In the on-site verification of the business license (including change and extension) of the third category of medical device wholesale/retail enterprises, all the items applicable to the enterprises meet the requirements are "qualified". If there are key projects that do not meet the requirements or the number of projects that do not meet the requirements in general projects is > 10%, it is considered as "unqualified inspection". The food and drug supervision department shall make a written decision on whether to approve the license according to the review.
How about Hefei medical device business license? The Medical Device Business License is issued by the Food and Drug Administration. You should apply to the local US Food and Drug Administration. When applying, you should:
I. Personnel conditions
1, the legal representative of the proposed enterprise and the person in charge of the enterprise should be familiar with the national and local regulations, rules and regulations on the supervision and management of medical devices.
2, there are quality management institutions and professional training qualified full-time quality management positions that are suitable for its business scale and scope.
Second, the business premises and storage conditions
Third, the quality management system
Four, technical training and after-sales service conditions
V. Quality Management Information and Documents
There is a table mode here!
Chapter III Application Procedures for Business License of Medical Devices
Article 9 The (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the applicant enterprise is located or the entrusted (food) drug supervision and administration department of the city divided into districts shall be responsible for accepting the application for the issuance of the Medical Device Business License.
Article 10 The (food) drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government or the entrusted (food) drug supervision and administration department of a city divided into districts shall publicize the required conditions, procedures, time limit, all materials to be submitted and the model text of the application on the website of the administrative organ or the place where the application is accepted.
Article 11 The following materials shall be submitted when applying for the Medical Device Business License:
(1) Application Form for Medical Device Business License;
(2) The certificate of pre-approval of enterprise name issued by the administrative department for industry and commerce;
(three) the identity card, education or professional title and resume of the quality management personnel of the enterprise to be established;
(4) The organizational structure and functions of the proposed enterprise;
(five) the registered address of the proposed enterprise, the geographical location map, floor plan (indicating the area) and the copy of the property right certificate (or lease agreement) of the warehouse address;
(six) the product quality management system documents and storage facilities and devices of the enterprise to be established;
(7) The business scope of the proposed enterprise.
Article 12 An applicant shall apply to the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the enterprise to be applied for is located or the (food) drug supervision and administration department of the city divided into districts entrusted by it for issuance of the Medical Device Business License.
For the applicant's "Medical Device Business License" application, the (food) drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government or the entrusted (food) drug supervision and administration institution of the city with districts shall deal with it respectively according to the following circumstances:
(a) the application matters do not belong to the scope of authority of the department, it shall immediately make a decision not to accept, send a notice of rejection, and inform the applicant to apply to the relevant departments;
(2) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;
(3) If the application materials are incomplete or do not conform to the statutory form, the applicant shall issue a Notice of Supplementary Materials on the spot or within five working days to inform all the contents that need to be supplemented at one time. Fails to inform, since the date of receipt of the application materials is accepted;
(4) Where the application matters fall within the authority of the department, the application materials are complete and conform to the statutory form, or the applicant submits all the corrected application materials as required, it shall issue a notice of acceptance. The acceptance notice shall be stamped with the special seal for acceptance and indicate the date of acceptance.
Article 13 The (food) drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the entrusted (food) drug supervision and administration institutions of cities divided into districts shall conduct on-site verification of the enterprises to be applied for according to the acceptance standards of medical device trading enterprises, and review the application materials according to these Measures.
Fourteenth provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments shall make a decision on whether to issue the "medical device business license" within 30 working days from the date of acceptance. If it meets the requirements, it shall make a decision on granting the medical device business license, and issue the medical device business license to the applicant within 10 days from the date of making the decision. Do not meet the conditions, it shall notify the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
Article 15 When examining an applicant's application, the food and drug supervision and administration department shall announce the examination and approval process and results. Applicants and interested parties may submit written opinions, make statements and defend matters directly related to their major interests.
If the application for medical device business license directly involves the significant interests between the applicant and others, the (food) drug supervision and administration department shall inform the applicant and interested parties of the right to apply for a hearing according to law.
(Food) If the drug supervision and administration department considers that the business license of medical devices involves public interests, it shall make an announcement to the public and hold a hearing.
Sixteenth provinces, autonomous regions and municipalities directly under the central government (food) drug supervision and management departments shall publish the relevant information of the "medical device business license" that has been issued, and the public has the right to inquire.
Hope to adopt, thank you.
How to cancel the first-class medical device business license is similar to the cancellation procedure of the second-class and third-class medical device business licenses. Fill in the cancellation application form, carry the original business license, carry the ID card, provide the proof of whether it is being investigated, the list of remaining commodities and the instructions for handling. For details, please consult the window staff of the local drug supervision department.
How to apply for a medical device business license? You need to prepare the 1 business management file before applying; 2. Business premises (warehouse address); 3. Relevant personnel; 4. The business premises should be well planned; 5. Original personnel education or relevant supporting documents.
How big the specific business site requirements are depends on the requirements of your provincial food and drug administration or municipal service guide. Of course, if the category you apply for is high-level and the requirements for your personnel are relatively high, you should declare it according to the resources in your hand. Don't ask for everything at once. After applying, apply for change permission when conditions permit. If you don't know, I suggest you call the local food and drug administration for consultation. I hope the above answers are helpful to you.
Is there a filing certificate for the business license of Class III medical devices? Does the Medical Device Business License have a license? It belongs to the third kind of license. The medical device business registration certificate is in the case of food and drug supervision. Belongs to the second category of medical devices. Only business license, no license.
What are the medical device business licenses 68 10 and 680 1? A: Yes, the details are as follows:
680 1 basic surgical instruments
1: medical suture needle (without thread)
2; Basic surgical knife:
Surgical handle and blade, skin flap knife, wart peeling knife, The Lancet, shovel, razor, dander scraper, pick knife, front knife, pedicure knife, nail knife and scalpel.
3. Scissors for basic surgery
General surgical scissors, tissue scissors, comprehensive tissue scissors, suture scissors, plaster scissors, anatomical scissors, gauze bandage scissors, educational surgical scissors.
4. Basic surgical forceps
Common hemostatic forceps, small vessel hemostatic forceps, mosquito hemostatic forceps, tissue forceps, cemented carbide insert needle holder, common needle holder, sewing forceps, panel rolling forceps, bullet forceps, gauze stripping forceps, sponge forceps, towel forceps, catheter forceps and instrument forceps.
5. Basic surgical forceps
Small vascular forceps, non-invasive forceps, tissue forceps, plastic forceps, needle-holding forceps, health-care forceps (simple forceps), hair plucking forceps, towel forceps, dressing forceps, dissecting forceps, hemostatic forceps.
6. Needles and hooks for basic surgery
Aneurysm needle, probe, hair-pushing needle, hair-planting needle, needle-picking needle, straight needle for teaching, venous retractor, wound hook, flat retractor, double-ended retractor, panel retractor and dissecting hook.
7. Other instruments for basic surgery
Blade holder, anesthesia mask, anesthesia opener, lighting aspirator head, acne extractor, blackhead acne extruder, panel curette, panel sleeve scraper, panel scraping tester, panel inspection ruler, panel tissue drill, opener and cotton wool.
68 10 plastic surgery (orthopedic surgery) surgical instruments
1: knives and cones for orthopedic surgery.
Spinal canal shovel, spinal canal file, hand cone
Tap, pulp reamer, pressure screw reamer, cutter, osteotomy cutter, tibia cutter, plaster knife, tibia cutter, hip joint shaping concave-convex drill, drill bit, reamer, pistol hand bone drill.
2. Plastic surgery scissors
Double joint spinous process bone scissors, double joint biting bone scissors, bone scissors, knee ligament surgery scissors, plaster scissors, steel wire scissors.
3. Orthopedic forceps
Cervical vertebra rongeur, cervical vertebra double joint rongeur, scoliosis correction rongeur, nucleus pulposus rongeur, lamina rongeur, elbow flat spinous process rongeur, gun rongeur.
Knee polyp forceps, bone biting forceps, bone holding forceps, bone rotting forceps, reduction forceps, nail holding forceps, plate holding forceps, rod holding forceps, hook holding forceps, nail clamping forceps, spreading forceps, pressure forceps, gun-shaped sampling forceps, bone cutting forceps, steel plate bending forceps and wire cutters.
4. Saws, chisels and files for orthopedic surgery.
Circular saw, lumbar trapezoid osteotome, intervertebral disc operation circular saw, C-D laminectomy device, cervical vertebra exploration chisel, cervical vertebra right-angle osteotome, vertebral osteotome, anterior vertebral dissector.
Bow saw, finger saw, bone saw, small round chisel, T chisel, bone file, arc chisel, hip shaping chisel, gypsum saw, trapezoidal shovel, elbow humerus shaping chisel, medullary cavity file, spinal canal file, bone chisel, seat guide chisel.
5. Hooks and needles for orthopedic surgery
Unilateral lamina retractor, meniscus retractor, lower limb amputation retractor, bone hook, cervical vertebra retractor, anterior cervical deep suture needle, bone traction needle, compression screw guide needle.
6: Orthopedic (orthopedic) surgical scraper
Cervical curette, variable nerve stripper, curette, periosteum stripper (children)
7: Orthopedic surgery (orthopedic surgery) active instruments.
Pneumatic craniotomy device, battery self-stop skull drill, electric sternum saw, electric bone drill.
Electric gypsum scissors, electric gypsum saw
8: Other instruments used in orthopedic surgery
Limb extension frame, multifunctional unilateral external fixation bracket
Please adopt it. Thank you.
The address change of the Medical Device Business License requires on-site verification and acceptance.
I. Licensed items:
Changes to the Medical Device Business License
Second, the license basis:
Regulations on the Supervision and Administration of Medical Devices, Measures for the Supervision and Administration of Medical Device Business Enterprises, Measures for the Supervision and Administration of Disposable Sterile Medical Devices (Provisional), Detailed Rules for the Implementation of Qualification Recognition of Disposable Sterile Medical Device Business Enterprises (Provisional) and Detailed Rules for the Implementation of Local Measures for the Supervision and Administration of Medical Device Business Enterprises.
III. Scope of acceptance:
Change the enterprise name, registered address, business address, legal representative (person in charge), product range, etc.
Four. Application materials:
Application Form for Change of Local Medical Device Enterprises, and the following materials shall be declared at the same time:
(1) Documents approved by higher authorities or resolutions of the board of directors or corresponding documents required by investors, etc.
(2) Relevant application materials.
1. Change of enterprise name: a new business license or a copy of the notice of approval for change of enterprise name issued by the administrative department for industry and commerce.
2. Address change: title certificate or title certificate+copy of lease contract, geographical location map and floor plan.
3. Changes in product range: a) Newly established enterprises with increased product range; B) Where medical devices requiring special management are operated, the application shall be made in accordance with relevant regulations (for example, the operation of disposable sterile medical devices shall meet the requirements of the State Council Decree No.24 "Implementation Rules").
Verb (short for verb) program:
Acceptance by the provincial bureau-preliminary examination of materials-on-site examination (the licensing matters are entrusted to the municipal bureau for examination according to the accreditation standards)-the provincial bureau decides whether the licensing matters are allowed to be changed.
6. Processing time limit:
Thirty working days
Seven. Acceptance place:
Sheng USA Food and Drug Administration Administrative License Handling Office
What does the change of medical device business license include? The special change of medical device business license can be divided into two items: the change of licensing items and the change of registered items. Changes in licensing items of medical device business license include changes in quality management personnel, registered address, business scope and warehouse address (including adding or deleting warehouses). The change of registered items of medical device business license refers to the change of other items except the above items. Details can be found in official website of Ozda Medical Device Service Group.
The difference between medical device registration certificate and medical device business license A medical device registration certificate refers to the legal identity card of a product, and a medical device business license is a legal license to operate a product.
How to reissue the original three types of medical device business licenses and submit the application to the website of the Food and Drug Administration, and then prepare the materials and submit them to the Food and Drug Administration or the service window of the Food and Drug Administration? If the formalities are complete, just wait for the door-to-door acceptance. If the materials are not neat, people will not accept them and then come back to prepare them. Each food and drug administration requires different specific materials. Please consult the local food and drug administration. If you don't reissue it, just get a new one.