First, the "medical equipment production supervision and management approach" (hereinafter referred to as the production approach) Revision of the general idea of ​​what is?
A: safe and effective medical devices relating to people's lives and health, medical equipment production process directly affects the quality and safety of the product. As one way of supporting the production regulations "Supervision and Regulation of Medical Devices"

(hereinafter referred to as the "Regulations"), and in the revision of the general idea, mainly to the following three points: First, follow the "Regulations" Risk management and category management principles ,In the specific design of the system on prominent scientific management; the second is to learn from foreign advanced supervisory experience, considering the current medical device regulatory basis, reflecting the operability; Third, the market maturity and the social credit system in our country's economic and social situation at the present stage, pay attention to mobilize and play the main responsibility of enterprises, build enterprise-oriented product quality security system, reflect management's introductory.

Second, the revised production approach reflects what principles?
A: The new revised production approach embodies the following principles: First, the risk management. Production behavior of different risk classification management, improve the regulatory classification measures, highlighting the high-risk behavior of strict production management. The second is to implement the principle of responsibility. Refining production quality management measures, in accordance with the requirements of medical device manufacturing enterprise quality management standard requires the establishment of quality management system and to maintain effective operation, the implementation of corporate self-examination and reporting system, and urge enterprises to implement the main responsibility. The third is to strengthen the principles of supervision. Through the integrated use of random testing, quality bulletin, flight inspection, interviews responsibility, "blacklist" and other systems, rich regulatory measures to improve the means of supervision, promote the implementation of regulatory responsibility. Fourth, the principle of strict at illegal. Improve the legal responsibility of the relevant acts, detailed types of penalties, and increase penalties for violations aggravation.

Third, the start-up medical device manufacturers should have what conditions?
A: The start of medical device manufacturer shall meet the following conditions: First, there is the production of medical devices to the production sites, environmental conditions, production equipment and professional and technical personnel. Second, there is on the production of medical devices for quality inspection agency or professional inspectors and inspection equipment. Thirdly, it is to ensure that medical device quality management system. Fourth, there is after-sales service capacity and production of medical equipment to adapt. Five is in line with the requirements of product development, manufacturing process documents stipulated. These conditions are set up medical device manufacturer of the basic conditions, but also the regulatory authorities in accordance with the medical device GMP production license to carry out the core content site verification.

Fourth, what form "medical equipment production license" is?
A: The "medical equipment production license" is valid for 5 years, states the license number, company name, legal representative, responsible person, residence, address production, production range, issuing department, issuing date and the expiration date and other matters .
"Medical equipment production license" attached medical device manufacturing product registration form, specifying the production of the product name, registration number and other information.

Fifth, how to apply for start-up medical device manufacturers?
A: The start of the first class of medical device manufacturers, the manufacturer shall submit the enterprise held by the production of medical equipment registration certificate and copies of business license, organization code certificate, a copy of proof material corporate officers, Production sites photocopy documents, quality documents and other archival materials to the food and drug administration departments and municipal districts handle location first class medical equipment production record.
Open a second Class III medical device manufacturers, the manufacturer shall submit the production of medical equipment registration certificate and business license, organization code certificate, business people supporting documents held by the enterprise copies application material pieces, production sites photocopy documents, quality documents, etc., to the provinces, autonomous regions and municipalities food and drug administration departments to apply for production licenses.

Sixth, commissioned the production of medical equipment should have what conditions?
A: The medical equipment commissioned the production of the Principal shall be commissioned the production of medical devices within the registrant or the filer. Among them, the commission does not belong to the production of innovative medical devices in accordance with the special approval process within the medical device approval, the commissioning party shall obtain commissioned the production of medical equipment production license or apply for a first class medical equipment production record.
Commissioned the production of medical devices trustees should be entrusted with the production of medical equipment to obtain the appropriate license or produce a range of produce handled first class medical equipment production record of domestic manufacturing enterprises.

Seven commissioned the production of medical devices which prohibit or qualifications?
A: Principal in the same period of the same medical products only commissioned a medical equipment manufacturing enterprises for production, but the commission except absolute control of enterprises. In addition, a high risk of implantable medical devices can not be commissioned production. China Food and Drug Administration "ban on publication commissioned the production of medical equipment directory notice" (2014 No. 18 announcement), expressly prohibiting commissioned the production of medical devices directory.

VIII commissioned the production of medical devices should go through?
A: Trust Class II, Class III medical devices, the commissioning party should handle the commissioned production for the record to the provinces, autonomous regions and municipalities food and drug administration departments; entrust production of the first class of medical devices, the commissioning party shall set the location Municipal Food and Drug administration area entrusted to handle the production record. Subject to conditions, the food and drug administration department shall issue registration certificate commissioned the production of medical devices.
Trustee shall, by Principal Principal production registration certificate, the original issuing department to the trustees for a production license or change the original filing department for first class medical equipment production record changes in their production product registration form or the first class of medical equipment production record certificate fiduciary increase production products.

Nine, medical device manufacturers to increase production when the product should go through?
A: The medical equipment manufacturer to increase production of the first class of medical devices, shall go first class medical device manufacturers to change the record or the record.
Medical equipment manufacturing enterprises to apply to increase production II and Class III medical devices shall submit the proposed increase in the product registration certificate and other materials. Application to increase production of the product does not belong to the scope of the original production, the original issuing department shall be subject to review and conduct on-site verification of compliance with the conditions, set out to change the production license production ranges and products in the production of products posted registration form information. Application to increase production of goods belonging to the scope of the original production, but production technology and production conditions of the original permit production of products materially different requirements, in accordance with the provisions of the original issuing department shall review and on-site verification of compliance with the conditions in the production product registration table published product information. Application to increase production of products belong to the original scope of production and production technology and production conditions of the original permit requirements similar products produced, the original issuing department shall review the application materials, compliance with the conditions, posted in the production of goods and registration form product information.

Ten, production approach to the production and export of medical device companies have regulations?
A: The production and export of medical devices, shall ensure that the production of medical devices meet the requirements of the importing country (region), and product-related information filed with the municipal food and drug administration departments seat districts. Related topics including export products, production enterprises, export enterprises, sold to countries (regions) and whether overseas enterprises commissioned the production of other information.
Accept foreign enterprises commissioned the production marketed overseas medical devices, manufacturers should obtain medical device quality management system of third-party certification or license, or similar products produced within the record.