Medical device company registration process? Who can help me?

Application conditions for medical device business license: medical devices are divided into three categories. Class I does not need to apply for a license, and shall meet the following conditions: (1) Having a quality management institution or full-time quality management personnel suitable for the scale and scope of business. 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. Procedures for medical device business license: 1. To establish the second and third types of medical device business enterprises, an application shall be submitted to the food and drug administration branch where the business 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. Handling process ◆ Registration fee 1, industrial and commercial name search 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 6,543,800 yuan as an example, the upper limit of the whole set of industrial and commercial expenses is 654.38+ 0.500 yuan, and the medical device license fee is extra. ◆ It will take 20-22 working days after the registration time and name are approved, and the capital contribution is completed and the capital verification report is issued. The general taxpayer qualification will be increased by 7- 10 working days. If pre-approval is involved, the registration time will be postponed accordingly. ◆ Registration process 1, and pre-approval of industrial and commercial names; 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; 4, apply for a license 5, apply for 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, apply to the tax authorities for general tax qualification (our application) 1 1, go to the tax authorities for tax verification and purchase the invoice tax rate ◆ Review the collection method ◆ Tax rate The main taxes involved by ordinary taxpayers: value-added tax (17%) enterprise income tax. Tax policy ◆ Enterprises registered in our economic park can enjoy a large part of financial support: 1) Business tax can enjoy 50-80% of local fiscal revenue; 2) Enterprise income tax can enjoy 60-90% of local fiscal revenue; 3) VAT can enjoy 50-80% of local fiscal revenue; 4) Implement "one case, one discussion" for large taxpayers.