Registration, Renewal, Modification.
Depending on where you plan to sell your device(s), successful registration may involve substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.
China Med Device can assist you in registering your medical device products. Our regulatory consultants are diligent in preparing and reviewing medical device registration documents. We will take the following steps to minimize additional documentation requests from the approval body and other delays:
Face-to-face Consultation with NMPA Reviewer
Do you need assistance in NMPA (CFDA) consultation before initiating your registration? In the areas where it is not clearly defined, it is better to double-check your registration questions and strategies with NMPA during your pre-submission phase. With a team of bilingual seasoned staff located in our Beijing office, down the street from the national NMPA office, China Med Device, LLC is well-positioned to provide NMPA Onsite Consultation service to overseas medical devices & IVD manufacturers. In addition, as an NMPA certified legal agent, we can represent overseas companies.
China Med Device, LLC can help you research and prepare the questions, and get feedback from NMPA reviewers. You can ask questions related to the registration process ranging from registration category, pathway strategy, technical standards and local type testing, clinical trial endpoint, overseas clinical data, etc. China Med Device, LLC will schedule an appointment, submit questions, and obtain feedback.
Type Testing Support
When registering your products, local type testing is required to be done in China, The whole registration timeline will also be impacted by test duration.
Local type testing could take a long time and be frustrating. We have onsite test engineers at the NMPA testing centers to support and facilitate the tests between the NMPA testing center engineers and the reviewers. We have an extensive technical background to handle difficulties for our clients. Our Testing Director has more than 10 years of experience in NMPA registration, type testing, and technical troubleshooting. He has complete knowledge in IEC standards and China GB & YY standards.
After reviewing the product information, we will draft a PTR (product technical requirement) for type testing, including all standards and test methods applicable to your device. We will help you select a certified China test center for your type testing and offer onsite support to achieve your goal of passing type testing.
Registration, Renewal & Modification
The product registration requirements and process in China can be really different from the US and EU. China Med Device has successfully obtained 1000+ China NMPA certificates for our client. Our integrated regulatory, technical, and clinical team can help you prepare required documents, give on-site type testing support, provide full CRO service to accelerate your process for registering your product in China.
NMPA Renewal application must be submitted 6 months prior to the certificate expiration date for no change renewal. NMPA is very strict about their rules and regulations. We are a certified CFDA legal agent in China and have helped many clients with their renewals, modifications, or new applications.
Fast-track Pathway: Innovation, Priority and Emergency
Three fast-track Channels have been established by NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval.
Innovative Device Status is established by NMPA to encourage innovation and bring innovative technology to China: Being granted status can significantly shorten the time for market introduction. If the “Innovation Device Status” is granted (which does not mean “approval”), the device will be allocated ‘front-of-queue’ priority throughout the registration process. The granted priority affects the classification determination, pre-clinical testing, QMS auditing, and CFDA reviewing/approving processes. Meanwhile, a specially-assigned NMPA officer would check in and provide needed guidance throughout the whole expedited process.
For Priority Review, applicants have to meet one of the following scenarios:
- Treat rare diseases with significant clinical application value,
- Diagnose or treat malignant tumors with significant clinical application value,
- Diagnose or treat geriatric diseases, which no currently have effective diagnosis or treatment
- Be intended for pediatric diseases with significant clinical application value,
- Be intended for unmet medical needs, which currently have no effective diagnosis or treatment, or
- Be listed in National Science and Technology Major Projects or National Key R & D Plans
For Emergency Approval, have to meet one of the following scenarios:
- Be intended for public health crises, which currently have no effective product, or
- Be intended for unmet medical needs