How to conduct medical devices registration in China in cost-effective way

How to conduct medical devices registration in China in cost-effective way
Under the revised version (Decree No. 650) of the Regulations for the Supervision and Administration of Medical Devices in China that came into force on 1^st June 2014 with its related measures and provisions for medical device registration that implemented on 1^st October 2014. All medical devices or in vitro diagnostic regents (IVDs) should be subjected to China Food and Drug Administration (CFDA) under the new submission process and approval requirements. There are different data requirements depending on the risk-base classification and types of devices.
The increasing risk level (classification) and complexity of data (safety, biocompatibility and clinical data) that must be submitted to CFDA has no doubt imposed great burdens on companies striving for compliance. Therefore the purpose of this article is to share some experiences regarding cost analysis and how to conduct medical devices registration in a cost-effective way and also reduce the regulatory burdens of this law for the medical device industry.

The composition of registration costs
Normally the total cost for the registration of medical device in China consists of four parts:

Registration Costs	Estimated Cost (In general) RMB
	Class I medical devices	Class II medical devices	Class III medical devices
Testing Fee	-	20,000-100,000	40,000-300,000
Clinical Trials Fee	-	Waiver: 0 Or, 150,000+	Waiver: 0 Or, 200,000+
Administrative Fee	-	TBA	TBA
Consulting Fee	20,000-50,000	60,000+	80,000+
Grand Total	20,000-50,000	230,000+	320,000+

The above chart is for reference purposes only. It does not represent actual cost composition.

Testing Fee: The registrant must appoint a qualified laboratory ratified by CFDA to carry out necessary tests to meet the product technical requirements under the legislation.

Clinical Trials Fee: The class II and III medical devices are required to conduct the clinical trials in China when it is not listed on the clinical trial exemption list. This clinical trials fee usually represents the major part of total costs, especially when it comes to higher-risk devices registration (e.g. implanted medical devices registration).

Consulting Fee: For foreign companies planning to introduce medical device or IVDs into China, they may appoint a competent local agent to handle the medical device registration and fulfill the regulatory obligations under the legislation.

Administrative Fee: Currently the CFDA are not charging administrative fees from companies for medical device’s evaluation and registration. However, the company shall pay administrative fee once administrative fee required by CFDA.

How to conduct the registration in cost-effective way

• Choose the appreciate classification

The medical device classified into three levels: class I, II and III. The applicant is advised to determine the appropriate classification, as the registration cost for different classes of medical device varies greatly.
For initial registration for class I medical devices, it is wise for the applicant to acquire test report and clinical data by themselves or using the existing data to save costs.
For class II and III medical devices, the biocompatibility test for material of medical devices can be available from material supplier or using the exiting report (ratified in advance) to save costs. And the applicant can apply for clinical trial exemption to save costs if the medical device meets the exemption requirements.
It is increased data requirement depending on its classification.

• Confirm the registration unit

There is one certificate for one registration unit. The registration unit can be confirmed by comparing the intended purpose, structural characteristics, method of use, and other relevant factors with the similar products. If the similar devices or components successfully fall into one registration unit with different model, there will be required only one test report, clinical study report and one dossier to apply for medical device registration. It will be great help to save registration costs and time.

• Formulate testing strategy

In general, the test report should be conducted in Chinese qualified laboratory for class II and class III medical device, however, some biocompatibility test report for material of medical devices can use the exiting report (ratified in advance) to save costs.
For contacting medical devices, there will be required to conduct safety test and biological evaluation, it is mandatory to submit the safety test report conducted according to the product technical requirement before clinical study, and generally, the biological evaluation would be taken much longer than the safety test. So we recommend to applying for different issues for product safety test and biological evaluation, it will save much more time in the registration process.
There are different quotations and duration from different laboratories, so we need to negotiate with each laboratory before conducting the test in China.

• Develop the appreciate clinical study strategy

In certain situations, class II and III devices may be exempted from clinical trial requirements, or be allowed to undergo modified trials. The medical device registrant may be allowed to use clinical evidence reports to reduce the size of, or eliminate, clinical trials.
The clinical trials are not required when the medical device listed on the catalogue of medical device exempted from clinical trial in China.

• Prepare the required documents with English or Chinese version

The all documents submitted to CFDA are required to prepare in Chinese or with translated version. The product technical files can be prepared in English or Chinese initially. It will save costs and time to translate the materials.

Foreign device manufacturers need to understand that medical device registration is costs and time consuming, it is the important stage to introduce the overseas medical into China. Conducting medical device registration in cost-effective way would be great helpful for your successfully trading in China.