Business Permit of Enterprise of Medical Device
Conditions Of Obtaining Administrative Permit
The legal representative of an enterprise, the principal of an enterprise, and the personnel of quality control shall avoid the case of Article 40 specified by Regulation on Supervision and Administration of Medical Device
The enterprise shall be provided with organization of quality control or special personnel of quality control suitable for business scale and scope; the personnel of quality control shall be equipped with relevant specialty, background education, or technical title which are identified by the Chinese government; the personnel of quality control shall be the professional technician whose qualification has been approved according to the laws; the personnel of quality control shall work in the specified position and shall not work part-time in the other companies.
The enterprise shall be provided with a relatively independent place in which business is carried out and the place shall be in consistence with business scale and scope.
The enterprise shall be provided with storage conditions (storage equipment and facilities) in agreement with business scale and scope.
The enterprise shall be capable of offering technical training and after-sales services about its products.
In light of relevant regulations stipulated by the national and the local authorities, necessary system of quality control shall be established and improved and then shall be strictly implemented.
The enterprise shall collect and save national standard and industrial standard related to medical devices, including laws, regulations, rules, and specific ordinances with respect to supervising and administering medical devices.
List Of Materials Submitted By The Applicant
Form of Applying for Business Permit of Enterprise of Medical Device, Business Permit of Enterprise of Medical Device.
Notice of Pre-qualification of Name of Enterprise or Business License of Industry and Commerce issued by the administration of industry and commerce.
A Report of Application.
Certificate of business site and warehouse site, including housing property certificate or leasing agreement and photocopy of certificate of the housing property of leaser.
Plan of business site and warehouse layout.
The photocopies of ID, education background certificate, job title certificate, and CV of a legal person, an enterprise principal, and personnel of quality control.
A list of technician, including the photocopy of education background and certificate of job title.
A list of document of specification of quality control of business.
The enterprise has already installed a system of information management to purchase, sell, and store the products; print out the first page of system of information management.
A list of facilities and equipments of warehouse storage.
The in-service personnel of quality control shall make a self-guarantee declaration about his service in the relevant position and a self-guarantee declaration about the truthfulness of documentation of application, including the commitment of undertaking legal liability made by the enterprise with regard to any false information among the application materials and the contents of application materials.
When submitting the application materials of enterprise, if a person in charge of such application is not the legal representative or the principal of enterprise, then the enterprise shall submit A Letter of Authorization (LOA).
A letter of confirmation of applying for Business Permit of Enterprise of Medical Device.
The Request For Application Materials
Form of Applying for Business Permit of Enterprise of Medical Device submitted by the enterprise shall be signed by the legal representative or stamped with official chop of enterprise.
All the items filled on Form of Applying for Business Permit of Enterprise of Medical Device shall be full, complete, and accurate, and the contents filled shall meet the following requirements.
The “name of enterprise” and “site of registration” shall be identical with those stipulated by Business License of Industry and Commerce or Notice of Pre-qualification of Name of Enterprise.
The proposed business scope shall be filled according to the first ranking catalogue set out by Contents of Categorization of Medical Device which has been issued and printed by State Food and Drug Administration (SFDA).
The “site of registration” and “site of warehouse” shall be filled in details, such as the specific house number, floor, and room number.
The ID certificate, certificate of education background, certificate of job title, and a letter of appointment of the legal representative shall be valid.
The photocopies of Notice of Prequalification of Name of Enterprise or Business License of Industry and Commerce issued by the administration of industry and commerce shall be in line with the original; the photocopies are confirmed to be kept on the administration side, while the original will be returned.
The certificate of housing property and the certificate of the leased house (the leaser must offer a certificate of property ownership) shall be valid.
The CV, certificate of education background, or certificate of job title of enterprise principal and quality administrator shall be valid.
The enterprise shall, in the light of its own reality, set up archives or forms of quality management of medical device.
The self-guarantee declaration of truthfulness of application materials shall be signed by the legal representative and stamped by official chop of enterprise; in case the official chop is unavailable, then it must be signed or stamped personally by the legal representative.
If any photocopy of application materials is required, the applicant (company) must mark “this photocopy is in conformity with the original” or leave text description on the photocopy that is dated and stamped with official chop of company; the application submitted by an individual shall be signed or stamped.
The application materials shall be full, complete, clear, signed, and stamped with official chop one by one. All the application forms must be typed and filled through computer, and printed out by A4 paper; A4 paper is also used to photocopies; they must be bound up according to sequence of contents of application materials.