Medical device license extension how to handle

District Market and Quality Supervision Bureau in the "Medical Device Business License" before the expiration of the validity of the decision on whether or not to grant the continuation of the conditions, grant the continuation of the continuation of the notification of the applicant to receive a new card, return the original card. 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 for informing 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 granted the continuation. Not renewed shall be in the "Medical Device License" expiration of the original certificate shall be canceled, stating the reasons.

Medical device manufacturing license renewal 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 scale of production of production equipment, production, warehousing space and environment. . Enterprises producing medical devices with special requirements for the environment and equipment, should be in line with national standards, industry standards and relevant state regulations;

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

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

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

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

(7) the production of medical devices, the production of medical devices and medical devices;

(8) the production of medical devices and medical devices;

(9) the production of medical devices;

(10) the production of medical devices, medical devices and medical devices Requirements;

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

Materials required for the continuation of the medical device manufacturing license

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

(2) the old version of the "Medical Device Manufacturer's License" original, original 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 is not required to provide) original;

(3) "Medical Device Manufacturing License" original and "Medical Device Manufacturing License" and "Medical Device Manufacturing Product Registration Form" (change of production address is not Need to provide) original;

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

(4) municipal bureau issued by the medical device production manager representative of the filing of a copy of the confirmation notice;

(5) the authenticity of the application materials of the self-assurance statement, including the directory of the application materials and the enterprise on the materials to make a commitment to bear legal responsibility for any false;

(6) the application materials, including the application materials and materials to make a commitment to bear legal responsibility for any false. Application for inspection confirmation.

(6) Where the application for the enterprise to declare the material, the person handling the material is not the legal representative or person in charge himself, the enterprise should submit the "power of attorney".

Legal basis:

"The People's Republic of China*** and the Basic Medical Care and Health Promotion Law" Article 99 Violation of the provisions of this law, without obtaining a license to practice as a medical institution without authorization to practice, by the competent departments of the people's governments at or above the county level of health and health ordered to stop practicing, confiscate the illegal income and medicines, medical equipment. It shall also impose a fine of not less than five times but not more than twenty times the illegal income, and if the illegal income is less than ten thousand yuan, it shall be calculated at ten thousand yuan. Violation of the provisions of this Law, forgery, alteration, trading, leasing, lending of medical institutions practice permit, by the people's governments above the county level, the competent department of health and health ordered to correct, confiscate the illegal income, and impose a fine of more than five times the illegal income of fifteen times the illegal income, the illegal income of less than ten thousand yuan, according to the calculation of ten thousand yuan; the circumstances are serious, the revocation of the license to practice medical institutions.