February 14, 2020

Qualtech Consulting Corporation is honored to have helped one of our Korean customers to get access to the Chinese oral surgery market. Qualtech assisted in all registration stages, which included our service of planning the product pre-market strategy, conducting type testing, clinical trials, GCP inspection, medical writing, and the registration itself. Ultimately having led to a smooth approval in China in December 2019.


Focusing on the Case:

High-risk and animal-derived implantable products need to be evaluated in a variety of aspects; including among other items, immunization, viruses, animal origin, animal clinical trials, and human clinical trials. With the extensive experience in implantable products, Qualtech customized the product registration strategy, and had set up an expert team to work closely with the customer's R&D department. In addition, Qualtech conducted research and thoroughly analyzed NMPA’s requirements and the differences between the regulations in China and the ones applicable internationally. Furthermore, we assisted the client to comply with the registration guidelines and the preparation of the product dossiers to meet the Chinese NMPA’s requirements.

Qualtech has achieved a breakthrough in the area of implantable and high-risk devices, especially regarding animal-derived products. We possess a team composed of internal and external experts, as well as a comprehensive pre-market regulatory service, and strive to assist customers to overcome any challenges a registration in China may bring.

List of QT Regulatory Services:


QT Services:

A. Planning

✦ Classification assessment

✦China standards/guidelines assessment

✦Clinical pathway assessment

✦Similar product evaluation

✦Product registration strategy

B. Type testing

✦Product technical requirements

✦Preparation of test application

✦Specialist communication

✦Follow-up on the type testing records

✦Product rectification discussion*

C. Clinical evidence

✦Clinical evidence assessment search

✦Similar product study

✦Clinical Evaluation Report Writing Services*

✦Animal Clinical Trials Services*

✦Human Clinical Trial Services*

D. Registration Dossiers

✦Dossier templates complying with the latest regulatory requirements

✦Personal specialist consultation service

✦Medical Writing Services*

✦Internal project management system

E. Review and Compliance

✦Reviewing the response strategy

✦Advisory meeting of external experts*

✦Full provision of the registration dossiers

F. Other

✦Translation Services*

✦Special Testing Reporting Service*

✦NMPA Expert Panel Service*

✦Product import and export services*

* The asterisks indicate the special items provided for the specific purpose of this project.

Is your company also interested in the Chinese market? We welcome you to contact us and to obtain a customized product pre-market strategy plan.