Medical devices are divided into three categories, one of which works directly without a license.
To apply for a medical device business license, the following conditions shall be met at the same time:
(1) Having a quality management organization or full-time quality management personnel suitable for the business scale and scope. Quality management personnel should have relevant professional qualifications or titles recognized by the state;
(2) Having a relatively independent business place suitable for its business scale and business scope;
(3) Having storage conditions suitable for the business scale and business scope, including storage facilities and equipment that meet the requirements of medical device product characteristics;
(four) establish and improve the product quality management system, including procurement, purchase acceptance, warehousing, outbound audit, quality tracking system and adverse event reporting system;
(5) It shall have the technical training and after-sales service capabilities suitable for the medical device products it deals in, or agree to provide technical support by a third party.
Medical device business license procedures:
1. To start a second or third class medical device business enterprise, an application shall be submitted to the food and drug administration branch where the enterprise is located, and the following materials shall be submitted:
(1) Application Form for Shanghai Medical Device Business License;
(2) Registration Form of Application Materials for Medical Device Business Enterprise License;
(3) A copy of the enterprise name pre-approval certificate or business license issued by the administrative department for industry and commerce (original inspection);
(4) The ID card, certificate of education or professional title and a copy of the resume of the person in charge of quality management of the proposed enterprise;
(5) A copy of the ID card, education or professional title certificate of the quality management personnel of the enterprise to be established;
(six) the organization and functions of the enterprise to be established or the functions of full-time quality management personnel;
(7) A copy of the geographical location map, floor plan (indicating the area), house property right certificate or lease agreement (attached with the leased house property right certificate, the same below) of the registered place and warehouse of the proposed enterprise;
(8) Product quality management system documents and storage facilities and equipment catalogue of the proposed enterprise.
The accepting branch shall make a decision according to Item (2) of Article 12 of the Measures for the Administration of Medical Device Business License.
After accepting the application materials, the district (county) branch of the US Food and Drug Administration shall complete the data review and on-site review within 30 working days from the date of acceptance, and make a decision on whether to issue the Medical Device Business License. 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 working 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.
2. Enterprises applying for the business scope of "all kinds of medical devices" shall be examined and approved by the US Food and Drug Administration in conjunction with the food and drug supervision branch where the enterprise is located, and the branch shall be responsible for daily supervision.
3. Where an enterprise is divided, merged or moved across the original jurisdiction, it shall re-apply for the Medical Device Business License in accordance with regulations.
4. Legal liability:
1. If the applicant conceals relevant information or provides false materials to apply for the Medical Device Business License, the district (county) branch of the US Food and Drug Administration shall reject the application or refuse to issue the Medical Device Business License and give a warning. The applicant shall not apply for the Medical Device Business License again within 1 year.
2. If the applicant obtains the Medical Device Business License by cheating, bribery or other improper means, the district (county) branch of the US Food and Drug Administration shall revoke its Medical Device Business License, give a warning and impose a fine of 6,543,800 yuan to 20,000 yuan. The applicant shall not apply for a medical device business license again within 3 years.
Treatment process
◆ Registration fee
1, industrial and commercial name retrieval fee;
2. Industrial and commercial registration fee;
3. Capital verification fee;
4. Organization code fee;
5. Tax registration fee;
6. Carving fee.
Taking the registered capital of 654.38 million yuan as an example, the upper limit of the whole set of industrial and commercial expenses is1.5 million yuan, and the medical device license fee is extra.
◆ Registration time
20-22 working days after the name is approved and the capital verification report is issued.
The general taxpayer qualification will be increased by 7- 10 working days.
Where pre-approval is involved, the approval of relevant departments shall prevail, and the registration time shall be postponed accordingly.
◆ Registration process
1, industrial and commercial name pre-approved;
2. Sign the industrial and commercial registration materials;
3. Open a special account for capital verification, go through capital verification procedures and issue a capital verification report;
Step 4 apply for a license
5. Handling industrial and commercial registration;
6. Engraving official seals and other required seals;
7. Organization code registration;
8. Handling tax registration;
9. Open a basic bank account (tax account)
10, go to the tax department to apply for general tax qualification (our garden will apply for it).
1 1. Go to the tax department for tax verification and purchase invoices.
tax rate
◆ Collection method
Audit collection
◆ Tax rate
Main taxes involved by general taxpayer enterprises: value-added tax (17%)
Enterprise income tax, audit collection (25%)
tax preference
◆ Tax policy
Enterprises registered in our economic park can enjoy a large part of financial support:
1) Business tax enjoys 50-80% of local fiscal revenue.
2) The enterprise income tax can enjoy up to 60-90% of the local fiscal revenue.
3) The maximum value-added tax is 50-80% of the local fiscal revenue.
4) Implement the policy of "one thing, one discussion" for large taxpayers.