Medical Device Product Manufacturing Standard for Precision Processing of Medical Parts
Everyone knows that medical device products are different from other automation or other industry equipment. The state has strict standards for this. Shenzhen Hongweisheng Precision Technology, which is dedicated to the precision processing of medical parts, has all the medical device product manufacturing standards for you. Which, let's find out together.
I. Examination and Approval Authority: Enterprises operating Class II or III medical devices shall report to the Provincial Drug Administration for review and approval, and issue the Medical Device Operating Enterprise License.
1. Provincial enterprises (registered by the Provincial Administration for Industry and Commerce) shall be directly accepted by the Provincial Drug Administration; 2. Other enterprises and units shall be accepted by the drug regulatory authorities of each city and undergo initial inspection and acceptance. If they are qualified, they shall write a written acceptance opinion and sign it in the examination form. After the preliminary review opinions are submitted to the Provincial Product Supervision Bureau for approval.
2. Application materials:
1. One application report;
2. Fill out the application form of "Medical Device Operating Enterprise License" in triplicate (the photocopy is invalid);
3. One copy of the company's (company) articles of association and the latest capital verification report (providing the company's balance sheet and profit and loss statement for renewal);
4. A self-examination summary of the enterprise (compare with the "Implementation Rules for the Qualification Recognition of Medical Device Operating Enterprises in Guangdong Province" and the requirements of "Guangdong Provincial Standards for Inspection, Exchange and Acceptance");
5. List of technical and maintenance personnel, one copy of their graduation certificate and professional title certificate (with official seal of the unit);
6. One copy of the property right certificate or lease agreement and floor plan of the operation and storage place;
7. A detailed written preliminary examination and acceptance report of the Municipal Drug Administration (except for provincial enterprises);
8. One copy of the certificate of pre-registration for business registration of the enterprise name or the copy of the Legal Person Business License;
9. Various management rules and regulations. a. system of quality responsibility and veto; b. system for storage acceptance, custody, and warehouse review; c. quality analysis and feedback system; d. validity period management system; e. store sales quality management system; f. special and imported medical treatment Device management system; g. After-sales service (installation, use of technical training, maintenance, repair, etc.) system; h. Implantation and special medical device quality tracking and adverse reaction reporting system; i. Returns, unqualified, expired or obsolete medical Device handling reporting system; j. Health management system;
10. Self-assurance statement on the authenticity of the information provided.
Third, the approval process
1. The Provincial Drug Administration can only accept the application if the application materials are complete and meet the requirements of the approval procedure. The handler shall organize relevant personnel or entrust the municipal drug regulatory department to conduct on-site acceptance within 15 working days from the date of acceptance in accordance with the “Implementation Rules for the Qualification Recognition of Medical Device Operating Enterprises in Guangdong Province”. The acceptance content includes: office, business, storage, maintenance sites, testing, maintenance equipment and installation and maintenance records, quality system implementation, technical staff on-the-job status, operating varieties and collection and preservation of medical devices, regulations, rules and quality standards of the managed varieties, Relevant information such as medical device product registration certificate.
2. Those who pass the on-site inspection and acceptance shall fill in the medical device approval form within 10 working days, put forward the preliminary review opinions, and report to the department and bureau leaders for approval in accordance with the procedures.
Fourth, the application requirements
1. The content of the application report shall include: the economic nature of the enterprise, the brief introduction of the main person in charge, the establishment of the department, the establishment of the branch, the main business area and the main sales target, the main business varieties, specifications, storage location and surrounding environment.
2. List of technical and maintenance personnel: refers to technical, medical, pharmaceutical, and engineering technical personnel, and requires the name, gender, age, last graduated school, education, major, technical title, company title, and ID card number.
3. Floor plan of the operation and storage place: The operation and storage place shall indicate the length and width (meters), the position of the business layout and the location of the shelves, the location of the fire fighting equipment, and the five-proof facilities.
4. All application materials must be printed on A4 paper, and affixed with the official seal of the enterprise, unit or superior in charge, a copy of the business name pre-registration certificate of the company name or a copy of the legal person's business license, technical and maintenance personnel graduation certificates, professional title certificates, etc. The unit shall indicate the words "the copy is consistent with the original" on the photocopy, stamp it with the official seal, and bind it into a booklet in order.
V. Other matters
Enterprises and units should report in accordance with the above-mentioned approval procedures and requirements, and it is strictly forbidden to donate property to the handling personnel. If you request or accept property, please report to the Supervision Office of the Provincial Drug Administration.