New announcement focus

1.The new filing materials are required to be written in more detail,If the product has microbial limit requirements,It is necessary to specify what measures are taken to make the products comply with the regulations.After filing,The supervision department shall focus on reviewing the authenticity of the recorded materials,It is not only to check whether the site meets the requirements.According to the new announcement,After filing,One more Notification of filing number of class I medical devices .

2.If the product needs to be sterilized or disinfected by the user according to the instructions before use,Corresponding verification report shall be provided when filing.In the past, this kind of situation was encountered only when the classification was defined,Required by the National Bureau.Now, as long as the recorded products involve the above situations,Enterprises are required to provide verification reports.

3.If the category of the previously recorded products is adjusted to category II or III,It is necessary to cancel the filing actively,Apply for registration.If some products are no longer managed as medical devices,It shall also take the initiative to cancel the filing,If you don't take the initiative,The filing department may directly announce the invalidation of the Filing Certificate.

4.The new announcement particularly stresses that enterprises that provide false information should be punished,Serious,In addition to fines,Relevant person in charge5This industry is prohibited during the year.

Announcement of the State Food and Drug Administration on matters related to the filing of class I medical devices(2022Year62number)

      In order to do a good job in the filing of class I medical devices,according to Regulations on the supervision and administration of medical devices  Order of the State Council No739number   Administrative measures for registration and filing of medical devices  Order of the State Administration of market supervision No47number   Administrative measures for registration and filing of in vitro diagnostic reagents  Order of the State Administration of market supervision No48number ,For the first category of medical devices Including class I in vitro diagnostic reagents Relevant matters for filing are announced as follows:

One Medical device filing refers to the person who files the medical device (hereinafter referred to as the recorder) Submit the filing materials to the drug regulatory department in accordance with the legal procedures and requirements,Activities of the drug regulatory department for filing the submitted filing materials for future reference.

Two Domestic class I medical device filing,The filing person shall submit the filing materials to the drug supervision and administration department at the municipal level divided into districts.Filing of imported class I medical devices,The filing person shall submit the filing materials to the State Drug Administration.

Three When determining the product management category,It shall be combined with the actual situation of the product,according to Category I medical device product catalog  Subcategory of in vitro diagnostic reagents Product description in the regulations The intended use and product name shall be judged by examples.

according to Category I medical device product catalog  Subcategory of in vitro diagnostic reagents  (hereinafter referred to as the "Catalogue") And the results of relevant classification and definition, etc. are determined to be class I medical devices,The filing person shall handle the filing with the corresponding filing department Beyond the contents of the directory,Apply for classification and definition according to relevant work procedures,Clearly classified as class I medical devices,File with the corresponding filing department.

Four Handle medical device filing,The recorders shall submit the documents that meet the requirements (see attachment)1 Filing materials of,Fill in the filing form (see attachment)2 ,Obtain record number.The recorders shall ensure that the materials submitted are legal real accuracy Complete and traceable.

Five The ARCHIval filing shall be completed after the ARCHIval filing materials that meet the requirements of Annex 1 are submitted. For the medical devices for the record, the record department shall provide the record number to the record holder (see Annex 3 for the notice of record number), and publish the relevant information in the Record Information Form for Class I Medical Devices or the Record Information Form for Class I in Vitro Diagnostic Reagents (see Annex 4) within the prescribed time.

Six For the medical devices that have been put on record, the contents in the record information sheet and the technical requirements of the products put on record have changed, the record holder shall change the record to the original record department, and submit the explanation of the changes and related documents. For the medical devices that are changed for filing, the filing department shall publish the changes in the column of "Changes" in the filing information sheet, and publish the relevant information of changes in accordance with the prescribed time.

Seven The filing department shall carry out the filing work in accordance with the operating specifications for the filing of Type I medical devices (see Annex 5).

Eight The arrangement of record numbers of Class I medical devices is as follows:

×1 equipment ×××× ×2××××3. Among them:

×1 is the abbreviation of the place where the filing department is located:

Imported class I medical devices shall be "country";

The first type of medical devices in China shall be referred to as the province, autonomous region or municipality directly under the Central Government where the recording department is located plus the administrative region of the municipality where the district is located (if there is no corresponding administrative region of the municipality divided into districts, it shall only be referred to as the province, autonomous region or municipality directly under the Central Government);

××××2 is the record year;

××××3 is the archival serial number.

Nine   The State Food and Drug Administration shall establish a record information platform to collect the record information of Class I medical devices; The provincial drug regulatory department is responsible for collecting and submitting the record information of Class I medical devices within its jurisdiction. For archival filing, the archival department shall publish the relevant information in the archival information form on its website within the prescribed time, and the provincial drug regulatory department shall, as required, timely submit the archival information of Category I medical devices within the territory to the archival information platform of the State Medical Products Administration.

To change for the record, for the record of the ministry of the situation will be posted to record information table column change situation, change its website in accordance with the stipulated time of relevant information, pharmaceutical supervisory and administrative departments at the provincial level according to the requirements will change in class I medical devices within the territory of the record information and report to the state department of pharmaceutical administration for the record information platform.

This announcement shall take effect as of the date of promulgation. The Announcement on Matters Relating to the Filing of Class I Medical Devices (No. 26 of 2014) issued by the former State Food and Drug Administration shall be abrogated at the same time.

This is hereby announced.

Attachment:

1. Requirements and instructions for the record materials of Class I medical devices

2. Class I Medical Device Record Form (format)

3. Notification of Record number of Class I medical devices

4. Class I medical device record information sheet and Class I in vitro diagnostic reagent record information sheet

5. Operating specifications for the record of Class I medical devices

State Food and Drug Administration

On August 10, 2022

Annex 1 Record data requirements and description of Class I medical devices

One. Archival materials

1. Record form of Class I medical devices

2. Associated files

1）The domestic filing party shall provide: a copy of the business license of the enterprise or a copy of the legal person certificate of the institution.

Where production is entrusted to another enterprise, the company shall provide the qualification documents of the entrusted enterprise (a copy of the business license), a copy of the entrusted contract and a copy of the quality agreement.

2）The overseas filing party shall provide:

① Enterprise qualification certificate of the overseas filer: the certificate issued by the company registration authority of the country (region) where the overseas filer is registered or the medical device competent authority that can prove the existence of the overseas filer and the production qualification of the corresponding medical device; Or the certification documents issued by the third party certification authority for the overseas record-holder to prove that the overseas record-holder has the corresponding qualification for the production of medical devices.

② The certificate issued by the competent department of medical devices in the country (region) where the overseas archival person is registered or where the production place is located allowing the product to be put on the market. If the product is not managed as a medical device in the country (region) of the registration place or the production place of the record-holder, the record-holder shall provide relevant documents, including the documents certifying that the product is allowed to be marketed in the country (region) of the registration place or the production place of the record-holder. The innovative medical devices that are not listed in the country (region) where the overseas filing party is registered or where the production place is located may not be submitted.

③ The power of attorney, the letter of commitment and the copy of the business license of the agent designated by the overseas filer in China.

3.Product technical requirements

Product technical requirements should be prepared in accordance with the Guidelines for the Preparation of Technical Requirements for Medical Device Products, which mainly include functional and safety indicators and testing methods of medical device products that can be objectively determined.

4. Product inspection report

The product inspection report shall be the self-inspection report of the full performance of the product or the entrusted inspection report, and the products to be inspected shall be typical.

The inspection report is accompanied by photos of the product. The photos of the products shall include the photos of the samples after removing all the inside and outside packaging, and the photos of the actual samples of the inside and outside packaging. Multiple models and specifications, provide photos of typical products.

5. Product specifications and minimum sales unit label design samples

The instructions and labels shall comply with the Provisions on the Management of Instructions and Labels for Medical Devices and Guidelines for the Preparation of Instructions for in Vitro Diagnostic Reagents, etc. The product performance in the instructions shall be consistent with the corresponding contents in the technical requirements of the products. For imported products, the original version of the manual and its Chinese translation approved or approved by the competent department of the government abroad shall be submitted.

6. Production and manufacturing information

An overview of the production process. Production and processing technology of passive medical devices should be specified, and key processes should be specified. Active medical devices should provide descriptive information about the manufacturing process of the product, either in the form of a flow chart or an overview of the manufacturing process. The main production process of in vitro diagnostic reagents should be outlined, including the description and determination basis of solid phase carrier and color development system, etc. The reaction system should include sample collection and processing, sample requirements, sample dosage, reagent dosage, reaction conditions, calibration method (if necessary), quality control method, etc.

Where there are more than one research and production site, the actual situation of each research and production site shall be summarized.

Where production is entrusted to another enterprise, the name, domicile and production address of the entrusted enterprise shall be listed.

7. Declaration of conformity

1) Declare that it meets the related requirements of Class I medical device filing;

2) Declare that the product meets the requirements and basis of relevant classification, including the relevant contents of Category I Medical Device Product Catalogue or in Vitro Diagnostic Reagent Classification Sub-Catalogue, and the exact basis of product classification should be indicated, and the sub-catalogue, Grade I and Grade II product categories to which the product belongs should be specified;

3) Declare that the product meets the current national and industrial standards and provide a list of standards;

4) Declare the authenticity of the archival materials submitted (the domestic products shall be issued by the archival party, and the imported products shall be issued by the archival party and the agent respectively).

Two. Change the archival materials

(1) Description of changes and related documents

The description of changes should be attached to the record information table and the comparison table of changes.

Where changes in product technical requirements are involved, a comparison table of changes in product technical requirements and a product inspection report (if any) shall be provided.

(2) Associated files

If the changes involve changes in related documents for the record, a new related document shall be submitted.

The overseas filing party shall also submit the power of attorney, the letter of commitment of the agent and the copy of the business license of the agent designated within the territory of China.

(3) Declaration of conformity

1. Declare that it meets the related requirements of Class I medical device filing;

2. Declare that the product meets the requirements and basis of relevant classification, including the relevant contents of Category I Medical Device Product Catalogue or in Vitro Diagnostic Reagent Classification Sub-Catalogue, and the exact basis of product classification should be indicated, and the sub-catalogue, Grade I and Grade II product categories to which the product belongs should be specified;

3. Declare that the product meets the current national and industrial standards and provide a list of standards;

4. Declare the authenticity of the archival materials submitted (the domestic products shall be issued by the archival party, and the imported products shall be issued by the archival party and the agent respectively).

Three. Content requirements of archival materials

(1) Product name (product category name)

In principle, product names (excluding in vitro diagnostic reagents) should be directly used as the names listed in "Examples of Product Names" in Category I Medical Device Product Catalogue; If it is really necessary to adjust the product name for filing, the name shall be in accordance with the Rules for Naming General Names of Medical Devices (Order No. 19 of the State Food and Drug Administration) and the relevant naming guidelines.

The product classification name (product name) of in vitro diagnostic reagents shall be the product classification name (product name) in the SubCatalogue of in Vitro Diagnostic Reagents Classification.

(2) Product description and intended use

"Product Description" and "Intended Use" shall comply with the corresponding requirements in the Category I Medical Device Product Catalog and the SubCatalog of Classification of In Vitro Diagnostic Reagents (hereinafter referred to as the catalog), and shall not exceed the scope of "Product Description" and "Intended Use" and related contents in the catalog.

Under the product description item in Category I Medical Device Product Catalog, the phrase "usually used by... "Composition", the relevant content only gives the representative structural composition of the product. At the time of filing, the structure composition may be described according to the actual situation of the filing product; Do not use the phrase "normally used by... ", instead of "made up of... Composition ", and specify the specific composition. If there are limiting statements such as "one-time use", "repetitive use", "passive product", "paste site is intact skin", "does not have dose control function" and "non-sterile provision", the "product description" of the recorded product should be clear.

(3) Model/specification

The model/specification shall not contain any indication or implication of cure, exaggeration of intended use, or other misleading or deceptive content.

(4) The name and domicile of the filing party

The NAME AND DOMICile OF THE filer IN the filing form of the domestic filer shall be consistent with those in the business license of the enterprise or the legal person certificate of the public institution. The name, domicile and production address of the recordholder in THE recordkeeping form of THE overseas RECORdholder shall be consistent with the documents related to the overseas recordholder.

(5) Power of attorney and letter of commitment of agent designated by the overseas filing party

The content of entrustment and commitment in the power of attorney and the letter of commitment of the agent designated by the overseas filer shall be consistent with the content of the record.

(6) Instruction manual

The contents related to product description in the manual (including but not limited to the parts related to product description, such as structure composition, main composition, expected use, use mode and precautions) shall not exceed the corresponding contents in other archived materials.

If the product is sterilized or disinfected by the using organization according to the instructions before use, the product instructions submitted at the time of filing shall provide a proven method of sterilization or disinfection.

Four. Requirements on the form of archival materials

(1) Complete and complete archival materials. The filing form is complete.

(2) All documents except associated documents shall be provided in Chinese. If the relevant document is in a foreign language, a Chinese translation shall be provided and signed by the agent. Materials translated from materials in a foreign language shall also be provided in the original.

(3) If there is no special explanation for the archival materials of domestic products, the archival materials shall be signed and sealed by the archival persons. "Signature and seal" means that the official seal is affixed by the recordholder, or the official seal is affixed by the legal representative or the person in charge of the recordholder.

(4) If there is no special explanation for the archival materials of import products, the original materials shall be signed and sealed by the archival person, and the Chinese materials shall be signed and sealed by the agent. "Signature and seal" means the signature of the legal representative or the person in charge of the record holder, or the signature plus the seal of the organization; "Signature" means the official seal of the agent, or the signature and seal of the legal representative or the person in charge of the agent.

(5) The related documents, declaration of conformity, specification and label provided by the overseas archival party in the archival materials of import products shall be submitted to the notarization document issued by the notarial office in the place where the archival party is located. The notarization document may be handled through the electronic notarization mode, but at the same time, a document explaining the notarization mode issued by the filer outside the country shall be submitted.

(6) Where a recordholder submits the materials for archival filing in paper form, the materials for archival filing shall have a catalogue of the materials to be submitted, including the primary and secondary titles of the materials for archival filing, and the page number of each item shall be indicated in tabular form.

Five. Other requirements

(1) Products under the following two conditions shall be put on record according to the following requirements:

1. For Class I medical device products that are provided as non-sterile at the time of delivery, they should be sterilized or disinfected by the using institution according to the instructions before use to meet clinical needs (e.g. Non-aseptically provided reusable ophthalmic scalpel), the item "Product description" should specify "non-aseptically provided, sterilized by the using organization according to the manual before use" or "non-aseptically provided, sterilized by the using organization according to the manual before use"; The sterilization or disinfection method shall be provided in the "Product Instruction Manual", and the sterilization and disinfection method provided and the number of sterilization and disinfection times the product can bear shall be confirmed.

2. For a factory for non sterile, no longer before use for sterilization or disinfection, but in order to meet the demand of clinical itself has microbial limit of class I medical devices products (for example: contact of class I medical devices shall be in accordance with the management of wound dressing), shall be expressly specified under "product description" should conform to the requirements of the microbial limit; The "product Technical requirements" shall indicate the microbial limit requirements to be met; The "manufacturing Information" shall indicate: what measures have been taken by the manufacturer to make the product meet the specified microbial limit requirements; Which microbiological limit requirements (if applicable) are currently met.

(2) "09-02-03 physical cooling equipment", "09-03-08 light Therapy Equipment Accessory", "14-10-02 Band-Aid" and "20-03-11 Acupoint pressure stimulator" in the First Category of Medical Device Product Catalog; It shall not contain traditional Chinese medicine, chemical drugs, biological products, disinfection and antibacterial ingredients, natural plants and their extracts and other ingredients that exert pharmacological, immunological and metabolic effects or can be absorbed by the human body, including but not limited to the ingredients listed in the Appendix of Category I Medical Device Product Catalog.

When archiving "09-02-03 Physical Cooling Equipment" in the Catalogue of First Class Medical Device Products, the name of the product shall be directly the name listed in the Catalogue "Example of Product Name", and the intended use shall not exceed the intended use stipulated in the catalogue.

(3) about the combination package products. If a product is a combination of more than one medical device that needs to be used together to achieve a certain intended use, if all the products in the combination are Class I medical devices (shall not contain any form of non-medical device products), and the intended use of each component device is not changed after the combination, it can be recorded as Class I medical devices. The product name should reflect the combination characteristics, and in principle, it should be named according to its main clinical intended use. The composition of the name should be within the "product category (Grade 1 or 2)" of the catalog and the "intended use" scope of the products included, such as upper limb internal fixation surgical instruments (packages), knee joint surgical instruments (packages), etc. At the same time, the "Product Description" should include all the medical devices, and explain the "Product description" and "intended use" of each medical device, and its basic contents should be consistent with the corresponding contents in the catalog. The classification code of the package is the medical device that plays a major role in its intended use.

Attachment

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2. Class I Medical Device Record Form (format)

3. Notification of Record number of Class I medical devices

4. Class I medical device record information sheet and Class I in vitro diagnostic reagent record information sheet

5. Operating specifications for the record of Class I medical devices