Attachment I

Requirements and Instructions for Filing Data of Class I Medical Devices

I.Filing Data

(A)Filing form for Class I medical devices

(B)Safety risk analysis report

Prepare the report according to the relevant requirements specified in YY 0316 "Application of Risk Management to Medical Devices", and the content of the report mainly include judgment of the intended use of the medical device and safety-related features, determination of hazards, and the assessment of the risk of each hazardous situation; for each determined hazardous situation, evaluate and determine whether needed to reduce the risk; results of implementation and verification of risk control measures, and provide a reference to the inspection and evaluation of reports as necessary; assessment of the acceptability of any one or more of the residual risks, and forming a risk management report.

For IVD products, a risk management report shall be prepared based on the risk analysis, risk evaluation and corresponding risk control over the intended use, possible miss use, safety-related features, determination of known and foreseeable hazard as well as estimate of the risk patients during each link of the product life cycle.

(C)Technical requirements

Technical requirements should be prepared in accordance with the "Guidelines for Preparation of Technical Requirements of Medical Devices".

(D)Product inspection report

The product inspection report shall be self-test report or commission inspection report of the full-item product performance, and products tested should be typical models of the product.

(E)Clinical evaluation data

1.Detail the intended use of the product, including the functionality the product provided, and describe the applicable medical stage (such as post-treatment monitoring, rehabilitation, etc.) of the product, the target users of the product and the skills / knowledge / training required for the operation of the product; devices expected to be used with or to be combined with.

2.Detail the expected use environment of the product, including the intended use location of the product, such as hospital, medical / clinical laboratories, ambulance, family, etc., and the environmental conditions (such as temperature, humidity, power, pressure, moving) that may affect their safety and effectiveness.

3.Detail the population the product applicable to, including information about the target patient population (eg adults, children or newborns), information about patient selection criteria, and the parameters needed to be monitored during the use of the process, and factors to be considered.

4.Detail contraindications of the product, a disease or condition shall be prohibited from the use of the product should be clearly stated if applicable.

5.Description of the comparison with the clinical use of the listed similar products.

6.Description of the adverse events of similar products.

(F)Instruction for Use of the product and label design sample of the smallest sales unit

The IFU of the medical devices shall comply with the requirements of the regulations. A copy of the IFU in its original language and Chinese translation text approved or recognized by oversea governmental authorities should be submitted for imported medical products.

For IVD products, IFU should be prepared in accordance with the relevant requirements of "Guidelines for Preparation of IFU of In Vitro Diagnostic Reagents", with reference to the relevant technical guidelines. For imported vitro diagnostic reagents, a copy of the IFU in its original language and Chinese translation text approved or recognized by oversea governmental authorities should be submitted for imported medical products.

(G)Manufacturing information

An overview of the production process-related conditions shall be provided. For passive medical devices, the production process should be clearly stated, and the key processes and special process shall be noted. For active medical devices, descriptive information about the production process should be provided, it may be in the form of a flowchart, which is an overview of the production process.

For IVD products, the main production processes should summarized, including description of the solid phase carrier, and the color developing system and its determination basis, and the reaction system including the sample collection and handling, sample requirements, sample size, reagent amount, reaction conditions, calibration method (if necessary), and quality control methods.

Description of the actual condition of the development and production of the product shall be provided.

(H)Proof documents

1.Documents the domestic filing party shall provide: a copy of business license and a copy of the organization code certificate.

2.Documents the oversea filing party shall provide:

(1)Corporate qualification documents of the oversea filing party.

(2)Proof documents on the marketing of the product issued by the department in charge of medical devices in the country (region) where the registration address or the production address locates of the oversea filing party. For products that are not managed as medical devices in the country (region) where the registration address or the manufacture address locates of the oversea filing party, the filing party is required to provide relevant documents, including a proof document on the legal marketing of the product issued by the department in charge of medical devices in the country (region) where the registration address or the production address locates. If the document is a copy, it shall be notarized by a local notary office.

3.A copy of the power of attorney of the oversea filing party designating agent in China, a copy of the letter of commitment of the agent and copy of business license or registration certificate.

(I) Statement of conformity

1.Statement on compliance of the filing medical devices with requirements;

2.Statement on this product meeting the requirements of catalog of class I medical devices or the sub-catalog of appropriate in vitro diagnostic reagents;

3.Statement on this product complying with current national standards or industry standards, and  provide a list of standards-compliant;

4.Statement on the authenticity of the filling data submitted.

II.Change of the filing data

(A)Description of the changes and related proof documents

For description of the changes, a comparison form on the changed content of the filing data should be attached.

For changes related to technical requirements of the product, a comparison form on the changed  content of the technical requirements should be attached.

For changes related to the product name (for in vitro diagnostic reagents, referring to the product category name, the same for content below), product description, and intended use, the content after change should be consistent with the catalog of class I medical devices or the sub-catalog of appropriate in vitro diagnostic reagents. Among them, the product name should be the same as that listed in the catalog; the product description or intended use should be the same as or less than that listed in the catalog.

The appropriate proof documents should be detailed, comprehensive and accurate.

(B)Proof documents

1.Documents the domestic filing party shall provide: a copy of business license and a copy of the organization code certificate.

2.Documents the oversea filing party shall provide:

(1)If the change content requires the filing party to obtain a new proof document of the marketing of the product issued by the department in charge of medical devices in the country (region) where the registration address or the manufacture address locates of the oversea filing party, then the new proof document of the marketing of the product should be submitted. If the document is a copy, then it shall be notarized by a local notary office.

(2)A copy of the power of attorney of the oversea filing party designating agent in China, a copy of the letter of commitment of the agent and copy of business license or registration certificate.

(C)Statement of conformity

1.Statement on compliance of the filing medical devices with requirements;

2.Statement on this product meeting the requirements of catalog of class I medical devices or the sub-catalog of appropriate in vitro diagnostic reagents;

3.Statement on this product complying with current national standards or industry standards, and provide a list of standards-compliant;

4.Statement on the authenticity of the filling data submitted.

Attachment: Form requirements for the filing data

Attachment

Form requirements for the filing data

I.The filing data shall be complete and integrate. The filling of the filing form shall be complete.

II.The documents except for proof documents should be provided in Chinese form. If the proof documents are in foreign language, they should be provided in the form of Chinese translation. For applying data based on translation of data in foreign language, the original copy shall be also provided.

III.For the filing data of domestic product, unless otherwise specified, they shall be signed and sealed by the filing party. The "signature and seal" means sealed by the filing party, or signed by the legal representative or responsible person of the filing party and sealed. The seal must be the official seal of the filing party, and it shall not be the registration seal.

IV.For the filing data of imported product, unless otherwise specified, the original data should be the original copy and signed by the filing party, and the Chinese text shall be signed by the agent in China. The "signature and seal" on original data means signed by the legal representative, or responsible person, or signed plus sealed with the organization seal, and a notary copy by local notary organization shall be submitted; Chinese data "signature " means : Agent organization seal, or their legal representative, responsible person plus organization stamped signature .The "signature and seal" on Chinese data refers to sealed with the organization seal, signed by the legal representative plus sealed with the organization seal.

V.The filing data should be provided with a Table of Content of the data submitted, including  Level one titles and Level two titles of the whole dossier, and describe each volume and page number in tabular form.