How Do I Get Medical Coding Certification?

Medical device registration refers to the process of systematically evaluating the safety and effectiveness of medical devices intended for sale and use in accordance with legal procedures to determine whether to agree to their sale and use. It is divided into domestic medical device registration and overseas medical device registration. Regardless of whether the overseas medical devices are of the first, second, or third type, they must go to the Beijing State Food and Drug Administration: the first and second medical devices in the country are in the local province Or the Municipal Food and Drug Administration, the three types of applications to the State Food and Drug Administration. The medical device registration certificate refers to the legal identity card of medical machinery products. ^[1]

Medical Device Registration Certificate

Medical device registration refers to the safety and effectiveness of medical devices intended for sale and use in accordance with legal procedures.

Medical Device Registration Certificate Number

The medical device registration number consists of six parts, and the basic arrangement is: X (X) 1 Food and Drug Supervision (X2) Character XXXX3 No. X4XX5XXXX6.

X1 is the abbreviation for the location of the registration approval department. The third category of domestic medical devices, overseas medical devices, and medical devices in Taiwan, Hong Kong, and Macau are "national" characters. The second category of medical devices in China is the abbreviation of the province, autonomous region, or municipality where the registration approval department is located. The first category of medical devices in China is the abbreviation of the province, autonomous region, and municipality where the registration approval department is located, plus the abbreviation of the municipal administrative region where the district is located. This is the abbreviation of XX1 for a municipal administrative region without a corresponding district. X2 is the registration form (quasi, advance, permit). The word "quasi" applies to domestic medical devices, the word "jin" applies to overseas medical devices, and the word "xu" applies to medical devices in Taiwan, Hong Kong, and Macau. XXXX3 is the approval year, X4 is the product management category, and XX5 is the product variety code. XXXX6 is the registration serial number.

On October 1, 2014, the new version of the "Administrative Measures for the Registration of Medical Devices" came into effect, and the "Administrative Measures for the Registration of Medical Devices" (originally issued by the State Food and Drug Administration Order No. 16) promulgated on August 9, 2004 was abolished simultaneously. The new version of the "Administrative Measures for the Registration of Medical Devices" has re-developed the method of compiling certificate numbers:

The registration number is arranged as follows:

× 1 machine note × 2 ×××× 3 × 4 ×× 5 ×××× 6. among them:

× 1 is the abbreviation of the location of the registration approval department:

Domestic third-class medical devices, imported second-class and third-class medical devices are "national";

The second category of medical devices in China is the abbreviation of the province, autonomous region and municipality where the registration approval department is located;

× 2 is the registration form:

The word "quasi" applies to domestic medical devices;

The word "jin" applies to imported medical devices;

"Xu" is applicable to medical devices in Hong Kong, Macau and Taiwan;

×××× 3 is the year of first registration;

× 4 is the product management category;

×× 5 is the product classification code;

×××× 6 is the serial number for the first registration.

If registration is continued, the numbers of ×××× 3 and ×××× 6 remain unchanged. Product management category adjustments shall be renumbered.

The first type of medical device filing certificate number is arranged as follows:

× 1 machine prepared ×××× 2 ×××× 3.

among them:

× 1 is the abbreviation of the location of the filing department:

Imported first-class medical devices are "national";

The first category of medical devices in the country is the abbreviation of the province, autonomous region, and municipality where the filing department is located plus the abbreviation of the municipal administrative region where the district is located.

×××× 2 is the filing year;

×××× 3 is the registration serial number. ^[4]

Medical device registration certificate application materials

What materials or information should be prepared for the medical device registration certificate?

1. First go to your city Food and Drug Administration to get the application form and electronic text (you can also download it from the website). Then prepare according to the following materials.

Application materials (1) Application Form for "Medical Device Manufacturing Enterprise License" (Start-up);

(2) Basic information and qualifications of legal representative and person in charge of the enterprise, including identity certificate, academic certificate, professional title certificate, photocopy of appointment documents, job resume;

(3) The original and photocopy of the enterprise name approval notice or business license issued by the administrative department for industry and commerce;

(4) Production site certification documents, including a copy of the real estate certificate or lease agreement and the leased party's real estate certificate, the general plan of the factory area, and the layout of the main production workshop. Workshops with cleanliness requirements shall indicate the function room and the direction of people and logistics;

(5) Resume of the person in charge of the production, technology and quality departments of the enterprise, copies of academic qualifications and professional title certificates; copies of relevant professional and technical personnel, skilled worker registration forms, certificates, and indicating their departments and positions; A table of the proportion of personnel; a copy of the internal auditor's certificate;

(6) Brief introduction of the range, variety and related products to be produced. The product introduction includes at least a description of the product's structural composition, principle, intended use, and product standards;

(7) List of main production equipment and inspection instruments;

(8) Catalogue of production quality management specifications: including documents such as procurement, acceptance, production process, product inspection, storage, delivery, quality tracking, user feedback, adverse event monitoring, and quality incident reporting system, and organization chart of the enterprise;

(9) Process flow chart of the product to be produced, and indicate the main control items and control points. Includes instructions for the control of equipment, personnel and process parameters for critical and special processes;

(10) For the production of sterile medical equipment, a qualified test report of the clean room is required. A qualified inspection report within one year issued by a testing agency recognized by the provincial food and drug supervision and administration department that complies with the "Good Manufacturing Practice for Sterile Medical Devices" (YY0033);

(11) Self-assurance statement of the authenticity of the application materials. List the application materials and make a legal commitment to the materials if they are false. 2. Secondly, your product needs a medical device registration certificate:

Application Materials for Registration of Class I Medical Devices

(1) Application form for domestic medical device registration;

(2) Qualification certificate of medical device manufacturing enterprise: copy of business license;

(3) Applicable product standards and descriptions: Where national standards and industry standards are adopted as the applicable standards for products, the texts of the adopted national standards and industry standards shall be submitted; registered product standards shall be signed by the manufacturer. The production enterprise shall provide a statement that the applied product complies with national standards and industry standards, a statement that the production enterprise assumes quality responsibilities after the product is launched on the market, and a description of the product model and specification division. The "signature" here refers to the seal of the enterprise, or the signature of the legal representative and person in charge plus the seal of the enterprise (the following refers to domestic medical devices, meaning the same);

(4) Product full performance test report;

(5) A description of the existing resource conditions and quality management capabilities (including testing methods) of the products produced by the enterprise;

(6) Medical device manuals;

(7) Self-assurance statement on the authenticity of the submitted materials: It shall include the list of submitted materials and the commitment of the production enterprise to bear legal responsibility. 3. Application for testing by the Technical Supervision Bureau

Medical Device Registration Certificate Procedures

The relevant document stipulates the "Administrative Measures for the Registration of Medical Devices", which contains detailed regulations on this.

Article 5 For registration of first-class medical devices produced by domestic enterprises, the following materials shall be submitted:

(1) Certification of medical device manufacturing enterprise.

(2) Registered product standards and preparation instructions.

(3) Self-test report of full product performance.

(4) Explanation of the existing resource conditions and quality management capabilities (including testing methods) of the company's product production.

(5) Product instruction manual.

(6) Self-assurance statement on the authenticity of the submitted materials.

Article 6 The following materials shall be submitted for the trial production registration of the second and third types of medical devices produced by domestic enterprises:

(1) Certification of medical device manufacturing enterprise.

(2) Product technical report.

(3) Security risk analysis report.

(4) Registered product standards and preparation instructions.

(5) Product performance self-test report.

(6) The product trial production registration type test report issued by the medical device quality inspection institution approved by the State Drug Administration within the past year (the biological material is within half a year before the clinical trial).

(7) Clinical trial reports of two or more clinical trial bases. The report is provided in the manner of implementing the Sub-item Provisions for Medical Device Registration Clinical Trial Reports (see attachment), and the clinical trials are implemented in Administrative Measures for Medical Device Product Clinical Trials.

(8) Product instruction manual.

(9) Self-assurance statement on the authenticity of the materials submitted.

Article 7 The following documents shall be submitted for the quasi-production registration of the second and third types of medical devices produced by domestic enterprises:

(1) Certification of medical device manufacturing enterprise.

(2) A copy of the trial production registration certificate.

(3) Registered product standards.

(4) Product perfection report during trial production.

(5) Valid certification documents of the enterprise quality system assessment (certification).

(6) The product type approval report issued by the medical device quality inspection agency approved by the State Drug Administration within the past year.

(7) Product quality tracking report.

(8) Self-assurance statement on the authenticity of the submitted materials.

Medical Device Registration Certificate Notes

Application materials (1) Product testing standards (1) and (2) above are handled by the Medical Device Division of the Food and Drug Administration (3) are handled by the Municipal Technical Supervision Administration