The China Food and Drug Administration (CFDA) is reportedly considering a new regulation that will require foreign medical device manufacturers to supply information about their company in Chinese as part of their registration submission.
According to a recent posting by the Emergo Group, the proposed regulation would require applicants to translate their company names and addresses into “simplified Chinese,” ensuring that their translations are consistent with their English-language names. If adopted, the proposed Chinese language requirements would take effect as of January 1, 2018 for all new foreign applications for medical devices.
Under the proposed regulation, manufacturers with existing medical device registrations will be required to submit change notifications that add their company name and address information in Chinese by the end of 2018. In addition, devices manufactured after January 1, 2019 will be required to provide Indications for Use and product labels that include manufacturer information translated into Chinese.
Read the original Chinese text of the proposed CFDA regulation.
Read the Emergo Group summary of the proposed change.
