As we all know, medical device products are different from other automation or industry equipment, and the country has strict standards for control. Shenzhen EMAR Precision Technology, which is committed to precision machining of medical parts, shares with you the manufacturing standards for medical device products. Let's take a look together.

1 , Authoritia approbata: Enterprises engaged in the operation of Class II and III medical devices shall report to the Provincial Drug Administration for review and approval, and be issued a "Medical Device Operation Enterprise License".

1. Provincial owned companies (registered with the Provincial Administration for Industry and Commerce) are directly accepted by the Provincial Drug Administration; 2. Other enterprises and units are accepted and preliminarily inspected by the drug regulatory departments of each city. If they pass the inspection, a written acception opinion is written and the preliminary inspection opinion is signed in the review form before being submitted to the provincial quality supervision bureau for approval.

2,Declaration materials:

1. Una reporta aplicationis;

2. implete tres copies of the application form for the Medical Device Business License (photocopies are invalid);

3. One copy of the company's articles of association and the latest capital verification report (for certificate replacement, provide the company's balance sheet and income statement);

4. One copy of the enterprise self inspection summary (in accordance with the requirements of the "Implementation Rules for Qualification Recognition of Medical Device Operating Enterprises in Guangdong Province" and the "Guangdong Province Nuclear, Exchange, and Acceptance Standards");

5. Lista personālum technical and maintenance, along with one copy of their graduation certificate and one copy of their professional title certificate (stamped with the official seal of the unit);

6. Una copy of property ownership certificate or lease agreement and floor plan for the operation and storage premises;

7. Una detalja scripta priora revisione et acceptatio report ab Administratione Municipal Drugs (excluding provincial enterprises);

8. Una copy of the business name pre registration certificate or the copy of the "Corporate Business License";

9. Various management rules and regulations. a. Responsibilitatem qualitatis et systemam veto potentiae; b. Acceptatio depositoris, deposita et systema revisionis foris; c. Analisi qualitatis et systema feedback; d. System administracionis validitatis; e. Sistema administracionis qualitatis venditatis venditatibus venditatibus; f. Systema administracionis medicorum speciosorum et importorum medicorum; g. post servum venditatis (installation, technical training, maintenance, repair, etc.) systemam; h. Qualitatem tractionem et adversam reactionem reportationis systemam implantatis et specialibus medicorum; i. Return, non conformation, expiration date or elimination of medical devices processing report system; j. Systemam administracionis sanitatem;

10. A self-assurance statement regarding the authenticity of the information provided.

3,

1. Praecepta registra droga provincialis solmente potest accept are, si materia aplicationis completa sunt et conformentur opus procedentis approbationis. Operator organizabit personnel relevantem aut dimittet departamentum regulatoris medicorum municipalis ut acceptum sit in loco post 15 dies a die acceptationis iuxta regulas Implementationis ad Recognitionem Qualificationis Periodium Operatorum Medicinum in provincia Guangdong. The acceptance contents include: office, business, warehousing, and maintenance sites, testing and maintenance equipment and installation and maintenance records, quality system implementation, technical personnel on duty situation, regulations and rules on the types of medical devices operated and the collection and preservation of medical devices, quality standards for the types of medical devices operated, medical device product registration certificates and other relevant materials.

2. Qui accipiunt acceptionem regionis implebunt formam approbationis medicorum usque ad decem dies operantium, opiniones initiae revisionis provident, et ad principes regionis et regionis ad approbationem iuxta proceduras.

4,Requirements for Declaration Materials

1. The application report should include: the economic nature of the enterprise, introduction of the main person in charge, department setting, branch setting, main business areas and main sales targets, main business varieties, specifications, storage facilities and surrounding environment.

2. List of technical and maintenance personnel: it refers to technical personnel in science and engineering, medicine, pharmacy and engineering. It is required to list the name, gender, age, final school of graduation, education background, major, technical title, company position and ID card number.

3. Plan of operating and storage facilities: The operating and storage facilities should indicate their length, width (meters), layout, shelf placement, location of fire equipment, and five prevention facilities.

4. Omnes materiae aplicationis in litteras A4 impressi sunt et in signo oficial firmae, universis, aut supervisoris universis. Nomen firmae cum copie certificati registrationis negotiationis aut licentiae registrationis legis, aut copies certificati diplomationis technicis et maintenantis, certificati profesionalis tituli, etc. Unitatis aplicationis ad copies quos:; Copia oriunda est; et clamabuntur verba signo officio et ligabitur in libro ordine

5,Other matters

Enterprises and units should follow the above approval procedures and requirements for declaration. It is strictly prohibited to give gifts of property to the handling personnel. If anyone requests or accepts property, please report to the Supervision Office of the Provincial Drug Administration.