Import medical device registration applicant and record holder name using Chinese
Pharmaceutical Network November 3 hearing in accordance with the "Regulations on the Supervision and Administration of Medical Devices," "Medical Device Registration" "in vitro diagnostic reagents registration and management practices" and "medical device manuals and labeling regulations" and other provisions in our country to apply for medical devices listed , The names of registered applicants, registrants and filers should be in Chinese. For the further implementation of the relevant requirements, to better meet the needs of the public and to receive social supervision, the names of applicants, registrants and record holders of imported medical device registrations are now in Chinese The following is a notice of the relevant issues (the following will be imported medical device registration applicants, registrants and filing agents referred to as the enterprise):
First, the principle of Chinese use
(1) The name of a Chinese enterprise shall be translated by the enterprise itself. It shall use simplified Chinese characters and comply with the national language specification.
(2) The name of the Chinese enterprise shall correspond to the original name, and no content shall be added or deleted. The same enterprise shall use the same Chinese enterprise name.
(3) The name of a Chinese enterprise may not contain content and words prohibited by the laws, regulations and rules that may detriment or misunderstand the public if it undermines the state or public interests.
If the original name does not change, the Chinese name may not be changed in principle. If it is necessary to change the Chinese name in accordance with the law, the registration information may be changed or changed.
Second, procedures and data requirements
Registered or filing imported medical device registrants or filing agents, you can register for change or change the record information to increase the Chinese business name.
The declaration shall include the statement that the name of the Chinese enterprise conforms to the requirements of this announcement and the corresponding responsibility of the enterprise when handling the matter; the name of the Chinese enterprise in the declaration shall be consistent with the Chinese written in the application form and the filing form The signature requirements and other declarations consistent.
For the same business name of the case, such as corporate name on the Chinese business content of the statement is also the same, can only provide a statement of the original. Other declarations can provide a copy of the statement from proxy People indicate the origin of the original and promised a copy of the same with the original; a copy of the statement should be signed by the agent, without the business signature.
Third, for scheduling
(A) from the date of this announcement, has been registered or filing of imports medical instruments Registered person or the record holder, you can change the registration matters or change the record information, add Chinese enterprise name.
(2) Starting from July 1, 2018, when an enterprise applies for registration, renewal of registration, alteration of permitted items or filing, it shall fill in the corresponding fields of the application form and filing form with the name of the Chinese enterprise.
(3) Where a medical device of the first type that has been filed has not been registered and the name of a Chinese enterprise has not been registered, the enterprise shall, before December 31, 2018, alter the record keeping information and add the name of the Chinese enterprise.
Starting January 1, 2019, all the imported type I medical devices, manuals and labels in Chinese medical devices produced after January 1, 2019 shall include Chinese and shall be in conformity with the Chinese corresponding to the record filing information or the changed record filing information .
(4) Where a registered second-class and third-class medical device is imported, in the case of the same business name, the enterprise shall, at least by December 31, 2018, handle at least one medical device registration certificate or registration change containing the name of the Chinese-language enterprise Documents; other valid medical device registration certificate may not be separately for the increase of Chinese enterprises to change the registration of registration matters, to apply for renewal of registration or other registration changes together.Enterprises can be handled in accordance with the documents published in the Chinese business name printed Other medical equipment manuals and labels.
Starting from January 1, 2019, all the importation of Class II and Type III medical device manuals and labels in the enterprise after January 1, 2019 should include Chinese and Chinese should be associated with the product (or other Product) registration certificate (or registration change document) corresponds to the same Chinese.
Fourth, other matters
Where a dispute arises in the name of a Chinese enterprise, it shall be in accordance with the relevant laws, Regulations The provisions of the deal.
