Ensure your non-sterile, non-measuring medical devices gain Class I medical device filing to enter the Chinese market. Our remote team manages the entire NMPA notification and Chinese label review process, keeping your products compliant with China's medical device regulations.
📋 Request Free Class I Filing ConsultationClass I medical device filing (also referred to as NMPA notification for general medical devices) is the mandatory record-keeping procedure for imported non-sterile, non-measuring medical devices that fall under the lowest risk classification in China. Devices like examination gloves, stethoscopes, manual wheelchairs, or surgical masks typically belong to this category. Instead of a full registration certificate, manufacturers must complete an electronic medical device filing with the National Medical Products Administration (NMPA) before the products can be legally sold or distributed in the Chinese market.
Our Class I medical device filing service guides foreign device manufacturers through the entire China NMPA notification journey. We assist with product classification verification, prepare the Chinese label and instructions for use, and submit the filing dossier on your behalf. With our support, you can navigate the imported medical device filing requirements without a local office.
We confirm that your product meets the criteria for Class I medical device under the NMPA Medical Device Classification Catalog and is not subject to special requirements (e.g., sterile or measuring functions).
We compile the required technical file, including product description, intended use, manufacturing process, and Chinese label and IFU according to NMPA guidelines.
We submit the complete dossier through the NMPA's online medical device registration system, ensuring all product information, manufacturer qualifications, and safety documents are correctly uploaded.
Once accepted, you receive the Class I medical device filing notification. The filing is valid permanently, and we can assist with updates if product specifications or manufacturer information change.
Any non-sterile, non-measuring, non-active medical device that is listed in the NMPA Class I catalog can be placed on the market via filing rather than full registration. Typical examples include:
If your device is sterile or has a measuring function, it may require a Class II or III registration instead. Contact us with your product specifications for a free medical device classification check.
To apply for Class I medical device filing, foreign manufacturers need to prepare the following (we provide translation and document preparation support):
The typical Class I medical device filing process takes 4 to 8 weeks from document preparation to notification acceptance, depending on product complexity and NMPA review queues. Products with complete technical documentation may be filed within a shorter time frame.
Cost factors include document preparation, translation services, and professional service fees. We provide a fixed-price proposal after evaluating your device — no hidden fees.
Several new product categories have been added to the Class I classification list, making it easier for manufacturers of general medical devices to enter the Chinese market through the filing route.
NMPA has clarified font size, language, and information placement requirements for medical device labels. Ensure your packaging complies with the latest standards.
Incomplete product descriptions and missing manufacturer qualifications are common causes of rejection. Follow our checklist to ensure a smooth NMPA notification.
Get in touch with our team for inquiries, quotes, or more information about Class I medical device filing
Have questions about Class I medical device filing, NMPA notification, or medical device labeling in China? Our experts are here to help with any inquiries about product classification, document preparation, or custom solutions for your general medical devices.