For medical equipment three types of business license process:
1, for different medical equipment three types of business projects need to prepare 60 square meters 100 meters office, 40 square meters 80 square meters warehouse 2, provide a copy of the real estate license, the rental contract 3, the quality of the administrator and the sales and marketing inventory software
4, submit the preliminary examination online, offline delivery of materials 5, if it is the operation of cold chain Also need to provide more than 20 square feet of cold storage, and a competent inspector
Can guide the whole process free of charge, provide quality administrator, third-party warehouse, can also be hosted for professional processing.
Medical device license address fee:Pay 15,000 years. If there is a high tax, you can apply for a reduction. One year medical device business license, the cost of 15,000. medical device company registration fee:Company registration fee of 1,000 yuan.
List of main production equipment and inspection instruments (original). Quality manual and program documents (original). Process flow chart (original). Self-inspection form of the production enterprise (original). Other supporting information. Note: Others are prepared according to the specific regulations of the local Drug Administration.
For medical device business license, what materials do companies need to submit? Since October 1, 2014, the approval and licensing authority of the medical device business license has been delegated to the municipal * regulatory departments in the districts. So each region has different requirements for submitting materials according to the actual situation. But the regulatory requirements are the same, door-to-door inspection will be in accordance with the "medical device business quality management standard" on-site audit.
The third class of medical devices business enterprise quality should have medical device related professional (related professional refers to medical devices, biomedical engineering, machinery, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, testing, management and other professions, the same below) college degree or intermediate or above professional and technical title, and should have more than 3 years of medical device business quality management experience. Management experience.
Engaged in in vitro diagnostic reagents quality management personnel, there should be a supervisor for the inspector, or with a university degree or higher in testing related disciplines and engaged in testing related work for more than 3 years of work experience. In vitro diagnostic reagents acceptance and after-sales service personnel, should have a secondary school education in laboratory-related disciplines or with a junior or above the professional and technical title of inspector.
Engaged in implantable and interventional medical devices business personnel should be equipped with medical related college degree or above, and through the production enterprises or suppliers of training personnel.
On the product registration requirements, on the inspection personnel information sheet, in view of the inspection personnel, professional, engaged in the position of the number of years of experience on the quality of self-inspection report is critical to better standardize the work of self-inspection, the requirement to submit self-inspection of the registration declaration information inspection personnel information sheet to help the regulatory authorities to understand the situation of the inspection of the enterprise's staffing.