Medical device manufacturing license should be renewed in what to handle

Medical device license for the continuation of the continuation of how to operate? We all know that any expiration of a qualification should be applied for continuation or renewal, medical device license is no exception. How to do that, what materials need to bring?

First, for the continuation of the medical device license process:

1, the applicant logged on to the medical device enterprise service platform, apply, fill in the information, submit the information, receive the acceptance number;

2, the person to the jurisdiction of the Administrative Licensing Service Center Markets and Quality Supervision Bureau window with the acceptance number of the application materials, the window staff to receive and check the application materials, application materials are complete and meet the legal form, issue the application materials, and the application materials are complete and meet the legal form, the application materials are complete and meet the legal form, issue the application materials. Meet the statutory form, issue a "Notice of Acceptance" and inform the applicant needs on-site inspection; application materials are incomplete or do not meet the statutory form, on the spot to inform the applicant needs to make corrections to all the contents and standards;

3, the District Markets and Quality Supervision for review, in the "Medical Device License" before the expiry of the validity period to make a decision on whether or not to grant the continuation of the conditions set out in the continuation of the granted! Permitted to continue to notify the applicant to receive a new license, return the original license. Does not meet the prescribed conditions, ordered to rectify; rectification still does not meet the prescribed conditions, not renewed, and a written explanation of the reasons, inform the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law. Failure to make a decision after the deadline, deemed to be allowed to continue. No continuation of the "medical device license" shall be canceled at the expiration of the original license, explain the reasons.

Second, the continuation of the medical device manufacturing license conditions:

(1) hold the enterprise's "medical device registration certificate";

(2) with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel; the enterprise should have with the production of products and the production scale of production equipment, production, warehousing sites and environment. Enterprise production of medical devices on the environment and equipment and other special requirements, should be in line with national standards, industry standards and relevant state regulations;

(3) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment; enterprise production, quality and technical personnel should have with the production of medical devices to adapt to the professional competence, and master the national laws, rules and regulations on the supervision and management of medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices and medical devices, medical devices, medical devices and medical devices. Supervision and management of laws, rules and regulations and related product quality, technical regulations, the person in charge of quality shall not be concurrently responsible for the production;

(4) have to ensure that the quality of medical devices management system;

(5) with the production of medical devices compatible with the after-sales service capacity;

(6) in line with the requirements of product development, production process documentation;

(7) enterprise Should be preserved with the production and operation of medical devices related laws, regulations, rules and relevant technical standards.

Third, for the continuation of the medical device manufacturing license required materials:

(1) "Medical Device Manufacturing License Renewal Application Form";

(2) the old version of the "Medical Device Manufacturer License" original, original copy and a copy of the registration certificate of the medical device or a new version of the "Medical Device Manufacturing License" and "Medical Device Manufacturing Product Registration Form" (change of production address does not need to be provided) the original

(3) business license, organization code certificate copy of the original and a copy;

(4) municipal bureau issued by the production of medical devices on behalf of the manager to confirm the notification of filing;

(5) the authenticity of the application materials, self-assurance statement, including the directory of materials applied for and the enterprise to make a commitment to the material, if false to bear the legal responsibility of the commitment; the application for the inspection of the confirmation letter.

(6) Where the application for corporate filings, the person in charge is not the legal representative or person in charge of himself, the enterprise should submit a "power of attorney".

Changshun enterprise, medical device record industry professional registration certificate agent, 15 years of experience in team medical equipment consulting services, 300 + people business team, expedited for a class of Class II Class III medical device documents, green channel, 10 days package to get the certificate.