Medical Devices
CIRS Group
Chemicals
Cosmetic
Food
Medical Devices
Agrochemicals
C&K Testing
Carbon Neutrality
Search

China Class I Medical Devices Record Filing Guidelines

from 未知 by

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:
  1. diagnosis, prevention, monitoring, treatment or alleviation of disease,
  2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  3. investigation, replacement, modification, or support of the anatomy or of a physiological process,
  4. supporting or sustaining life,
  5. control of conception,
  6. 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:
  1. Supporting Doc.
  • Copy of Registration Certificate
  • Copy of Business License
  • Copy of GMP/ ISO13485/ Manufacturing License
  1. Technical Doc.
  • Risk analysis report
  • Technical requirements
  • Self-test report
  • Clinical evaluation materials
  • Manufacturing information
  • POA of China agent
  • Declaration of Conformity
  1. Instruction & Label of the minimum marketing unit
  • Chinese instruction and label Samples
  • Original instruction and label and their Chinese versions
  1. Files From Agent
  • Business License Copy of 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:
  1. 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
  1. 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
  1. 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.
  1. 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 NameIn ChinaIn Europe
医疗器械注册证Registration for Medical DeviceProduct Certificate of Registration
企业营业执照Business LicenseCompany Certificate of Registration
企业生产许可证Production LicenseEC 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 formDocuments
Consistency notarizationCopy of Registration Certificate
Copy of Business License
Copy of GMP/ ISO13485/ Production License
Authenticity notarizationInstruction and Label
Risk analysis report
Technical requirements
Clinical evaluation materials
Manufacturing information
POA of China agent
Certificate of Analysis (COA)
Declaration of Conformity

  

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.

Contact Us
+86 571 8720 6559 (GMT+8 8:30~17:00)
Contact Us
+86 571 8720 6559 (GMT+8 8:30~17:00)