If you want to produce you need to apply for a medical device production license (including the scope of business)
If you want to operate you can apply for a medical device license on it
Application conditions:
Apply for a Medical Device Business License should have the following conditions at the same time:
(A) with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and the reporting system of adverse events;
(v) should have the appropriate technical training and after-sales service capacity with its operation of medical device products, or agreed to provide technical support by a third party.
Procedures:
1, the opening of the second and third class of medical equipment business enterprises, should apply to the operating location of the Food and Drug Administration sub-bureau and submit the following information:
(1) "Medical Device Business License Application Form";
(2) "Medical Device Business License Application Materials Registration Form";
(3) Pre-approval of the business name issued by the administrative department for industry and commerce or a copy of the "business license" (verification of the original);
(4) the proposed enterprise quality management person in charge of the identity card, a copy of the certificate of academic qualifications or titles and personal resume;
(5) the proposed enterprise quality management personnel's identity card, a copy of academic qualifications or certificates of professional titles;
(6) Proposed business organization and functions or full-time quality management personnel functions;
(7) proposed business registration, warehouse location map, floor plan (indicating the area), proof of property rights or lease agreement (with proof of property rights of the leased premises, the same below) a copy;
(8) proposed business product quality management system, documentation and storage facilities, equipment directory.
The receiving branch shall be in accordance with the "Medical Device Business License Management Measures" Article 12, paragraph 2 of the provisions of the processing decision.
District (county) Food and Drug Administration Branch accepts the application information, shall be accepted within 30 working days from the date of data review and on-site review, and make a decision on whether to issue a "medical device business license". Considered to meet the requirements, should be made to grant the issuance of "medical device business license" decision, and within 10 working days from the date of decision to the applicant to issue "medical device business license". Considered does not meet the requirements, shall notify the applicant in writing, and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation in accordance with the law.
2, apply for the business scope of "all types of medical devices" enterprises, by the Municipal Food and Drug Administration in conjunction with the county where the enterprise business food and drug regulatory branch for approval, day-to-day supervision by the branch is responsible for.
3, enterprise separation, merger or migration across the original jurisdiction, should be in accordance with the provisions of the re-application of "medical device business license.