Ahead of Medical Device Registration in China

Product classification and product code of Medical Device

Similar to product code at FDA, you can classify your produce by yourself!

Product classification of medical device in China

There are three classes (I, II and III) of medical device in China. The higher risk the medial device undertakes, the higher classification it belongs to. Class I medical device need just listing (file filing) and Class II and III medical device require extensive approval process (article 13, 15 and 16, state council order 739, 2021).

The certificate of class I MD is without expiration and the one of Class II and III MD are valid for 5 years.

To classify your product, you need intended use, then match with classification catalog in China. The rule of classification is just supporting but not deciding guidance.

Here is example of three classifications in China. With more risk, more requirements in term of dossier and clinical dokumentation are needed.

•   01  Active Surgical Devices
•    02  Passive Surgical Devices
•    03  Neurological and Cardiovascular Surgical Devices
•    04  Orthopaedic Surgical Devices
•    05  Radiotherapy Devices
•    06  Medical Imaging Devices
•    07  Medical Diagnostic and Monitoring Devices
•    08  Respiratory, Anaesthetic and First-aid Devices
•    09  Physiotherapy Devices
•    10  Blood Transfusion, Dialysis and Extracorporeal Circulation Instruments
•    11  Disinfection and Sterilization Devices of Medical Devices
•    12  Active Implantable Devices
•    13  Passive Implantable Devices
•    14  Injection, Nursing and Protection Devices
•    15  Patient Bearing Devices
•    16  Ophthalmic Devices
•    17  Dental instruments
•    18  Gynaecological and Obstetrical, Assisted Reproduction and Contraceptive Devices
•    19  Medical Rehabilitation Devices
•    20  Equipment Used in TCM
•    21  Medical Software
•    22  Clinical Examination Instruments

We established a first classification TOOL to look product code in English up. By giving the product keywords in English you can search the product code easily.

As shown in figure 2, the example of medical software belongs to 21-xx-xx (Stand alone Medcial Software). Among 5 sub-categories the product matches the therapeutic planning software 21-01-xx. Compare to the last 2 digits with different intended uses at catalog, it leads to the result of product code 21-01-01, Radiotherapy planning software, class III.   

Man starts to compare intended use of subject medical device with it in product code catalog. To underscore is that your medical device must be WITHIN the scope of description in product code catalog, must NOT be the same, however NOT exceed the description. The classification of medical device is given in catalog.

Known the product code, you can have a screen on exemption catalog for clinical study. As well you should compare to the description in this catalog. Under the same product code it can be exempted for clinical study or in opposite depending on the intended use.

In the end you can search product specific guidance and standards with identified product code.

Good trend!

Every year NMPA issues a revised list of determined new product classification. The good trend is there are more and more medical devices down classified due to less safety concerns and raising quantity of equivalent products at market.

How to determine classification if no classification is found in released catalog

(free of charge at authority)

If you cant match your medical device with classification catalogue, you can apply (for free) for determination of product class.

The results can be

1.      No medical device

2.      Medical device matching which product code, class I or II and III

3.      Class III medical device

You need to be aware to submit following documents:

·        Application form

·        Product picture and structure diagram

·        Product technical requirement and instruction for use

·        Home country certificate, if applicable

·        Statement of truthiness

·        Another documents supporting determination of product class

·        Similar products approved in- and outside of China, comparison with related product class at classification catalogue

·        Academic papers, monographs and document reviews published in core publications that can fully explain the clinical application value of the product, if applicable

·        Innovative content of the product

·        Novelty reports issued by information or patent search agencies

Contact us via info@easychinapprov.com, if you want to match your Chinese product code and classification.

It is not a fix determination of product class, you can adjust your Chinese intended use, you can shorten your indication for use, you can make an intended use for non medical device and another one with intended medical use.

Type of Registration of Medical Device

There are three types of product registration of medical device in China:
 

• Initial registration
• Change registration (in administration matter and in significant change/modification matter)
• Extension/Renewal

As in figure 4 shown, change registration applies normally to new product release which needs new "declaration of conformity". The product certificate is not unlimited valid. The certificate of class II and III medical device is only 5 years valid.

1. Initial registration
It applies to all medical devices which are initially marked in China.

2. Change registration or Re-registration
There are two types of change registration: in administration matter and significant change/modification matter.

*The change registration in significant modification matter is abbreviated in text to change registration at whole website

Change registration (in administration matter)
By change of:

• name or address of overseas manufacturer
• name or address of Chinese agent

Change/modification registration (in significant modification matter)
By change of:
 

• Address of overseas manufacturing site
• Models, specifications, structure, composition, intended use on certificate!
• Annex of certificate: product technical requirement (PTR)!
• Model, variant
• Composition, configuration, core component, material
• Intended use
• New features with different functional performance specifications
• New software version in significant change matter!

(e.g. Version 1.0 to Version 2.0 bearing the change of software environment or safety level or significant cybersecurity etc.)

• Obligatory standards!

3. Extension (Renewal of certificate every 5 years)

The NMPA certificate is 5 years valid. Normally you should start preparing the renewal of NMPA certificate 6 months before the expiration date of certificate if there is no significant change of product or new valid regulation. Similar to change registration if new obligatory product specific standards apply to your product, you have to start FIRSTLY a change registration and SECONDLY a renewal and to initial oft new type testing ca. 1-2 years before the expiration time of certificate.

It is not uncommon at the moment NMPA asks for a shelf life test due to the recently valid standards of shelf life, usability test will probably come soon.

Global trend of medical device

Do you know that prerequisite, classification, product code (group), registration pathway, type of registration is essential part of professional proposal?

Below was an exceptional tool in Singapore to evaluate device classification and registration requirement.

We garantee always a free consulting stage with medical device manufacturer to define registration gap analysis in global registration.