Medical Devices
In China, all medical devices and products should comply with the mandatory standards of the state for medical devices. An overseas enterprise is required to register an application and the marketability certificates issued by state/local authority submitted by their representative office or legal representative in China to the Food and Drug Administration Department of the State Council.
The registration timeline depends on the functions and product complexity that will determine the necessary procedures to be applied for the particular categories. Knudsen&CRC is prepared to support you in all aspects of the certification and registration process. Our team is will help you review, guide, and identify applicable information and specifications required.
We Offer These Services for Medical Devices
Preliminary Product Evaluation
When entering the market in China, it is the responsibility of foreign companies to know the authorizations and regulations. Before initiating importation, it is essential to ensure all product ingredients and content levels are approved in China. In case of failure in submitting proper product notification and registration, parties involved may face financial and criminal penalty. Knudsen&CRC can provide you with a detailed overview of product compliance, categorization (Class I, II, or II), and regulatory framework. Our team is prepared to assist in the process of screening medical devices’ labeling instructions for use, determining compliance, and indicating specification qualification items (i.e., manufacturing enterprise information, maintenance methods).
NMPA Filing/ Registration
Knudsen&CRC can provide you with a detailed overview of product compliance, categorization (Class I, II, or II), and regulatory framework. Our team is prepared to assist in the process of screening medical devices’ labeling instructions for use, determining compliance, and indicating specification qualification items (i.e., manufacturing enterprise information, maintenance methods).
Includes
Application Dossier Preparation
Ingredient & Packaging Consulting
Documentation Submission
Sample Test Preparation
Frequently Asked Questions
Medical devices refer to apparatus, equipment, instruments, in vitro diagnostic reagents, materials or other objects used directly or indirectly with the human body, including necessary computer software. Their effects are achieved mainly by physical means and cannot be obtained by any pharmacological, immunological or metabolic means.
Medical Device Objectives :
- Prevention, diagnosis, treatment, monitoring, and mitigation of disease
- Diagnosis, treatment, monitoring, mitigation and functional compensation of injury or disability
- Research, substitution, adjustment, or support of anatomical structure or physiological processes
- Support of sustainment of life
- Gestation control
- Provide information for medical treatment or diagnosis through examination of samples from the human body
Product categories are as follows:
Class I – Medical devices with lower risks; their safety and effectiveness can be guaranteed by implementing general management
Class II – Medical devices with moderate risk; their safety and effectiveness can be guaranteed by implementing stricter management
Class III – Medical devices with higher risks; their safety and effectiveness can be guaranteed by taking special measures and by stricter management
NOTE: Class I medical devices require record-filing by municipal NMPA. Class II and III require provincial and state NMPA registration, respectively.