Chinese Imported Medical Device Registration Certificate Agency Service
In line with the requirements of relevant documents from regulatory authorities, all imported medical devices must apply for registration with the China Food and Drug Administration (CFDA) to obtain medical device registration certificates. Given that many domestic and international clients are unfamiliar with document compilation and other requirements for registration in China, Guangzhou Panyue International Trade Co., Ltd. offers specialized medical device registration services. Our aim is to meet clients' needs and enhance service quality, and we have successfully assisted numerous enterprises in obtaining medical device registration certificates.
Upon receiving a client's registration request, Guangzhou Panyue International Trade Co., Ltd. will follow these procedures:
Evaluate and organize the technical documents, product materials, and certification information provided by clients.
Classify clients' entrusted products according to Chinese medical device regulations and the intended use of the products, and determine the specific application procedures.
Assist clients in translating import registration documents if necessary, translating required materials into Chinese as per the requirements of relevant national authorities. The time required depends on the language and volume of the documents.
Review product standards, define different registration standards based on product types, and assist clients in formulating corresponding registration product standards and completing standard filing (estimated time: 2 weeks).
Based on product categories, we will assist clients in contacting relevant testing centers approved by the food and drug administration for product registration testing. Different products will be sent to qualified national testing centers for inspection. The time and cost vary according to actual needs, and we will monitor the testing progress throughout the process and provide product technical rectification services.
For domestic and some imported medical devices that require clinical trials in China, we will assist clients in selecting medical institutions for clinical trials, formulating trial agreements and plans, and tracking the trial progress. According to national requirements, at least two hospitals are needed for clinical trials. The time and cost will depend on the cooperation agreements with hospitals and the statistical results of the products.
Determine the registration timeline based on product categories and the working days specified by the CFDA. Generally, it takes about 8 - 10 months for Class I products, 12 - 16 months for Class II products, and 18 - 24 months for Class III products. For special cases, technical communication services will be provided according to clients' actual needs.
Supplement necessary materials according to the information feedback requirements of relevant national authorities. When necessary, assist with the expert review of registered products and ultimately obtain the results of product import registration certification through technical review.
Obtain the final certification certificate and initiate free after-sales services, providing information on regulations, standards, and policies.
We stay updated with the latest information and policies on medical device registration from the National Medical Products Administration.
Our medical device registration team consists of professionals with extensive registration experience and in-depth knowledge of medical device registration regulations and technical requirements. The company has cooperative relationships with multiple universities and research institutes, enabling us to fully leverage relevant scientific and technological advantages to serve clients.
Once clients deliver the required samples and materials to us, we will handle the entire process, including material evaluation, translation, standard formulation, type inspection arrangement, clinical trials, trial process tracking, application material collation, submission, revision, and certificate acquisition, ensuring a worry-free experience for clients.
Class I: Medical devices whose safety and effectiveness can be ensured through routine management.
Class II: Medical devices for which safety and effectiveness need to be controlled.
Class III: Medical devices implanted into the human body, used to support or maintain life, posing potential risks to the human body, and whose safety and effectiveness must be strictly controlled.
One-on-One Service
Fast Processing Cycle
Twenty Years of Import & Export Experience
A Large Number of Successful Cases
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