China service Registration in 10 steps

1. NDA

After we have signed the Non-disclosure Agreement, the device information will be gathered and protected.

2. Development of regulatory strategy

We develop a practical regulatory route specific for your devices. Including a detailed assessment report during the whole registration process. Also the timelines and costs per process step are included such as:

• Device classification
• The selection of the applicable test house
• Applicable national/industry standards
• Clinical route evaluation including the clinical study report assessment
• Predicate device approved in China search
• Cost and timeline estimation
• Full list of submission items and requirements to start the registration process 

3. Device Classification

Medical devices in China are classified in 3 groups, class I, II, III. Class I devices, whether imported or not, are not subject to registration procedures or technical review. Instead, such devices are notified with health authority with preliminary review, and may be granted approval on the spot.
Class II and Class III devices are still subject to standard registration procedures and technical review. We will help you to determine the correct classification route based on device characteristics.

4. Development of a Product Registration Standard

All devices in China need to have a dedicated test protocol, describing the test methodology, parameters and standards used to prove the product’s safety and performance. This document is called Product Technical Requirement (PTR), which will form the inputs for the test laboratory consultation and test implementation.

If mandatory to perform testing at the local laboratory, we will discuss with manufacturer and Qserve China has experts who can draft the Chinese PTR and present to the local test house. 

5. Product testing in China test laboratory

We will select and contact state recognized and qualified labs to test your devices of class II and class III. Class I products do not require local testing but submit manufacturer’s in-house test reports. We can help with the logistics and arrange paperwork for the clearance from the test samples by China customs, and deliver the samples to the test house when arrives locally in the mainland China.
Keeping frequent communication and good coordination with test house (Questions & Answers) is also key to smooth out the whole process to receive the local test reports in time. We will discuss with your in-house engineers, 3rd party test lab for pre-compliance testing, and support on rectifications of failed test items. When all the test items finish, a test report will be issued in Chinese.

6. Clinical assessment

Qserve China’s clinical team will help you to determine the clinical requirements for your device. It includes:

• Gap assessment on the current available clinical evidence from other markets
• Prepare cost overview
• Discuss the clinical strategy
• Coordinate the study set-up
• Pre-market clinical trial notification
• Selection of approved centers. Not all hospitals in China are allowed to perform clinical studies.
• CER drafting or selection of CRO

7. Clinical study

Qserve China’s clinical team work with local CRO partners and with Europe in-house based clinical team.

8. Registration

We will compile the registration file in line with authority requirements and doing the submission. It includes the facilitation of the registration process, and follow up until certificate is received. NMPA adopt comprehensive ERPS system and Table of Content structure. ERPS submission checklist for imported class II and class III device is provided on annex 2.

For Class II and Class III devices, the submission with NMPA involves both filing acceptance review and technical review. Both reviews may involve the requirement of clinical investigation if the product is not on the exemption list, and it also involves rounds of questions & answers via formal written notices or informal phone calls between the reviewer and applicants regarding the content of whole submitted documents. We will coordinate the complete registration process, and act as official representative of your company during the product life cycle. Any questions from the Center for Medical Device Evaluation (CMDE) will be organized by the China team directly. You will have direct communication with the Qserve China office, our project managers speak fluent both English and Chinese.

9. China Agent (Post Market)

Qserve China team is your regulatory agent for the post market phase. Once a license is granted, following obligations from the China Agent are required.  China agent's role is to support foreign legal manufacturer to perform the following obligations:

• Establish a quality management system (QMS) suitable for products and maintain effective operation
• Formulate post market research and risk management plan and ensure its effective implementation
• Carry out adverse event monitoring and reevaluation based on regulation
• Establish and implement product traceability and recall system
• Other obligations stipulated by NMPA under the State Council

10. Additional Services

Qserve China can provide additional services, including:

• NMPA overseas mock audit
• Audits of suppliers and contractors
• Distributor Search
• Translation support