China Class I Medical Devices Record Filing Guidelines

1. Background

Since June 1st, 2014, the newly revised Regulations for the Supervision and Administration of Medical Devices (State Council Decree No. 650, named Regulation as follow) substitutes the former implemented ordinance. The revised regulation cancel registration process for Class I medical device, which means Class I medical devices are no longer required for the pre-market administrative approval. You just need to prepare materials as corresponding requirements, and record your products in the local municipal drug administration department, the record certificate will have its effectiveness permanently, and without the need for the continuation.

2. Definition

Medical device means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:

diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
investigation, replacement, modification, or support of the anatomy or of a physiological process,
supporting or sustaining life,
control of conception,
providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.

3. Classification

Medical device is classified by its degree of risk.
Class I Medical devices &IVDs are those with low risk degree and for which safety and effectiveness can be ensured through routine administration.

3.1 Class I Medical Device Catalogue:

According to the medical device classification rules, we can find that the following varieties usually be managed as Class I.

3.1.1 Passive medical device which contact human body

Medical Dressing, which is used for Skin/Cavity (Mouth) only, and the intended term for consecutive use of the device is within 30 day.
Insertion Instrument, which is used for Skin/Cavity (Mouth) only, and the intended term for consecutive use of the device is within 24 hour.
Reusable Surgical Instrument, which is used for Skin/Cavity (Mouth) and Body tissue, and the intended term for consecutive use of the device is within 24 hour.
Other Passive Device, which is used for Skin/Cavity (Mouth), and the intended term for consecutive use of the device is within 24 hour.

3.1.2 Passive medical device without contacting

Care equipment and other general passive devices with no impact basically.

3.1.3 Active medical device without contacting

Laboratory test equipment and other general active medical devices with no impact basically.

3.2 Class I IVDs Catalogue:

Microorganism culture medium (excluding for microorganism identification and medicine allergic assay)
Products for specimen treatment, such as hemolytic agents, diluents, staining solutions, etc.

4. Record Filing Procedures and Requirements

4.1 Record Filing Procedures

Step 1.Classfication

Determine the classification of your product based on Chinese regulations and make sure that your product is managed as Class I medical device in China.

Step 2. Designation of China Agent

Designate an agent who is registered in China and will coordinate and control your CFDA registration, as well as undertake the corresponding legal liability.

Step 3. Dossier Preparation

Prepare relevant record documents. As following:

Supporting Doc.	Copy of Registration Certificate
	Copy of Business License
	Copy of GMP/ ISO13485/ Manufacturing License
Technical Doc.	Risk analysis report
	Technical requirements
	Self-test report
	Clinical evaluation materials
	Manufacturing information
	POA of China agent
	Declaration of Conformity
Instruction & Label of the minimum marketing unit	Chinese instruction and label Samples
Instruction & Label of the minimum marketing unit	Original instruction and label and their Chinese versions
Files From Agent	Business License Copy of agent
Files From Agent	Letter of commitment of agent

Step 4. Fill Application Form on line

Login on line Registration Management Information System. Fill your information and submit, the system will automatically generate the application form for you. Printthe application form. The application form must be signed and sealed by your China Agent.

Step 5. Dossier Submission

Please be well noted that you shall post the paper submission to CFDA or do the live submission in CFDA within 30 days after you submit the on line application form. Otherwise, you have to re-fill and submit the application form online again.
You will receive a Record certificate when your application successfully passes CFDA review. And afterwards you don’t need to renew your certificate in case that the classification of your product is not changed from Class I to Class II/III.

5. Record Filing Documentation Requirements

As following:

Supporting Doc.	Copies shall be signed by your legal person and sealed
	Copies shall be notarized by your local law office and indicate that they are consistent with the originals
	Copies shall be translated in Chinese, and the translations must be sealed and signed by your China Agent
Technical Doc.	Documents shall be translated in Chinese
	The translations shall be signed by your legal person and sealed
	Above resulting docs shall be notarized by your loal law office and indicate that the seal and signature are authentic
	The copies of the translations shall be sealed and signed by your China Agent
	Note: Foreign self-test reports and foreign clinical data of Class I medical devices are generally accepted by CFDA
Instruction & Label of the minimum marketing unit	Files shall be signed by your legal person and sealed
	Files shall be notarized by your local law office and indicate that the seal and signature are authentic.
	The copies of the files must be sealed and signed by your China Agent.
Files From Agent	The files are sealed and signed by your China Agent

6. Common Record Filing Errors

The common record filling errors always happen in the Step 3, Dossier Preparation.

6.1 License Error

The different name of license between Europe and China leads to the manufacturer cannot know which licenses are required. So they always submit the wrong license to CFDA.
What are their names of corresponding certificates in Europe?

Chinese Name	In China	In Europe
医疗器械注册证	Registration for Medical Device	Product Certificate of Registration
企业营业执照	Business License	Company Certificate of Registration
企业生产许可证	Production License	EC Certificate & Declaration of Conformity

6.2 Notarization Error

Pursuant to Operation Specification of Registration Approval for Class III Medical Device and Imported Medical Device, the original documents of application for imported medical device shall be sealed and signed by your legal person. And all the documents shall be notarized.
Document notarization is divided into consistency notarization and authenticity notarization. Some manufacturers will make a confusion of notarization

Consistency notarization refers to the copies of certificates are consistent with the originals.
Authenticity notarization refers to refers to the seal and the signature is authentic.

Notarization form	Documents
Consistency notarization	Copy of Registration Certificate Copy of Business License Copy of GMP/ ISO13485/ Production License
Authenticity notarization	Instruction and Label Risk analysis report Technical requirements Clinical evaluation materials Manufacturing information POA of China agent Certificate of Analysis (COA) Declaration of Conformity

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