Class II medical device product registration technical review time limit is how many working days

Previously embarrassed by the long cycle of registration of Class II medical devices, the complicated process of the enterprise, you can now seize the opportunity. According to the new policy issued by Guangdong Province in May 2022, the technical review time limit for registration of Class II medical devices is compressed by an average of 50% compared with the statutory time limit, and in three cases, the system verification is only a data review, without on-site inspection. CIO Compliance Assurance Organization guides Guangdong Province enterprises on how to quickly complete the registration of Class II medical devices, and quickly to market.

One of the two types of medical device registration process

Upload electronic data, submit an application → acceptance (5 working days) → online technical review (not counted in the time limit) → organization of the registration of the quality system verification (not counted in the time limit of the approval) → decision (4 working days) → certificate (8 working days) → delivery (2 working days)

This is the first time that a medical device registration process has been completed in Guangdong Province. p>Two, the system verification only information review of the situation

Mainly include: 1. Annual quality credit A class production enterprises (hereinafter referred to as Class A enterprises) of the second class of medical device registration applications; 2. Within a year of the original production address through the verification of the system (including the third type of verification of the system), the application applies to the same production of quality management standard appendices (specifically) Appendix, such as the Appendix customized denture), or a classified directory of product categories and product types of the same system verification (product type refers to active, passive, sterile, customized denture, independent software, etc.); 3. Medical device change registration (excluding the need to carry out on-site verification of the ability to carry out self-testing and major changes in the production process and other circumstances that may affect the safety and effectiveness of medical devices).

Three, optimize the on-site inspection process

Improve the verification of the registration quality management system work procedures, parallel technical review and verification of the registration quality management system. Combined with the daily supervision of enterprises and quality credit, the combination of on-site inspection and data review, clear on-site inspection of the specific circumstances, to avoid duplication of inspection. Explore a combination of online and offline registration verification mode. For the submission of self-inspection report, in the system verification together with the verification of self-inspection capabilities.

Four, the implementation of the master file registration system

Gradually carry out the province's second class of medical devices master file registration, build the master file registration platform and database. The development of registration applicants to use the master file information guide, simplify the declaration of information, standardize the declaration of behavior. For the first registration, change the registration of the master file registration, the review department received a related medical device registration application, the master file information and review, to reduce the raw materials and key components of the repeated evaluation.

V. Simplify the approval of listed products

Support listed imported products and products outside the province to move into the province for registration. Overseas medical device registrants to wholly-owned, joint ventures or cooperation in our province set up enterprises, as well as cross-provincial mergers, reorganization or belong to the same group of provincial enterprises, the second class of medical device registration declaration, you can use the original product registration of the relevant reporting materials. The product classification is clear, clinical evaluation of evidence, the technical review of the product can only be implemented standards, inspection reports for review, in principle, the review time limit of no more than five working days, the quality management system verification time is counted.