What are the requirements for a medical device license?
One, you need to have a company, the company's business scope of medical equipment business scope;
Two, ready to two quality person in charge of the need for medical equipment related graduates and engaged in the industry more than 3 years of work experience; ready to the actual business premises and warehouse, each place requirements are not the same, the Shanghai side of the usual requirements are: the use of business space area of 30 square meters, warehouse more than 15 square meters. square meters, warehouse greater than 15 square meters, some special product requirements are higher;
Three, prepare your plan to operate the product corresponding to the supplier's qualifications: product registration certificate, the company's business license, production and operation licenses, etc.;
Three, with this information to the local Drug Administration online application and submission;
Five, offline submission of information: download the application form submitted online and stamped. Online submission of the application form to download and stamped signature, with all the required information mentioned inside (are required to sign and stamp good), to the local Drug Administration or Administrative Service Center, such as Shanghai Baoshan side is to go to Songbin Road, No. 1 Baoshan Administrative Service Center to submit there.
Sixth, site visit: Because the three types of licenses are certain to visit the business premises and warehouses, to do a good job before visiting the site layout and waiting for the Medical Devices Section personnel to visit, visit will be further approved;
seven, the site is no problem, is waiting for the leadership approval, and then notify you to collect the license.
Specific information is based on local policy. Note: a class of medical devices are not required to apply for a license, class II also only need to do a filing, and class III medical devices only need to apply for a license.