Documents required for registration of Class I in vitro diagnostic reagent products

Basics:

1. "Regulations on the Supervision and Administration of Medical Devices" (Order No. 650 of the State Council of the People's Republic of China, Articles 8, 9 and 10)

2. "Announcement of the State Food and Drug Administration on Matters Concerning the Registration of Class I Medical Devices" (No. 26, 2014)

Charging Standard: No Charge

Period: On the Spot

Scope of application: The filing of Class I in vitro diagnostic reagents shall be handled by the branch directly under the filing party and the district and county Food and Drug Administration (Note: This filing is a new matter, from now until December 2014 A transition period will be established on the 31st. During the transition period, applications for the registration of Class I in vitro diagnostic reagents will be handled by the Beijing Food and Drug Administration)

Procedures:

1. Application and Acceptance

Applicants log in to the Beijing Food and Drug Administration Enterprise Service Platform to apply online. According to the regulations on the scope of processing, they need to submit the following application materials:

(1) First Registration of similar in vitro diagnostic reagents;

1. "Class 1 In Vitro Diagnostic Reagents Registration Form"; (Please go to the Beijing Food and Drug Administration website to fill in and print out the form)

(1) There should be a signature and seal of the person filing the record;

(2) The items filled in should be complete and accurate.

2. Safety risk analysis report;

In vitro diagnostic reagents should be evaluated in all aspects of the product life cycle, including intended use, possible use errors, safety-related characteristics, known and foreseeable hazards, etc. Based on the risk analysis, risk evaluation and corresponding risk control of patient risk estimates, a risk management report is formed.

3. Product technical requirements;

Product technical requirements should be prepared in accordance with the "Guiding Principles for Writing Technical Requirements for Medical Device Products".

4． Product inspection report;

The product inspection report should be a full-performance self-inspection report or a commissioned inspection report, and the inspected products should be typical.

5. Clinical evaluation data;

Clinical evaluation data should include:

(1) Detail the intended use of the product, including the functions provided by the product, and may describe its applicable medical stage (such as post-treatment monitoring, rehabilitation, etc.), the intended users and the skills/knowledge/training they should have to operate the product; the devices intended to be used in combination with it.

(2) Detail the intended use environment of the product, including the places where the product is expected to be used, such as hospitals, medical/clinical laboratories, ambulances, homes, etc., as well as the conditions that may affect its safety and effectiveness. Environmental conditions (such as temperature, humidity, power, pressure, movement, etc.).

(3) Detail the applicable population of the product, including information on the target patient population (such as adults, children or newborns), information on patient selection criteria, as well as parameters that need to be monitored and factors to be considered during use. .

(4) Detail the contraindications of the product and, if applicable, clearly state the diseases or conditions for which the device is prohibited from use.

(5) Comparative description of the clinical use of similar products on the market.

(6) Description of adverse events of similar products.

6. Product instructions and minimum sales unit label design draft;

In vitro diagnostic reagent products should follow the relevant requirements of the "Guiding Principles for Writing Instructions for In Vitro Diagnostic Reagents" and refer to relevant technical guidelines to prepare product instructions.

7. Production and manufacturing information;

In vitro diagnostic reagents should outline the main production processes, including: description and determination basis of solid phase carriers, color development systems, etc. The reaction system includes sample collection and processing, sample requirements, sample dosage, Reagent dosage, reaction conditions, calibration method (if necessary), quality control method, etc.

(2) Registration of changes to Class I in vitro diagnostic reagents:

1. Fill out the "First Class In Vitro Diagnostic Reagents Registration Form" according to the changed content, and the items filled in should be complete and accurate;

2. Description of changes;

3. Comparison list of changes in the filing information table; if the product technical requirements change, a comparison table of changes in product technical requirements should be provided;

4. If the product classification name, packaging specifications, product validity period, or intended use are changed, a safety risk analysis report, product technical requirements, product inspection report, clinical evaluation data, product instructions, minimum sales unit label design sample, and production and manufacturing information should be submitted;

5. The original copy of the "Registration Certificate for Class I Medical Devices".

(3) Cancellation filing for Class I in vitro diagnostic reagents

1. In the "First Class In Vitro Diagnostic Reagents Registration Form", the items filled in should be complete and accurate;

2. The cancellation application must be signed and sealed by the filing person.

(4) Replacement of the lost registration certificate for Class I in vitro diagnostic reagents

1. In the "Class I Medical Device Registration Form", the items filled in should be complete and accurate;

2. Description of the loss (should be signed by the legal person).

(5) In addition to submitting the above application materials, the following application materials are also required:

1. Supporting documents;

Supporting documents should include: A copy of the valid enterprise business license and organization code certificate (if the name or registered address of the filing person is changed, a copy of the changed enterprise business license and organization code certificate should be submitted).

2. Declaration of compliance;

The declaration of compliance should include:

(1) Statement that it meets the relevant requirements for medical device filing;

(2) Declare that this product complies with the relevant content of the corresponding in vitro diagnostic reagent classification subcatalog;

(3) Declare that this product complies with current national standards and industry standards and provide a list of compliance with standards;

(4) Statement on the authenticity of the filing materials submitted.

3. When applying for enterprise declaration materials, if the applicant is not the legal representative or person in charge, the enterprise shall submit a "Letter of Authorization";

4. Catalog of documents and materials submitted for filing;

The table of contents should include all the application materials, and the page number of each item should be stated in the form of a table (if the application materials are large and need to be divided into multiple volumes, the table of contents should include the level 1 and level 2 titles of all the application materials, and the volume and volume of each item should be stated in the form of a table). page number).

2. Standards:

1. The application materials should be true, complete, clear and neat, and must be signed and sealed by the filing person; (Signature and seal means: the seal of the filing person, or the signature of the legal representative or person in charge plus the seal of the company. The seal must be the filing person's seal Official seal, special registration seal is not allowed)

2. Application materials, except supporting documents, should be provided in Chinese. If the supporting documents are in a foreign language, a Chinese translation should also be provided. Application materials translated based on foreign language materials should be accompanied by the original text.

3. The forms filled out by the applicant and the application materials prepared by the applicant should be on A4 size paper, and the original documents issued by the government and other institutions should be provided in their original size;

4. If a copy of the application materials should be submitted, the copy should be clear, and the copy should be marked with the date and the signature of the filing person;

5. Application materials should generally have a left margin greater than 20mm (for file binding);

6. The same items in the application materials should be filled in consistently;

Extended information:

"Registration Management Measures for In Vitro Diagnostic Reagents" (State Food and Drug Administration Order No. 5)

Product Registration

Article 67 Before the production of Class I in vitro diagnostic reagents, product registration must be completed.

Article 68: When handling the filing of in vitro diagnostic reagents, the filing party shall submit filing materials in accordance with the provisions of Article 9 of the "Regulations on the Supervision and Administration of Medical Devices".

If the filing materials meet the requirements, the food and drug regulatory department shall file them on the spot; if the filing materials are incomplete or do not meet the prescribed form, all the content that needs to be supplemented and corrected shall be notified at once, and the filing person shall make the corrections and file them for the record.

For registered in vitro diagnostic reagents, the food and drug regulatory department shall prepare a registration certificate in the relevant required format and publish the information published in the registration information form on its website.

Article 69: For registered in vitro diagnostic reagents, if the content published in the registration information table and the registered product technical requirements change, the filing party shall submit a description of the changes and relevant supporting documents to the original filing The department proposes changes to the filing information. If the filing materials meet the formal requirements, the food and drug regulatory department shall publish the changes in the change information and archive the filing materials.

Article 70: If the management category of a registered in vitro diagnostic reagent is adjusted, the filer shall proactively propose to the food and drug administration department to cancel the original registration; the management category shall be adjusted to Category II or Category III in vitro diagnostics. For reagents, application for registration shall be made in accordance with the provisions of these Measures.

Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650)

Article 9 Registration of Class I Medical Device Products and Application for Class II and Class III Medical Device Products For registration, the following information should be submitted:

(1) Product risk analysis information;

(2) Product technical requirements;

(3) Product inspection report;

(4) Clinical evaluation data;

(5) Product instructions and label samples;

(6) Quality management system related to product development and production Documents;

(7) Other information required to prove the safety and effectiveness of the product.

Medical device registration applicants and filers shall be responsible for the authenticity of the materials submitted.