 and since International Medical Device Registration Certificate (IMDRC) are valid for 5 years, many products that were registered under the old standards may have renewal issues if not tested to the new standard’s requirements. Manufacturers should confirm whether their products need to adhere to new standards and start the process at least a year before renewing.
Potential Implications for Renewal Applications
Renewal applications in China must be submitted to the NMPA at least 6 months prior to the expiration date of the IMDRC. The NMPA acceptance office will review the application for 5 working days and if all documents are qualified, they will issue an acceptance letter and the application will be internally transfer to technical review. For applications accepted 6 months prior to the expiration date, NMPA will issue the new certificate before the old one expires to ensure there are no issues at customs. However, if the application is not qualified (i.e. when new compulsory standards are enforced but the applicant’s product file hasn’t been updated and/or doesn’t contain the relevant test report), the NMPA will not issue the acceptance letter and therefore, the manufacturer may have issues importing products if not resolved in time. For applications that do not receive an acceptance letter 6 months prior to the expiration date, NMPA will not commit to issuing a new certificate before the old one expires.
If the old certificate expires before the new certificate is issued by the NMPA, the manufacture will not be able to import the device(s) into China.
Regardless of new standards adherence, it’s very important for manufacturers to submit renewal applications 6 months prior to the expiration date. That way, if there is submission record, manufacturers will still be able to import if the acceptance letter is not received 6 months prior to the expiration date. Conversely, if there is no submission record and the applicant misses the deadline, a new registration will be required. There had been a grace period for this during COVID but it is likely not available anymore.
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.