Article VII engaged in the production of medical devices, shall have the following conditions: (a) with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel; (b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment; (c) have to ensure the quality of medical devices management system; (d) with the production of medical devices compatible with after-sales service capabilities; (e) meet the requirements of product development and production process documentation. (D) with the production of medical devices compatible with the after-sales service capabilities; (E) meet the requirements of product development, production process documentation.
Article VIII of the second class, the third class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to apply for production permits, and submit the following information: (a) business license, organization code certificate copy; (b) the applicant holds the production of medical devices and product registration certificate and a copy of the technical requirements of the product; (c) the legal representative, (C) legal representative, a copy of the identity of the person in charge of the enterprise; (D) production, quality and technical personnel of the identity, education, title certificate copies; (E) production management, quality inspection positions, staff education, title list; (F) production site documents, there are special requirements for the production environment should also be submitted to the facilities, the environment of the copy of the documents; (VII) the main production equipment and inspection equipment catalog; (VIII) quality manual and procedure documents; (VIII) the quality manual and procedure documents; (VIII) the quality manual and procedure documents; (VIII) the quality manual and procedure documents (H) quality manuals and procedural documents; (I) process flow diagrams; (J) proof of authorization of the operator; (K) other supporting information.
Article IX Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration received an application, shall be dealt with in accordance with the following: (a) the application is within the scope of its competence, the application information is complete, in accordance with the statutory form, the application shall be accepted; (b) the application information is incomplete or does not comply with the statutory form, it shall be informed of the applicant need to make corrections to all the contents of the application, or within five working days, on the spot or at one time. (B) the application information is incomplete or does not meet the statutory form, the applicant shall be informed on the spot or within five working days of the need to make corrections to all the contents of the late notification, since the date of receipt of the application information is accepted; (C) the application information can be corrected on the spot errors, the applicant should be allowed to correct on the spot; (D) the application does not fall within the purview of the department, it should be immediate inadmissibility of the decision, and inform the applicant to the relevant administrative departments to apply. Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration acceptance or inadmissibility of applications for authorization to manufacture medical devices, shall issue a notice of acceptance or inadmissibility.
Article X Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall, within 30 working days from the date of acceptance of the application information for review, and in accordance with the requirements of the quality management standard for the production of medical devices to carry out on-site verification. On-site verification should be based on the situation, to avoid duplication of verification. If rectification is required, the rectification time shall not be counted as the time limit for audit. Meet the prescribed conditions, according to law to make a written decision to grant permission, and within 10 working days to the "Medical Device Manufacturing License"; does not meet the prescribed conditions, make a written decision not to permit, and the reasons.
Article XI of the first class of medical equipment manufacturers, should be located in the municipal food and drug supervision and management department for the first class of medical equipment production record, submit a copy of the filing of the record held by the company to produce medical devices for the record vouchers and the information provided for in Article 8 of these measures (except for the second item). Food and drug supervision and management department shall be on the spot on the integrity of the information submitted by the enterprise to check, in line with the prescribed conditions to be filed, issued by the first class of medical devices production filing vouchers.
Article XII of the medical device production license application directly involves the applicant and others with significant interests, the food and drug supervision and management department shall inform the applicant, the interested party in accordance with the laws, regulations and the relevant provisions of the State Food and Drug Administration to enjoy the right to apply for a hearing; in the review of the medical device production license, the food and drug supervision and management department that involves public **** interests of significant licenses. Public **** interests of major licensing matters, shall be announced to the community, and hold hearings.
Article XIII of the "Medical Device Manufacturing License" is valid for five years, set out the license number, enterprise name, legal representative, responsible for the enterprise, residence, production address, production range, the licensing department, the date of issuance and validity period and other matters. Medical Device Manufacturing License" attached to the medical device production product registration form, containing the name of the production product, registration number and other information.
Article XIV of the increase in the production of products, medical device manufacturers should be submitted to the original licensing department of the provisions of Article VIII of these measures involves a change in the content of the relevant information. Application for increased production of products does not belong to the original scope of production, the original licensing department shall, in accordance with the provisions of Article X of these measures to review and carry out on-site verification, meet the prescribed conditions, change the "medical device production license" set out in the scope of production, and in the production of medical equipment product registration form in the registration of product information. Application for increased production of products belonging to the original scope of production, and the original license to produce products with similar production processes and production conditions and other requirements, the original licensing department shall audit the declaration information, meet the prescribed conditions, in the production of medical devices product registration form in the registration of product information; and the original license to produce products with substantially different production processes and production conditions, shall be in accordance with the provisions of Article 10 of the present measures Audit and carry out on-site verification, meet the prescribed conditions, in the medical device production product registration form to register product information.
Article XV of the production of non-textual changes in the address, shall apply to the original licensing department to change the production of medical devices license, and submit the provisions of Article VIII of these Measures involves a change in the content of the relevant information. The original licensing department shall, in accordance with the provisions of Article X of these measures to review and carry out on-site verification, within 30 working days to make the decision to grant the change or not change. Medical device manufacturers across provinces, autonomous regions and municipalities directly under the Central Government to set up production sites, should apply for a separate medical device production license.
Article XVI of the enterprise name, legal representative, the person in charge of the enterprise, residence changes or textual changes in the production address, medical device manufacturers should be changed within 30 working days after the change to the original licensing department for the "Medical Device Manufacturing License" to change the registration and submit the relevant departments of the supporting information. The original licensing department shall promptly handle the change. Changes in the information is incomplete or does not meet the formal review of the provisions, should be informed of the need to make corrections to all the contents of a time.
Article XVII of the "Medical Device Manufacturing License" expiration of the continuation of the medical device manufacturers should be valid since the expiration of six months before the original licensing department for the "Medical Device Manufacturing License" renewal application. The original licensing department shall, in accordance with the provisions of Article 10 of the continuation of the application for review, on-site verification, if necessary, in the "Medical Device Manufacturing License" before the expiration of the validity of the decision on whether to grant the continuation. Meet the prescribed conditions, the continuation is granted. Does not meet the prescribed conditions, ordered to rectify; rectification still does not meet the prescribed conditions, not to continue, and a written explanation of the reasons. Failure to make a decision after the deadline, deemed to be granted continuation.
Article XVIII due to the separation, merger and survival of medical device manufacturers, shall apply for a change of license in accordance with the provisions of these measures; due to the separation of enterprises, mergers and dissolution of medical device manufacturers, shall apply for cancellation of the "Medical Device Manufacturing License"; due to the separation of enterprises, the merger of the newly established medical device manufacturers shall apply for the "Medical Device Manufacturing License".
Article 19 of the "medical device production license" lost, medical device manufacturers should immediately in the original licensing department designated by the media to publish a statement of loss. Since the date of publication of the statement of loss of 1 month, to the original licensing department to apply for reissue. The original licensing department in a timely manner to reissue the "medical device manufacturing license".
Article XX changes, reissued "medical device production license" number and validity period remains unchanged. Renewal of the "medical device production license" number unchanged.
Article 21 of the first class of medical devices production certificate for the record changes in content, should be changed for the record. Record evidence of loss, medical device manufacturers should be timely to the original record department for reissue procedures.
Article 22 of the production of medical devices due to illegal production of food and drug supervision and management departments to investigate the case has not yet been closed, or received an administrative penalty decision but has not yet been fulfilled, the food and drug supervision and management department shall suspend the license until the case is completed.
Article 23 of the medical device manufacturers have laws and regulations should be canceled circumstances, or the validity period has not expired but the company took the initiative to cancel, the provinces, autonomous regions and municipalities directly under the central food and drug supervision and management department shall be canceled according to law, "Medical Device Manufacturing License", and be published on the website.
Article 24 Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration shall establish the "medical device production license" issued, continuation, change, reissuance, revocation and cancellation of the license file. Municipal food and drug supervision and management department shall establish the first class medical device production record information files.
Article 25 No unit or individual shall not forge, alter, buy, sell, lease, lend "medical device production license" and medical device production record vouchers.