Food and Drug Administration on the issuance of "medical device business quality management standard on-site inspection guidelines" of the notice
In the wholesale/retail business license for Class 3 medical devices (including changes and continuation of the on-site verification of the business license, the business enterprise to apply the special case all meet the requirements of the "through the inspection ". There are key special cases do not meet the requirements or general special cases do not meet the requirements of the number of special cases > 10% for "failed inspection". Food and drug regulatory authorities based on the review, to make a written decision on whether to grant permission.
How to do medical device business license
The medical device business license is issued by the Food and Drug Administration. You should go to the local city Drug Administration to apply. Application to:
First, the conditions of personnel
1, the legal representative of the proposed enterprise and the person in charge of the enterprise should be familiar with the national and local supervision and management of medical devices regulations, rules and relevant provisions.
2, with its scale of operation and business scope of the quality management organization and professional training and qualified to take up full-time quality management
Second, the business premises and warehousing space conditions
Third, the quality management system
Fourth, the technical training and after-sales service conditions
Fifth, the quality of the management information and files
There are table patterns here!
Chapter III Application for "Medical Device Business Enterprise License" program
Article IX The proposed enterprise location of the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or accept the entrusted municipal (food) drug supervision and management agencies are responsible for accepting the "Medical Device Business Enterprise License" application for issuance of licenses.
Article 10 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or accept the entrusted municipal (food) drug supervision and management agencies should be in its administrative website or application acceptance place to publicize the application for the "medical device business license" required conditions, procedures, deadlines, need to submit all the materials directory and the application form model text.
Article XI of the application for "medical device business license", the following information should be submitted:
(a) "Medical Device Business License Application Form";
(b) the industrial and commercial administration department issued by the business name of the pre-approval of the certificate file;
(c) the proposed quality management personnel's identity card, academic or professional title certification Copy and resume;
(D) the proposed enterprise organization and functions;
(E) the proposed enterprise registered address, warehouse address geographic location map, floor plan (indicating the area), photocopy of the certificate of property rights (or lease agreement);
(F) the proposed enterprise product quality management system files and storage facilities, equipment directory;
(G) the proposed enterprise business management system, business management and management of the quality of the enterprise's products;
(G) the proposed business scope of the enterprise.
Article 12 The applicant shall be to the proposed business location of the province, autonomous region, municipality directly under the Central (food) drug supervision and management department or to accept the entrusted municipal (food) drug supervision and management agencies to make "medical device business license" application for licensing.
For the applicant's "medical device business license" application for licensing, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments or municipal (food) drug supervision and management agencies should be entrusted to deal with the following situations:
(a) the application does not belong to the department's terms of reference, it should be made immediately inadmissible (A) the application does not fall within the purview of the department, shall immediately make a decision of inadmissibility, issued a "notice of inadmissibility", and inform the applicant to the relevant departments;
(B) the application materials can be corrected on the spot there are errors, the applicant shall be allowed to correct on the spot;
(C) the application materials are incomplete or do not meet the statutory form, shall be issued on the spot or within five working days to the applicant "Notice of Rectification", a one-time notice of Need to make corrections to all the contents. Late notification, from the date of receipt of the application materials shall be accepted;
(d) the application falls within the purview of the department, the application materials are complete, meet the statutory form, or the applicant in accordance with the requirements to submit all the corrections to the application materials, issued a "Notice of Acceptance". Notice of acceptance" shall be stamped with the acceptance of the special seal and indicate the date of acceptance.
Article XIII of the provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments or municipal (food) drug supervision and management agencies in accordance with the commissioned area based on the inspection and acceptance of medical equipment business enterprises to do on-site verification of the proposed business, and in accordance with these measures to review the application materials.
Article 14 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments shall, within 30 working days from the date of acceptance, to make a decision whether or not to issue a "medical device business license". Considered to meet the requirements, shall make a decision to grant the issuance of "medical device business license", and within 10 days of the date of the decision to the applicant to issue "medical device business license". That does not meet the requirements, shall notify the applicant in writing, and explain the reasons, while informing the applicant of the right to apply for administrative reconsideration or administrative litigation.
Article 15 (food) drug supervision and management department of the applicant's application for review, shall publicize the approval process and approval results. The applicant and interested parties may submit written comments on matters directly related to their vital interests for statement and defense.
"Medical Device Business License" application directly involves the applicant and others with significant interests, (food) drug supervision and management department shall inform the applicant and interested parties shall enjoy the right to apply for a hearing.
(Food) drug supervision and management department that the "medical device business license" involves public **** interests, it should be announced to the community, and hold a hearing.
Article 16 Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department shall publish the issued "medical device business license" information, the public has the right to query
Hope to adopt, thank you.
How to log out of a Class I medical device license
Similar to the second and third class medical device license log out program, fill out the application form, bring the original business license, bring the ID card, provide proof that there is no violation of the law being investigated and dealt with in the remaining list of commodities and processing instructions, and so on. The company's website is a great place to find out more about the company's services, and it's a great place to learn more about the company's services.
How to apply for a medical device license?Before applying for a good 1, business management files; 2, business premises (warehouse address); 3, the relevant personnel; 4, business premises to plan the area; 5, the personnel of the original academic or relevant certificates of record, and so on.
The specific requirements of the business site how much to see your location of the provincial Drug Administration or municipal office guide on the requirements, of course, if you apply for the operation of the category is a high level of your personnel requirements are higher, you will be based on the resources at hand to declare it, do not all at once require all the application down after the application has the requirements to apply for a change in license, if you do not understand I recommend that you do a good job calling your local Drug Administration for advice. The location of the Drug Administration to consult. p> A: found, as follows:
6801 basic surgical instruments
1: medical suture needles (without thread)
2; basic surgical knives:
Surgical knife handles and blades, scalpel knives, wart stripping knives, lancets, spatulas, shaving knives, dandruff scraping knives, picking knives, sharp knives, pedicure knives, manicure knives, scalpels
p> 3: basic surgical scissors
General surgical scissors, tissue scissors, comprehensive tissue scissors, dismantling scissors, plaster scissors, anatomical scissors, gauze bandage scissors, educational surgical scissors
4: basic surgical forceps
General hemostatic pliers, small blood vessel hemostatic pliers, mosquito hemostatic pliers, tissue pliers, tungsten carbide inserted needle holders, general needle holders, traumatic folder suture removal pliers, panel rolling pliers, Bullet forceps, gauze stripping forceps, sponge forceps, pashmina forceps, skin tube forceps, instrumentation forceps
5: basic surgical forceps
small blood vessel forceps, non-invasive forceps, tissue forceps, orthopedic forceps, needle forceps, health care forceps (simple tweezers), plucking tweezers, pashmina forceps, dressings tweezers, anatomical tweezers, hemostatic clamps
6: basic surgical needles and hooks
Aneurysm needles, probing needles, Aneurysm needles, probing needles, implant needles, picking needles, straight pointed needles for teaching, venous pulling hooks, incision hooks, flat pulling hooks, double-ended pulling hooks, panel pulling hooks, dissecting hooks
7: Other instruments for basic surgery
Blade grippers, anesthesia masks, anesthesia openers, illuminated suction heads, acne removers, acne blackheads extractors, panel scraper, panel scraper, panel scraper, panel scraping and scratching examiners, panel examiner, panel tissue drills, panel examiner, panel examiner, and panel examiner. Ruler, Panel Tissue Driller, Cotter, Cotton Roll
6810 Orthopaedic (Orthopaedic) Surgical Instruments
1: Orthopaedic (Orthopaedic) Surgical Knives and Awls
Vertebral Spatula, Vertebral Files, Hand Awls
Screw Awls, Medullary Reamers, Pressurized Threaded Nail Reamers, Amputation Knives, Osteotomy Knives, Tibial Cutting Knives, Plaster Knives, Tibial Cutting Tools, Hip Joints Forming concave-convex drills, drills, reaming drills, pistol-type hand-operated bone drills
2: Orthopedic (orthopedic) surgical scissors
Bi-articular sphenoidal bone scissors, bi-articular bone clipping scissors, bone scissors, ligamentous knee surgical scissors, plaster scissors, wire scissors
3: Orthopedic (orthopedic) surgical forceps
Cervical spine bite bite forceps, cervical spine bi-articular bone clipping forceps, scoliosis correction forceps, medullary Nucleus forceps, vertebral plate biting bone forceps, curved head flat mouth sphenoid bone forceps, gun-shaped biting bone forceps
Knee polyp forceps, biting bone forceps, bone holding forceps, bone rotting forceps, reset forceps, holding nails forceps, holding plate forceps, holding bar forceps, holding hooks forceps, screw clamping forceps, holding pliers, compression forceps, gun-shaped sampling forceps, bone Kesi forceps, plate bending forceps, steel wire forceps
4: Orthopedic (Orthopaedic) Surgical saws, chisels and files
Circular saws, lumbar spine, lumbar spine, spine, spinal cord and other surgical instruments.
Circumferential saw, trapezoidal bone chisel for lumbar spine, circumferential saw for intervertebral disc surgery, C-D vertebral plate peeler, cervical depth-finding chisel, cervical right-angled bone chisel, vertebral bone chisel, vertebral bone chisel, vertebral bone chisel, vertebral anterior body peeler
Archesaw, fingersaw, bone saw, small garden scraping chisel, ding-dong chisel, bone file, curved chisel, hip molding chisel, casting saw, trapezoidal spatula, humerus molding chisel for elbow joints 5: Hooks and pins for orthopedic surgery
Hooks and pins for orthopedic surgery
Hooks and pins for unilateral laminae, meniscus hooks, lower extremity amputation hooks, bone hooks, cervical hooks, deep anterior cervical suture pins, bone retraction pins, pressurized threaded nail guide pins
6: Scrapes for orthopedic surgery
Scraping spoons for cervical vertebrae, variable nerve strippings Cervical spine spatula, variable nerve dissection device, spatula, periosteal dissector
7: Orthopedic (orthopedic) surgical active instruments
Wind-operated craniotome, battery-operated self-stopping cranial drills, electric sternum saws, electric bone drills
Electric plaster scissors, electric plaster saws
8: Orthopedic (orthopedic) surgical other instruments
Extension frames, multi-functional unilateral external fixation Brace
Please adopt, thank you.
Medical device license address change
Well, the need for on-site verification and acceptance.
First, the licensing program:
"Medical Device Business License" program change
Second, the license is based on:
"Supervision and Administration of Medical Devices Regulations", "Supervision and Administration of Medical Devices Business", "supervision and management of single-use sterile medical devices (Interim)", "disposable use of sterile medical devices business enterprise", "implementation rules for the recognition of qualifications (Interim)", "disposable use of sterile medical devices business enterprise", "medical devices business enterprise", "medical devices business enterprise", "medical devices business enterprise". Qualification Accreditation Implementation Rules (Interim)", "local" supervision and management of medical devices business enterprise "implementation rules"
Third, the scope of acceptance:
Change of enterprise name, registered address, business address, legal representative (responsible person), product range, etc.
Fourth, the declaration of information:
"local medical device business enterprise application form for changes
(a) on the change of matters relating to the approval of the higher authorities file or board of directors resolution or the need to invest in the corresponding file issued by the investor, etc.
(b) the relevant reporting materials
1, change of business name: a new business license or the administrative department of industry and commerce issued a photocopy of the "Notice of Approval of Change of Business Name".
2, change of address: proof of property rights or proof of property rights + photocopy of the lease contract, geographic location map and floor plan
3, change of product range: a) increase the product range of the same as the start-up enterprises; b) the operation of medical devices require special management of varieties, in accordance with the relevant provisions of the application for processing (eg: the operation of single-use sterile medical devices need to comply with the National Bureau of Order No. 24) (The requirements of the implementation of the rules).
V. Procedures:
Provincial acceptance - material review - on-site review (licensing matters according to the licensing standards entrusted to the municipal review) - Provincial Board Decide whether the license is granted to change
Six, the time limit:
Thirty working days
Seven, the acceptance of the location:
Provincial Food and Drug Administration administrative licensing for the Office of the
Medical Device License changes include what?Medical device license can be divided into two special changes in licensing and registration changes. Medical device license license changes include quality management personnel, registered address, business scope, warehouse address (including the increase or decrease of warehouse) changes. The change of registration of medical device license refers to the change of other matters other than the above. For more information, please visit the official website of AuZhida Medical Devices Service Group.
The difference between a medical device registration certificate and a medical device license
A medical device registration certificate is a legal ID for a product, and a medical device license is a legal permit to operate a product.
The original three types of medical device license expired how to replaceGo to the Drug Administration website to submit an application, and then prepare materials to the Drug Administration or Drug Administration window, if the procedures are complete, and so on the door acceptance and examination. If the material is not complete, people will not accept, and then come back to prepare materials. Specific materials required by each Drug Administration is different, go to the local Drug Administration to consult. The first thing you need to do is to get your hands on a new one.