According to the "Regulations for the Supervision and Administration of Medical Devices", the validity period of the registration certificate for medical devices should be 5, 10 or 15 years in principle. Among them, the validity period of the registration certificate for Class I (high-risk) medical devices and Class II (higher-risk) medical devices is 5 years; the validity period of the registration certificate for Class III (medium-risk) medical devices is 10 years; and the validity period of the registration certificate for Class IV (lower-risk) medical devices and household medical devices is 15 years. However, the specific validity period also needs to be determined according to different medical device classification regulations and actual situation. For example, for some specific high-risk medical devices, annual renewal of the registration certificate may be required; while the validity period of the registration certificate for some low-risk medical devices may be extended to 20 years. In addition, after the expiration of the validity of the medical device registration certificate, it is necessary to reapply for the registration certificate or carry out procedures such as change or renewal. If the procedures are not carried out on time, the device may be recognized as "expired device", affecting its further sales and use in the market.
Is it necessary to re-apply for a registration certificate after the expiration date of the medical device registration certificate? After the expiration of the medical device registration certificate needs to be changed, updated or renewed accordingly. The specific need for which procedures, should be determined according to the actual situation and laws and regulations. For example, for some low-risk medical devices, the validity of the registration certificate can be extended to 20 years without the need to reapply for the registration certificate. However, if the validity of the registration certificate expires without timely processing of the relevant procedures, it may have an impact on the sales and use of the medical device in the market.
The validity period of the registration certificate of medical devices is one of the important measures to ensure the safety and effectiveness of medical devices. Each manufacturer and operator should strictly observe the validity period of the registration certificate in accordance with the relevant regulations, and apply for renewal, change and other procedures in a timely manner to ensure the legitimacy and safety of their medical devices in the market.
Legal basis:
"Chinese People's Republic of China **** and the supervision and management of the production of medical devices," Article XIII "Medical Device Manufacturing License" is valid for five years, set out the license number, the name of the enterprise, the legal representative, the person in charge of the enterprise, the residence, the production address, the scope of production, the issuance of licensing department, the date of issuance and the validity of the period of time and other matters.