On November 2, 2017, Chinese Food & Drug Administration (CFDA) released a new regulation which requires overseas applicants/manufacturers to include the standardized Chinese translation of company information within their applications.
- The Chinese name of the applicant should be translated in the format of simplified Chinese and in conformity with the national standard of language.
- The Chinese name shall correspond to the original name in the foreign language and shall not add or delete any content. The same enterprise should use the same Chinese enterprise name.
- The Chinese name shall not contain the contents and words which may harm the interests of the country or the public, or which may cause a misunderstanding to the public, and which are prohibited by laws, regulations and provisions.
Effective July 1, 2018, all submissions to CFDA should have the information of Chinese translation of applicant’s name as outlined in the above points. What should be noted above is the reference to “shall not add or delete any content”. Those who have worked in the Asia Pacific region may well have come across similar issues in other Asia economies where there appears to be differences in the translated information provided to the regulator. This can cause substantial delays and headaches to the applicants. You must be very cautious here and ensure that they’ve had the content reviewed prior to submission.
Class I fillings are required to include the Chinese translation of applicant’s name prior to December 31, 2018. Starting January 1, 2019, all labels of medical devices produced/imported/sold in China are required to have the Chinese translation of applicant’s name.
With the deadline fast approaching, international applicants will need to define their formal company name in Chinese for the change registration to CFDA and update all related labelling upon CFDA approval through a change application. As can be expected, there will be many companies needing to fulfil this requirement in the coming months, so be sure to get started and be ahead of the rush!
Our experienced team have extensive experience in managing multi-language applications and can provide assurance as to the applications being made. If you’d like to discuss how we can support your China application, or any other Asia Pacific regulatory support, contact us for a no-obligation conversation with our team.
If you’re currently working through your CFDA applications for either IVD’s or Medical Devices, or are considering the China market for your product, please reach out to us for a free, no obligation discussion on how we may support you.