Medical device registration certificate expiration and reissue application procedures

Apply for a class of medical device product registration certificate procedures and material requirements a license based on: "Medical Device Supervision and Administration Regulations", "Measures for the Administration of Registration of Medical Devices", "Registration and Approval of Class I Medical Devices in the territory of the Code of Practice (Trial)", "on the issuance of the Interim Provisions for Further Strengthening and Standardization of the Registration of Medical Devices notice" two, the declaration procedure chart Declaration materials: the applicant company to fill in the "application form" should be signed by the legal representative of the company should be complete and accurate. Class I medical device product registration application form" should be signed by the legal representative and stamped with the official seal, the items filled in should be complete and accurate, fill in the content should meet the following requirements:

(1) "Manufacturer Name", "Registered Address" and the "Industrial and Commercial Business License" the same;

(2) "Manufacturer Name", "Registered Address", "Registered Address" and the "Industrial and Commercial Business License" the same. Business License" is the same;

(2) "implementation standards" if the national standard or line standard, directly fill in the national standard / line standard number. If the product registration standards, should fill in the registration standard number of the drug regulatory system for the record.

(3) "product name", "specifications" and the submitted product standards, test reports and other application materials used in the name, specifications consistent.

Three, the medical device manufacturer qualification documents

Qualification documents include "medical device manufacturer license" (or "Class I Medical Device Manufacturer Registration Form") a copy of the "business license" copy.

(1) The product for which registration is applied for shall be within the approved scope of production of the "Registration Form for Class I Medical Device Manufacturing Enterprises" (or "License for Manufacturing Enterprises of Medical Devices");

(2) The documents shall be within the validity period.

Four, the applicable product standards and instructions need to provide electronic text (word format) applicant companies to submit product standards can be national standards, industry standards or registered product standards.

(1) the use of national standards, industry standards as product standards, should be submitted to the adopted national standards or industry standards of the effective text and the adoption of the standard description;

(2) the use of registered product standards as product standards, should be submitted to the official text of the registered product standards and their compilation instructions, evaluation or letter review comments.

Fifth, the full performance of the product test report

The full performance of the product testing can be self-tested or commissioned inspection, but the report should include the following items:

(1) product name, specifications, product number or batch number, date of production, number of samples, the sampling base;

(2) the basis for the test, testing items, standard requirements, test results, results Judgment, inspector, auditor signature or seal, date of inspection, etc.;

(3) If the test is commissioned, it should provide the commissioned test report issued by the testing organization and commissioned test agreement.

Sixth, the enterprise production of products and quality management capabilities of existing resource conditions (including testing methods) description

Enterprise product production of existing resource conditions and quality management capabilities (including testing methods) of the description should include the following:

(1) applying for the enterprise's existing resource (human resources, infrastructure, working environment, etc.) conditions, management capabilities, production capacity, Means of inspection and ability to explain;

(2) provide a list of production equipment, testing instruments and product inspection of measuring instruments required for the valid validity of the verification certificate (copy).

VII, medical device manuals, packaging labels need to provide electronic text (word format)

Medical device manuals should include at least the following:

(1) product name, model number, specifications;

(2) the name of the production company, registered address, production address, contact information;

(3) "Medical Device Manufacturing Enterprise License" (or "Class I"). Enterprise License" (or "Class I Medical Device Manufacturer Registration Form") number, medical device registration certificate number (declaration of the content of the blank), the product standard number;

(4) the performance of the product, the main structure (with a diagram of the structure of the product), the scope of application.

(5) Precautions for use.

VIII, the certificate of registration changes in the description and supporting documents (re-registration applies)

The so-called medical device registration certificate changes in content, refers to the "specifications", "production address", "product standards", "product performance structure and composition", "product scope of application" content of substantive changes.

The description should at least include a comparison of the content before and after the reasons for the change, which should provide the appropriate documents to prove the change in production address.

Nine, the original registration certificate and its annexes (return the original) (re-registration applies)

Copies should be stamped, and indicate "consistent with the original".

Ten, product quality tracking report (re-registration applies)

Product quality tracking report should include the following:

(1) the enterprise's quality control measures for the product and the internal audit of the review of product quality;

(2) in the use of the product, the user feedback on the quality of products;

(3) the product cycle test, daily factory inspection of product quality; product quality supervision and sampling above the provincial level (food) drug supervision and management departments;

(4) the implementation of the adverse event monitoring system and the monitoring of adverse events;

(5) the information collected by the enterprise on product quality, statistical analysis and the measures taken and the validation of the situation.