April 9th, 2018
Medical device regulations in China have changed frequently in the recent years, such as updating of multiple national standard andindustry standards, issuing of product guidance and administrative directives. With its 10-year experience in China's active medical device registration, Qualtech would like to share an overview of the common roadblocks of the registration process a foreign manufacturer frequently encounters. These can be summed up into six main points, and are further explained in the paragraphs that follow. At the same time, we have also provided relevant suggestions with respect to these issues we have identified.
In this article, we won’t talk about the basic information of registration process in China. If you would like to understand this basic information, kindly click on this link. We hope to help our customers understand the current status of China's registration process and decrease the difficulties in the process of registration.
[Type testing part]
a. For active medical devices, the registered device needs to be tested in the official testing center in China. When we send the device for testing, we can choose either of the two testing routes: one is “registration type” which is a free service, while the other is the “entrust type”, which requires the applicant to pay for the testing fee. The manufacturer shall inform the testing center which type they plan to apply for. Another difference between these two types is the CFDA acceptance. Previously, CFDA only accepts type testing report released via registration type. However, CFDA released new set of rules regarding type testing last January 2018, which states that currently, CFDA could accept type testing reports via entrust test. In general, all testing centers should focus on the entrust type, and not on the registration-type test.
[Interpretation] After the new notice was released, most testing centers started to focus on the entrust type, but in some testing centers, the registration type is still followed. We suggest the applicant to consider taking the “entrust type” as this route is faster compared with the registration type.
b. There is a unique test which only exists in China, called the environment test (GB/T 14710-2009). The environment test is applicable only to some active medical device for verifying the ability of the product to withstand different environmental conditions, such as working, storage, and transport conditions. The testing procedure involves storing the device at low/high temperatures, as well as subjecting it at high/low temperature operating conditions. Other tests, including vibration and collision test are required in GB/T 14710-2009. The applicant could easily recognize whether the environment test is applicable to the product based on the relevant national standard and product guidance.
[Interpretation] The testing parameter of the environment test is set up based on the device specification. We suggest the manufacturer to make an effort to understand the devices’ operating environment and take it into consideration during the product development stage. It’s beneficial for accessing the China market.
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c. If the manufacturer's active device products are expected to apply for multiple models in China, all models need to be tested for the electromagnetic compatibility (EMC) as per current regulation. Many of Qualtech’s clients would like to know whether it is possible to select the representative model to conduct the EMC test. According to the recommendations provided by the Center for Medical Device Evaluation (CMDE), manufacturer shall send all models to testing lab for testing if the manufacturer plans to apply for all models in one license. The testing center would evaluate all models and decide the appropriate model for inspection. The appropriate model might either be only one model or all models. Moreover, it’s required to mention the product information of all models and representative model in the EMC report.
[Interpretation] The testing center would evaluate and select the representative model based on the product and the information provided from the manufacturer. We suggest the manufacturer to evaluate the differences of the performance characteristics of each model in advance. If there are any differences among the models, it would be highly possible to perform EMC test for all models.
d. Regarding the acceptance of the electrical safety test and the IEC60601-1 report, CMDE only accepts test reports which are based on the 2nd edition of IEC60601-1 All active medical devices have to undergo electrical safety test based on the GB 9706.1 during the registration. The internal test procedures to be conducted in the testing centers would be different when the applicant provides test reports based on either 2nd or 3rd edition of IEC60601-1. If the applicant provide reports based on the 2nd edition, testing center will not include some test procedures. But if applicant reports based on 3rd edition, they will perform all electrical safety tests covered in the said edition.
[Interpretation] Manufacturers are requested to follow the IEC60601-1 report. If 2nd edition of the IEC60601-1 report is used, some of tests are exempted. If it is the 3rd edition of the IEC60601-1 that is used, however, we suggest the applicant perform all tests of GB9706.1-2007 directly in China.
[Submission document part]
e. If there are similar products listed in China, the applicant may submit clinical evaluation report (CER) via the equivalence comparison pathway. When choosing the equivalence comparison pathway, the applicant shall obtain the authorization letter of the predicated device from the relevant manufacturer. The manufacturer shall refer to the guidance of the clinical evaluation report, which was released in 2015 by the CFDA, and prepare the CER. The CER should contain explanation of all differences in the composition, structure, and performance of the products. Clinical evidence should also be included in the CER.
[Interpretation] The source of clinical data shall be based from the clinical data generated from your own products with the same model and parameter. The applicant may provide the overseas clinical data, such as the post-market surveillance report (PMS), and the Post-Marketing Clinical Follow-up (PMCF) studies. For the predicated device, CFDA will ask the applicant to provide the authorization letter. In general, it’s hard to obtain the authorization letter from other manufacturer. Therefore, if the applicant already has similar product registered in China, then the equivalence comparison pathway would be suitable. If not, then the equivalence comparison pathway would not seem to be a good idea.
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f. Manufacturers need to provide the core algorithms when preparing software documentation for active devices. However, Manufacturers often don’t understand what core algorithm is. According to the Medical Device Software Registration Technical Review Guidelines issued by the CFDA, “the core algorithm” refers to the algorithms used to implement the main functions of the software (the main functions means the functions that can achieve the intended use of the product). The manufacturer may provide the core algorithms via imaging algorithms, post-processing algorithms, and artificial intelligence algorithms. Core algorithms come in 2 types: (1) well-developed, where the working principles are clearly understood and therefore, no further post-market advertisements required; and (2) innovative, which are novel approaches that require extensive research.
[Interpretation] Many manufacturers are reluctant to provide core algorithms, but the core algorithm is a necessary information. Manufacturers can provide appropriate algorithms and relevant descriptions based on the core performance of their own products for CFDA reviewer’s reference.