Application conditions
Engaged in the third class of medical equipment business (retail) units can apply for "Medical Device Business License" Declare the approval of the department before the need to other departments for approval: To obtain the "Business License" ("Business License" on the "Organization Code Certificate No." is not specified) Enterprises should also obtain the "Organization Code Certificate"). Matters related to the approval of the necessary conditions: medical device business enterprises to meet the quality management standard for the operation of medical devices and medical device business quality management standard on-site inspection of the guiding principles of the requirements.
Materials to be prepared for application
1, "Sample Application Form for Medical Device Business License"
2, copy of "Business License"
3, copy of "Organization Code Certificate"
4, legal representative of the enterprise, the person in charge of the enterprise, a copy of identity, education, title certificates
5, quality Management personnel of identity cards, personal history, copies of academic certificates and certificates of technical titles, I signed the on-the-job not part-time, labor contract
6, to operate corneal contact lenses (excluding corneal reshaping contact lenses) and its care of the liquid medical device retailers, to provide copies of the identity cards of professional and technical personnel, with a copy of the certificate of education attached to the academic qualifications, with a copy of the certificate of professional title with a copy of the relevant qualifications. Copies and copies of relevant qualification certificates; personnel working in the state with employment access positions are required to pass vocational skills assessment and obtain a valid vocational qualification certificate before taking up their duties.
7, the company's personnel list (indicating name, gender, age, education, position, title, identity card number)
8, "Medical Device Business Quality Management Standard Self-inspection Form" text example
9, the organization and departmental setup description
10, the scope of operation, business mode description
11, business facilities, equipment directory
12, to be used to improve the quality of medical devices, medical devices, medical devices, medical devices, medical devices, medical devices and medical equipment. p>
12, the proposed business premises, warehouse address of the lease agreement, a copy of the certificate of property rights, business premises and warehouse address plan (indicating the area) and geographic location map
13, business quality management system, work procedures and other documents directory
14, the basic information on the computer information management system and the functional description, accompanied by purchase invoices
15, the operator's authorization certificate
16, the copies mentioned in the above materials need to be submitted for verification of the original
17, the proposed enterprise to administrative licensing (administrative confirmation) of the authenticity of the application materials to ensure that the statement; require all the declaration of information to prepare the page number, and in the authenticity of the statement of assurance of the range of pages indicated in the sample table
Application process
(a) the Application information for review, check whether the application information is complete and complete, in line with the statutory form:
1, the application matters fall within its terms of reference, the application information is complete, in line with the statutory form, the application should be accepted;
2, the application information is incomplete or does not comply with the statutory form, the application should be informed of the applicant needs to make corrections to all the contents of the application on the spot or within five working days at a time,. Late notification, from the date of receipt of the application information shall be accepted; 3, the application information can be corrected on the spot errors, the applicant should be allowed to correct on the spot;
4, the application does not fall within the purview of the department, should be made immediately inadmissible decisions, and inform the applicant to the relevant administrative departments.
(B) the approval department from the date of acceptance within 20 working days to complete the data review and on-site review, and make a decision on whether to issue a "medical device license". Medical device business (retail) enterprises that meet the requirements of the Drug Administration website or office space to the community to publicize the relevant content, within 5 days from the date of publication, no complaints, reports or other objections received within 10 days from the date of decision to the applicant to issue a "medical device license".
Failure to meet the requirements of the medical device business (retail) enterprises, notify the applicant in writing, and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration according to law or bring an administrative lawsuit.
Important Note:
1, engaged in Class III medical device business (retail) activities, should first apply for a "business license" (Business License) (Business License does not specify the "Organization Code Certificate No." of the business should also obtain the "Organization Code Certificate"), and then apply for the "Medical Device Business License".
2, the business license must be of an enterprise nature, individual businessmen can not apply for a "medical equipment business license".
3, the new establishment of independent business premises, should apply for a separate medical device license.
4, may be eligible for retail sales of Class III management of medical devices are mainly distributed in the following sub-categories: 6815 injection puncture instruments (single-use sterile syringes and injection needles), 6822 medical optical instruments (soft corneal contact lenses and nursing fluids), 6825 medical high-frequency instrumentation and equipment (high-frequency physical therapy instrument), 6840 in vitro diagnostic reagents (personal use molecular) Diagnostic reagents), 6854 operating room, emergency room, diagnostic and treatment room equipment and appliances (insulin pumps, hormone pumps, etc.), 6866 personal consumption of medical polymer materials and products (condoms with functional additives, etc.).