Handling all kinds of Business License of Medical Devices is one of the main business of Shanghai Wecome Business Consulting Company. Over the past 10 years, Business License of Medical Devices has been handled in almost all areas of Shanghai, with more than 1, 000 successful customers. From the ordinary class II/III to the most complicated IVD reagents (one third in Shanghai has been handled by us), the number we handled every month is the first in Shanghai.
Our customers include as follows:
Advanced Bionics LLC
Bank of Communications
The following is the related information about the establishment of class-II/class-III medical device companies in Shanghai:
I. Process and time
1. Early consultation, in order to understand the products and customer situation;
2. Signing of the contract; company name query (5 working days);
3. Approval documents for the registration of a wholly foreign-funded enterprise (10 working days);
4. Industrial and commercial business license for the registration of a wholly foreign-funded enterprise (10 working days);
5. Providing the required materials for medical devices (10-15 working days);
6. We will personally arrange the site and train the customer’s staff (1 working day);
7. Materials are formally submitted to the Food and Drug Administration for registration (30 working days).
7.1 The Food and Drug Administration will interview with the customer within three weeks, we will inform the customer of specific time;
7.2 Within two weeks after the interview, the customer will obtain the business license of class-II/class-III medical devices;
8. Changing the business license to add class-III business scope (15 working days);
9. Handling the rest of other certificates (20 working days);
10. Payment of the balance, handover of certificates, all over.
The required time is roughly 3.5 months, including the company registration for 1.5 months, license handling for 1.5 months, and addition of class-III business scope for 1 month.
II. Content of customer cooperation required
The customer should appoint three people to interview with the Food and Drug Administration, two of them are required to study related medical major (machinery, electronics, biology, chemical industry, computer, clinical medicine and pharmacy), with college degree or above.
III. Registered capital
It is recommended that the registration capital of a foreign-funded medical device company should not be less than RMB 500,000, which is easier to approve.
The total price of general medical devices is about USD 5,000-7,000, and the price of special products will be higher. Please send mail to [email protected] for specific price.
V. Annual inspection and follow-up maintenance
Our company will provide comprehensive maintenance services, including the accounting, declaration of tax, receipt of invoices, annual inspection, etc., and maintain the relationship with the Administration of Industry and Commerce, Tax Bureau, Food and Drug Administration on behalf of customers. Customers only need to come to Shanghai for invoicing at the time of establishment, and the rest can be handled by us.
Please contact us for the price and content of specific maintenance (contact: [email protected])
For more information， please contact [email protected]