Medical Device License" is the operation of the third class of medical devices enterprise "identity card", many companies in the qualification, like to use time and money to measure the investment to do the license, this approach you think is correct?
From the point of view of enterprise management, the investment of money and time is an important factor to complete the work. Operation of Class III medical devices most of the enterprise work plan is written:
1, the lease meets the requirements of the business premises and warehouse, business premises ≥ 100 square meters of floor space, warehouse floor space ≥ 60 square meters, cold storage volume ≥ 20 cubic meters. 30 days to complete the lease of a non-marginal room as the standard for calculating the lease expenditures of about 6-10 million / year.
2, for business license, bank account opening and other work, completed within 15 days.
3, business premises office facilities procurement, completed within 7 days, procurement expenditure of about 2-4 million yuan. Treasury renovation, cold storage construction, facilities and equipment, management software, completed within 30 days, spending about 6-8 million yuan.
4, the recruitment of quality management personnel 2-3, 15 days must be on duty, salary, benefits, social security and other expenditures of about 20-30 million yuan / year.
5, to complete the preparation of business quality management system documents (including reporting information), within 20 days.
6, submit the declaration information to the on-site audit to ensure a one-time pass, completed within 20 days.