The main body of the declaration should meet: 1. The main body of the declaration is registered in Qingdao, with independent legal personality of the biomedical enterprises or organizations; 2. The policy effective period to obtain the clinical record of Class II and Class III medical devices voucher, the "medical device registration certificate". Enterprise declaration materials should also include: 1. Qingdao biomedical industry subsidy project application form; 2. "Medical Device Clinical Filing Form", "Medical Device Registration Certificate"; 3. Clinical trial research related materials; 4. Financial audit report issued by the accounting firm; 5. R & D costs invested in materials, including expenditure details, contracts, invoices and so on.
In addition, the clinical filing of Class II and Class III medical devices is verified by the Municipal Bureau of Industry and Information Technology together with the regulatory authorities.