e-Registration Submission System
NMPA plans to publicise the usage of its electronic Regulated Product Submission (eRPS) system. The eRPS system is an online submission system for medical device registration. Medical device manufacturers and legal agents are required to apply for a Certificate Authority for the eRPS system.
The registrant can apply for the CA certificate through the eRPS system. The certificate holder must be the domestic manufacturer of Class III medical device or the respective China agent of the imported medical devices of the foreign manufacturer. Each company is only required to apply for one CA certificate. Every CA certificate is valid for a year.
The eRPS system will be implemented on June 24, 2019. The certificate is essential for China agents to submit the registration application online.
Product Lifetime Evaluation of Active Medical Devices
NMPA implemented the "Guidelines for Lifetime Evaluation of Active Medical Devices" (hereinafter referred to as "Guidelines").
This guideline applies to active medical devices and will aid the medical device applicants in submitting registration documents for the lifetime of active medical devices.
‘Product lifetime’ refers to period from manufacturing date of the product to the expiration date. Before the registration of the medical device, the applicant has to ensure the safety and effectiveness through risk management. The expected time taken for this process is called the expected lifetime. Test verifications, comparable products and consistent experimental data on the components can be used to conclude the lifespan of the declared product. During the period of use, the applicant has to ensure the safety and effectiveness of the product. The QA/RA team must evaluate the risk and take appropriate measures when the product’s safety and effective performance is lowered to an unacceptable level.
The registrant has to follow the means provided in the guidelines to evaluate the expiration date of the product. Every component has to be evaluated and verified according to the respective clinical use situation. The registrant can refer to the template in the guidelines for the lifetime evaluation report and verification report.
Also, the information of repair and maintenance for the product has to be attached as a reference document
Qualification of Inspection and Testing Institutions
The China State Administration for Market Regulation (SAMR) issued a notification on the reform measures for the necessary qualifications of inspection and testing institution. This is to improve the qualification of inspection and testing institutions and to stimulate the examination market.
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