I, the first class of medical devices for the record
(a) medical devices for the record refers to the food and drug supervision and management department of the medical device filing (hereinafter referred to as the filing of the filing of information submitted to the record of the first class of medical devices archived for inspection.
(b) the implementation of the record of medical devices for the first class of medical devices catalog and the corresponding in vitro diagnostic reagents classified subdirectory of class I medical devices.
Domestic Class I medical device filing, the filing of municipal food and drug supervision and management departments to submit the record information. Imported Class I medical devices for the record, the filer to the State Food and Drug Administration to submit the record information. Hong Kong, Macao, Taiwan medical equipment for the record, with reference to the import of medical devices.
(C) for the record of imported medical devices, should be filed in the filer's place of registration or production address in the country (region) to obtain marketing authorization for medical devices.
The filer's place of registration or production address in the country (region) is not the product as a medical device management, the filer is required to provide relevant documents, including the filer's place of registration or production address in the country (region) to authorize the product is legally listed on the market for sale of documents.
(d) overseas filers for the record of imported medical devices, should be set up in China through its representative organization or designate the Chinese territory of the enterprise as an agent for the legal person.
(E) the filer shall prepare to record the medical device product technical requirements. Product technical requirements mainly include performance indicators and test methods for finished medical devices.
(F) for the record of medical devices, the filer should be in accordance with the relevant requirements (see Annex 1) to submit the filing information, and the filing of information on the authenticity of the authenticity, completeness, compliance is responsible.
(vii) the record information meets the requirements, the food and drug administration shall be filed on the spot. Record information is incomplete or does not meet the required form, it should be informed of the need to make corrections to all the contents. Not for the record, should inform the filer and explain the reasons.
(viii) to be filed for medical devices, food and drug supervision and management departments should be in accordance with the relevant requirements of the format of the record voucher (see Annex 2), and will be filed in the information table (see Annex 3) in the information contained in the website to be published. Food and drug supervision and management department in accordance with the first class medical device filing operation specification (see Annex 4) to carry out the filing work. The filer shall mark the filing number in the instructions and labeling of medical devices.
(ix) has been filed medical devices, filing information on the content of the table and the filing of the product technical requirements for the record changes, the filer should be submitted to the change in the description of the situation and the relevant documents, to the original filing department to change the filing information. Food and Drug Administration for the record information in line with the formal requirements, should be set out in the change of circumstances in the change of circumstances, the record information on file.
(J) the first class of medical devices filing number is organized as follows:
×1Mechanical preparation ××××2××××3 number.
Which:
×1 for the record of the department of the location of the abbreviation:
Imported Class I medical devices for the "country";
International Class I medical devices for the record of the department of the province, autonomous regions, municipalities directly under the central government for the abbreviation of the municipal administrative region where the city-level administrative region of the abbreviation (no). The corresponding municipal administrative region, only the province, autonomous region, municipality directly under the Central Government for the abbreviation);
××××2 for the record year;
××××3 for the record running number.
Two, has been approved for registration and has been accepted for registration of the project processing
(a) has been approved for registration of the project processing
June 1, 2014 has been approved for registration of Class I medical devices and in the first class of medical devices catalog and the corresponding in vitro diagnostic reagents in the classification of subdirectories, the enterprise should be in the validity of the certificate of registration before the expiration of the record, in accordance with the relevant provisions of the record. Before the expiration of the registration certificate, the enterprise can continue to use the medical device registration review instructions and the original labeling, packaging identification. In the validity of the registration certificate, the original registration certificate contains changes in the content, enterprises should be in accordance with relevant provisions for the record.
June 1, 2014 has been approved before the first class of medical device registration, reclassification belongs to the second or third class of medical devices, enterprises should apply for registration in accordance with relevant provisions.
(B) has been accepted for registration applications for the handling of the project
June 1, 2014 has been accepted before the application for registration of Class I medical devices, food and drug supervision and management departments are no longer registration review. Enterprises to withdraw their own registration applications, food and drug supervision and management department will return all the declaration information to the reporting unit.
Products in the first class medical device product catalog and the corresponding in vitro diagnostic reagent classification subdirectory, the enterprise in accordance with the filing requirements to the corresponding food and drug supervision and management department to file; not in the first class medical device product catalog and the corresponding in vitro diagnostic reagent classification subdirectory, reclassification belongs to the second class or third class of medical devices, the enterprise should be in accordance with the relevant provisions of the application for registration.