NMPA Medical Device and IVD Registration/Filing

      In accordance with the statutory procedures, all medical devices and IVDs have to be systematically evaluated in terms of its safety and effectiveness by China Food and Drug Administrations [CFDA for short, in September 2018, it was renamed NMPA (National Medical Products Administration)] according to the requirements of their registration application. After approval, these medical device products can come into Chinese market. In this process, applicants need to submit a complete set of application or filing documents for medical device registration so as to experts from NMPA conduct a comprehensive review for these documents.

      In China, any work related to medical devices is carried out in accordance with law. The highest law in the field of medical devices is “Regulations on Supervision and Administration of Medical Devices”.

      Japan, the United States, the European Union and other countries have different classifications for medical devices. The same product may have completely different classifications in different countries and regions. Before the official start of registration, determining the registration plan of a medical device is the most critical step in the preparation work. In this process, we need to clarify the classification of products, screen the applicable regulatory standards for products, decide the pathway of clinical evaluation and other important content, and select an appropriate legal agent in China. In addition, enterprises should also establish a good communication channel with the regulatory authorities of the target market, timely understand the registration progress and actively respond to supplementary comments and feedback on relevant issues in order to ensure the smooth registration of imported products.

Classification of Medical Devices

      Medical devices can be categorized into three classes based on their risk level and purpose of use. These categories are based on the “Classification Catalog of Medical Devices” laid down by the NMPA.

• Class I

Class I medical devices usually refer to low-risk class medical devices. It mainly includes some medical devices that are in vitro, inactive and in direct contact with human body, such as masks, general dental materials, and so on.

• Class II

Class II medical devices have medium-level risk. It mainly includes some medical devices that need to be tested and verified, such as electrocardiographs, X-ray machines, infusion pumps and so on.

• Class III

Class III medical devices have high-level risk. It mainly includes medical devices that perform invasive operations on human body, such as cardiac pacemakers, artificial joints, cerebral pacemakers and so on.

      Class I medical devices are subject to product filing management, while Class II and Class III medical devices are subject to product registration management. The research and development, registration, clinical trials, business sales, production, import and export of medical devices are also required to comply with detailed provisions of the corresponding laws and regulations.

Two Methods that Overseas Applicants Apply NMPA Medical Device Registration

• Your representative offices in China;
• Your enterprise legal person in China.

      Please contact us for more details.

Medical Device Consulting Service

      Our experts team works with NMPA on a daily basis, assisting our clients in submitting application documents, responding to supplementary questions form NMPA, and more. We believe that our experience, expertise, and communication channels can assist you in obtaining rapid regulatory approval for your medical device or IVD in China. Please contact us for more details about your medical device classification and product registration strategy in China.

NMPA Application Process of Medical Device Registration