The China Medical Device Registration Certificate refers to a certificate issued by the National Medical Products Administration (NMPA, formerly known as CFDA) indicating that the medical device product has been officially reviewed, meets the requirements of Chinese laws, regulations and standards, and can be sold and used in the Chinese market. This process is designed to ensure the safety, efficacy, and quality control of medical devices to protect consumer health.
Hotspot Engine Program Medical Device Classification.
In China, medical devices are divided into three categories, classified according to the risk of their use:
Category I: Low-risk equipment, such as conventional medical bandages and surgical gowns.
Class II: Medium-risk equipment such as X-ray machines and ultrasound machines.
Category III: High-risk devices such as pacemakers and prosthetic heart valves.
Registration Process. Pre-examination stage: The applicant shall first make a product classification judgment to confirm which class of medical device the product belongs to.
Preparation of application materials: According to the classification of medical devices, prepare corresponding registration application materials, including but not limited to product instructions, clinical evaluation reports, product technical requirements, production process descriptions, etc.
Submission of application: Submit all prepared registration materials to the Provincial Drug Administration (Class I) or the National Medical Products Administration (Class II and III).
Review Process: For Class II and Class III medical devices, the NMPA conducts a technical review and, if required, an on-site inspection. The review includes the product's safety, effectiveness, and quality control system.
Approval and issuance of a registration certificate: If the product meets all requirements, the NMPA will approve the registration application and issue a medical device registration certificate. For Class I medical devices, the provincial food and drug administration is responsible for record management.
Validity period of the registration certificate.
The medical device registration certificate is usually valid for 5 years. Before the expiration of the validity period, it is necessary to re-register in order to continue to sell and use in the Chinese market.
Importance. The medical device registration certificate is the key for medical device companies to enter the Chinese market. Without this certificate, no medical device product can be sold in China. Therefore, understanding the medical device registration process and requirements in China is essential for companies looking to sell their products in the Chinese market.
In addition, with the gradual alignment of regulations and international standards, the medical device registration process and requirements in China may change, and companies need to continue to pay attention to the latest policy developments to ensure compliance with all regulations and standards.