Hello, in the "medical equipment procurement management system" has this provision:
4.1 Medical equipment purchase must adhere to the "purchase on demand, the purchase of the best" principle, to comply with relevant state laws and regulations, to ensure product quality.
4.2 Purchasers must have a business license issued by the industry and commerce department, and has a valid "Medical Device Manufacturer's License" or "Medical Device Operator's License" of the enterprise to purchase qualified medical devices, and inspection of the product certification.
4.3 Procurement of domestic products must have a valid "Chinese People's Republic of China *** and the country's medical device registration certificate" and medical device product manufacturing approval form, while the product must be in the supplier's "Medical Device Manufacturer's License" or "Medical Device Operator's License" within the scope of the product. If necessary, the product and enterprise quality system inspection.
4.4 Procurement of imported products must have a valid "Chinese People's Republic of **** and the country's medical device registration certificate" and medical device product registration form, while the product must be in the supplier's "Medical Device Business Enterprise License" within the scope of the product.
4.5 The first time the varieties of business should establish a quality audit system. Quality audit includes: request for product technical standards, sign a quality assurance agreement, and establish a procurement contract file.
4.6 Purchasers shall not purchase products of substandard quality, shall not purchase expired, invalid or state-ordered out of medical devices.
4.7 Purchase of medical equipment to have legal bills, and the establishment of a complete, true purchase records, tickets, accounts, goods consistent.
4.8 Enterprises are required to operate all varieties of product qualifications and the qualifications of its suppliers, the production of catalogs and the formation of files, properly preserved. Regularly also need to check the validity of the qualification, timely update.
I hope the above will be helpful to you
How to query the China Medical Device LicenseOn this:sfda.gov.State Food and Drug Administration, find:app1.sfda.gov./datasearch/face3/base.jsp?tableId=26&; tableName=TABLE26&title=Domestic Devices&bcId=118103058617027083838706701567
Is a wheelchair considered a medical device? Do I need a medical device license to operate a wheelchair?Wheelchairs are medical rehabilitation equipment! The wheelchair is a medical device that requires a medical license! But you don't need a medical device registration certificate! The center of the disabled service center also sells them! (that is, the Disabled Persons' Federation)
Purchasing equipment without a medical device license will be punishedArticle 42
Violation of the provisions of this regulation, the medical institutions to use no product registration certificates, no certificate of conformity, expiration, expiration, elimination of medical equipment, or from the absence of the "Medical Device Manufacturer's License", "Medical Device Business License" of the enterprise purchase of medical devices, by the county of the county, the medical device manufacturer's license. Medical devices, by the people at or above the county level *** Drug supervision and management department shall order correction, give a warning, confiscate the illegal use of products and illegal income, illegal income of more than 5,000 yuan, and impose illegal income of more than two times five times the fine; no illegal income or illegal income of less than 5,000 yuan, and impose a fine of more than 5,000 yuan of 20,000 yuan; the competent personnel and other directly responsible personnel shall be subject to the law. Supervisors and other directly responsible personnel shall be given disciplinary action; constitutes a crime, shall be investigated for criminal responsibility.
Which eight medical device license change in HenanThe applicant to the Provincial Food and Drug Administration to change the application, and submit the relevant materials:
(1) "Medical Device Business License Change Application Form" two copies;
(2) "Medical Device Business License" original and copy;
(3) Business License copy;
(4) change of enterprise name, need to provide the administrative department for industry and commerce issued the "notice of approval of the change of enterprise name";
(5) change of legal representative, need to provide the shareholders' resolution, personnel appointment and dismissal decision and a copy of ID card;
(6) change of the person in charge of the enterprise, need to provide the decision on the appointment and dismissal of personnel, resume, copy of ID card
(7) change of quality management, need to provide the new quality management letter of appointment, personal resume, education and qualification certificates, copies of identity cards;
(8) change of registered address, need to provide floor plan and proof of property rights or the right to use the house, geographic location map and description of the storage conditions;
(9) change of the warehouse address, need to provide the layout plan (10) change the scope of business, should be submitted at the same time to operate a copy of the product registration certificate and the corresponding storage conditions (reduce the scope of business, do not need to provide the information required under this item);
(11) the applicant of the authenticity of the materials submitted to the self-assurance statement The applicant's self-assurance statement of the authenticity of the submitted materials.
Renewal of the "Medical Device License" report how to write
What continuation?
It is the expiration of the license to renew it, go directly to your city Drug Administration for the renewal of the license on the line.
But to prepare for the declaration of materials, you can in your city Drug Administration online query specifically to submit what information
How much does it cost to handle the medical equipment business licenseDepending on what kind of medical equipment license you do, it is a class II or class III, the price is not the same. And the scope of the license, the place of registration and so on all affect the cost of processing.
Download the "Medical Device Business License" change application
On the local red shield network can be downloaded
Jiaozuo have a medical device business licenseNo, and again, on behalf of the medical device business license is illegal, if found, entrusted to the business enterprise will also be implicated, will be revoked license.
What is the query method for the medical device license?
The medical device license should generally be handled by the municipal bureau, you can check the website of the municipal Drug Administration