What are the common Class II and Class III medical devices in China?
It is common to see that the classification system in China is stricter than that in Europe or in the US.
There are some general including criteria for Class III device:
- Any implant device is class III.
- Any absorbable device is class III.
- Any device with ancillary medicinal substance is class III.
- Any non-active device with body contact used in long-term (more than 3o days continuously) is class III.
There are some general including criteria for Class II device and above:
- Any sterile device is class II or above.
- Any device with measurement function is class II or above.
- Any software as medical device (SaMD) is class II or above.
To check the class of a device, the manufacturer can reference the current Category List or the predicates in the database of NMPA website (only available in Chinese).
How is the Class II and Class III device registration done in China?
The imported device must be registered in the home country (except for innovative device, to see more information, please see our information page: Green Channel Registration Process for Innovative Devices.)
The manufacturer shall have a Chinese company or a rep office in China to act as a China agent to communicate with the NMPA. You may use the legal representative service of JMEDTEC in China, if needed.
Ensure the device is class II by using the reference in the Category List or the result of classification determination process.
The product technical specifications of every imported device must tested in a NMPA-accredited testing lab in China. The product technical specifications shall be written in such a file called Product Technical Requirements (PTR), in which the technical specifications of the device, the applicable standards (Chinese standards if there is any applicable) and the test method are described.
The testing lab using the PTR to perform the tests with product samples shipped to China. After the test, a testing report is released, which is then included in the registration dossier.
As the limited number of NMPA-accredited labs, the waiting time is usually long. The manufacturer shall plan about 4-6 months for lab testing and report release.
For active devices, please note the electrical safety and EMC tests must be redone in China. Although the standards are generally the same between those used in China and the international standards, the test process can be very challenging due to the different interpretation of the standards by the Chinese technicians.
JMedTec has gathered a list for all the Chinese standards in the medical device field and the international equivalence (link).
The biocompatibility tests are not required to be repeated in Chinese lab if the tests were done abroad in a GLP-accredited lab. However, it is often see that the NMPA requires more endpoints in biocompatibility tests, especially the long-term ones. If those tests are not done before, the manufacturer may have to add those tests, which then take additional time.
For some products, the NMPA has released a guideline for the technical specifications and the endpoints of biocompatibility tests, please reference the list of guidelines for a certain device (link) gathered by JMEDTEC.
Clinical Evaluation is a very important and complex topic among the registration requirements.
The available pathways for clinical evaluation are as follows:
- Exemption: If a device is in the exemption list, the manufacturer can submit a clinical evaluation report (CER) in a simple template format given by the NMPA.
- CER-only approach: If a predicate in the Chinese market is available and the manufacturer has collected good trial data in the regions of EU, US and Asian regions, a clinical evaluation report can be submitted. The data required in the report is not a translation of the EU CER but must be done according to the NMPA requirements.
- CER plus validation study: If the overseas clinical trial data represented in the CER in option 2 is not solid enough to show the safety and effectiveness of the device, a local validation study in Chinese cohort can be added to convince the reviewer without running full parallel controlled study.
- Full trial in China: if no predicate is available in China or no overseas trial has been performed, the manufacturer has no other choice but conduct a clinical trial in China.
Timeline:
The CER can be drafted in paralleling with the lab testing, so no additional time is required.
If a clinical trial shall be performed in China, the trial can not start before receiving the testing report, as the report shall be included in the IRB submission dossier. The time is then highly dependent on the trial design.
The following dossier for registration process is required in the format provided by the NMPA:
- Application form
- Business license of the manufacturer and the home-country approval
- Essential requirement list for device safety and effectiveness
- Summary data
- Research data
- Manufacturing Information
- Clinical evaluation
- Risk analysis data
- Product technical requirements (PTR)
- Testing report
- Draft IFU and label
- Declaration of conformity
After the dossier submission, the administrative office of the NMPA will check the format and content of the dossier, which takes usually 5 working days to give a feedback.
If everything is ok, the NMPA informs the manufacturer to pay the review fee:
Class II: 210,900 RMB (ca. 30, 000 USD); Class III: 308,800 RMB (ca. 44,000 USD).
The technical review starts after the payment is confirmed by the NMPA: Class II, 30 working days; Class III, 45 working days.
The deficiency letter is issued after the first review. The manufacturer has then 1 year and one-chance only to reply to the deficiency letter.
By submitting additional data, the manufacturer can reply to the NMPA for the second review, which takes 30 working days. If the data is accepted, the NMPA shall start the final process of releasing a certificate, which takes 30 working days. If the data is not sufficient, the NMPA informs the manufacturer to either 1) withdraw the submission, the dossier is then returned back to the manufacturer and the review fee is not refunded, or 2) release a rejection note and the dossier is archived.
If we count 6 months for replying the deficiency letter, the whole review process would take 13.5 months for class II and 15 months for class III.
Plan the budget for Class II and Class III device registration
The followings costs shall be considered for product registration:
- Lab testing costs for technical specifications
- Lab testing costs for biocompatibility tests if any required
- Lab testing costs for electrical safety and EMC for active device
- NMPA review fee: Class II: 210,900 RMB (ca. 30, 000 USD); Class III: 308,800 RMB (ca. 44,000 USD).
- RA submission services
- Medical writing for CER in NMPA format or clinical trial cost
- Dossier translation cost
- China Agent service fee if no local China rep office
- Cost for product samples used in lab testing or clinical trials
Main challenges for Class II and Class III device registration
The China registration process is very time-consuming and the regulations change rapidly. It is crucial to develop a good registration strategy to balance the regulatory requirements and the working process for a successful registration. The strategy should also be flexiable to align with the regulation changes.
Lot of work in registration can be done in parallel. The manufacturer shall be aware of the right process and order to organize the work correctly. A good project management would save lots of time and efforts during the registration.
China registration must involve the lab testing in a local lab with Chinese-speaking only technicians. It is very important to have a well English and Chinese speaking technical professional to communicate the testing issues with the lab technician. This person is not a simple interpreter but understand the standards and technical details well to discuss the technical issues.
The close communication with the reviewer is very important. The consulting chance to the reviewer is very limited and the answer that manufacturer gets from the reviewer is usually very diplomatic. How to ask the right questions and to understand the words between lines is very crucial to provide the right information during the review.
Why choose JMedTec to assist you with the Class II and Class III device registration?
JMedTec has a professional RA team with 10-20 years industry experiences in medical devices, all of them have worked as RA global manufacturer companies before joining JMedTec.
We are not only familiar with the detailed regulatory requirements but also have the insight of the trend of regulation updates. So we can develop the best strategy and work to reach a successful registration.
By having broad network and connections with the testing labs, we can schedule the testing plan timely and interpret the technical requirements precisely of the technician to accelerate the testing process.
We know how to tailor the application dossier best to the regulation requirements. Our RAs are very experienced in justifying the data with the reviewers. JMedTec has a very good reputation in the industry to provide the quality work.
Please contact us for further help at info@jmedtec.cn.