Medical device production license number abbreviation

One, the production license number is what it means

Food is generally used QS or SC number, the first paragraph of the number of figures on behalf of the acceptance of the number of institutions, generally for the provincial code; the second paragraph of the number of figures on behalf of the product category, the third paragraph of the number of figures on behalf of the company's code; the production license for industrial products is generally used to indicate the XK, XK on behalf of the license, the first two digits on behalf of the industry, the first two digits on behalf of the industry, the middle three on behalf of the product number, the last five On behalf of the enterprise production license number.

What does the production license number mean

Second, how to apply for a production license

1, application

(1) Enterprises for production licenses must fill out a unified format of the "Production License Application Form" four copies, reported to the Quality and Technical Supervision Bureau of the Business Section.

(2) The enterprise should also provide the following information:

1 business license of the enterprise legal person;

2 routine (type) test reports;

3 environmental protection, health certificates.

(3) Business Section will be all the information after passing the preliminary examination, the application information will be reported to the Quality and Technical Supervision Bureau of Quality, by the Municipal Bureau of unified arrangements for the preliminary examination and inspection.

(4) Municipal Bureau of the preliminary examination of the application materials reported to the Provincial Bureau of Quality and Technical Supervision.

2, acceptance

Provincial Bureau of Quality and Technical Supervision acceptance of the application materials, should be within seven working days to meet the reporting conditions of the enterprise issued a "production license acceptance notice.

3, on-site review

(1) production license implementation rules by the provincial Quality and Technical Supervision is responsible for organizing the enterprise production conditions and sealing of samples, the provincial Quality and Technical Supervision shall accept the application within 2 months after the organization of the production conditions for review and on-site sampling and sealing of samples. Provincial licensing office from the date of acceptance of the application within 3 months from the date of completion of the material summary, and the list of qualified enterprises and related materials reported to the Department of review. Review of the Department of Quality and Technical Supervision from the receipt of the provincial quality and Technical Supervision submitted materials from the date of 45 days to complete the enterprise production conditions and materials summary, and will be qualified enterprises and related materials reported to the National Licensing Office;

(2) Production License Rules for the implementation of the Department of the Ministry of Review of the organization of the production conditions of enterprises to review the sealing of samples, the provincial Quality and Technical Supervision should be admitted to the application of the enterprise within 15 days will be the relevant materials Forwarded to the Department of review. Review Department from the date of receipt of the provincial licensing office to submit the materials within two months from the date of the organization of the production conditions of enterprises applying for licensing review, and on-site sampling and sealing of samples. Review Department from the date of receipt of the provincial licensing office submitted materials within 3 months from the date of the list of qualified enterprises and related materials reported to the National Production Licensing Office;

(3) apply for a license to review the conditions of production of enterprises by the review team to undertake the review group, the review of the implementation of the system of responsibility of the team leader, the review team is responsible for the review report.

4, sample inspection

Application for certification of enterprises should be sealed within 15 days of the sample will be sent to the designated inspection agency. Inspection agency to be samples, should be in accordance with the implementing regulations of the standards and requirements for testing, and should be completed within the specified period of time for testing. Standards for product testing have special requirements, according to the standard provisions. Product testing cycle more than Article XIV time limit for the submission of materials, materials submission time to test the completion of time shall prevail.

5, summary, validation, licensing

National Licensing Office since the receipt of the provincial Quality and Technical Supervision, review of the Department of the summary of the licensing conditions in line with the list of enterprises and the relevant materials within one month from the date of completion of the validation. After validation, meet the licensing conditions, issued by the AQSIQ production license, does not meet the licensing conditions, the reported materials will be returned to the relevant provincial quality and technical supervision or review the Department and inform the enterprise.

6, post-processing

Provincial Quality and Technical Supervision shall not meet the licensing conditions of the enterprise issued a "production license review failed notice", while withdrawing the "production license acceptance notice.

Enterprises since the receipt of the "production license review failed notice" date, it should be seriously rectified, two months before you can apply for a license again.

Third, the validity of the safety production license

Safety production license is valid for three years, in the validity of the annual inspection. According to "Regulations on Safety Production License" Article IX of the safety production license is valid for three years. The validity of the safety production license needs to be extended, the enterprise should be expired three months before the original safety production license issued to the management body for the extension procedures. Enterprises in the validity of the production safety license, strict compliance with laws and regulations related to production safety, the end of fatal accidents, the validity of the production safety license expires, the original production safety license issued by the management body agreed to no longer review the validity of the production safety license is extended for three years.

1, "State Food and Drug Administration" on behalf of the product within the third class of medical devices issued by the State Food and Drug Administration. Note: The same applies to imported Class II and Class III medical device products.

2. "(Quasi) word" on behalf of the domestic medical devices; "2014" is the year of the first registration of the product.

3, "No. 3541699" in the "3" that: the device is a Class III medical device; "No. 3541699" in the "1699". The "1699" in "No. 3541699" means: the registration number of the device is 1699.

4, "No. 3541699" in the "54" means: the device is: operating room, emergency room, diagnosis and treatment room equipment First aid room, diagnostic and treatment room equipment and appliances; (see "State Food and Drug Administration Classification of Medical Devices Catalog").

Second, the medical device registration certificate number coding rules

"Registration of Medical Devices" (State Food and Drug Administration Decree No. 4) for the medical device registration certificate numbering requirements:

1, Article 76 The format of the medical device registration certificate by the State Food and Drug Administration to develop a unified.

The registration certificate number is arranged as follows:

× 1 mechanical note × 2 ××××3 × 4 × 5 ××××6. Where:

× 1 for the registration and approval of the department of the location of the abbreviation:

Domestic Class III medical devices, imports of Class II, Class III medical devices for the word "national"; domestic Class II medical devices for the registration and approval of the department's location of the province:

The registration certificate is issued by the State Food and Drug Administration in accordance with the provisions of Article 76 of the Medical Device Registration Certificate Format. Medical devices for the registration and approval department where the province, autonomous region, municipality directly under the central abbreviation;

× 2 for the form of registration: "quasi" word applies to the domestic medical devices; "into" the word applies to the import of medical devices; "permit" word applies to Hong Kong, China, the United States and other countries. "

××××3 ××××3 for the first registration year;

× 4 for the product management category;

× × 5 for the product classification code;

××××6 ××××6 for the first registration number.

Renewal of registration, ××××3 and ××××6 figures remain unchanged. Product management category adjustment, should be renumbered.

2, Article 77 of the first class of medical devices for the record of the voucher number is organized as follows:

× 1 mechanical preparation ××××2 ××××3 number.

Which:

× 1 for the record of the location of the department of the abbreviation:

imported Class I medical devices for the "national" word; within the first class of medical devices for the record of the department's location of provinces, autonomous regions and municipalities directly under the Central Government for the abbreviation of the location of the municipal administrative region of the abbreviation of the city (without the corresponding municipal administrative region of the city, only the province)

××××2 for the record year;

××××3 for the record running number.

Third, some of the knowledge of the medical device registration certificate number

has been filed medical devices, the record of information on the content of the table and the record of changes in the technical requirements of the product, the record should be submitted to the change in the situation of the description and the relevant documents, to the original filing department to change the filing information. Filing information in line with the formal requirements, food and drug supervision and management departments shall change the information contained in the change, the filing information on file. Re-registration of the original registration certificate is lost, according to the specific circumstances to the relevant departments to apply for a replacement certificate and re-registration at the same time, if it does not meet the conditions at the same time, regardless of the old certificate