Medical device product registration will be with production license | 'Unbind'

Medical Network August 23rd The author learned from the Provincial Food and Drug Administration that a few days ago, the State Drug Administration approved the "Guangdong Province Medical Device Registrar Pilot Work Program" (hereinafter referred to as the "Program"). In the future, applicants for medical device registration in the three pilot areas of Guangzhou, Shenzhen and Zhuhai may entrust Guangdong medical device manufacturers to produce products, allowing medical device R&D institutions and researchers to apply for medical device marketing approval, and explore medical device product registration and production. A breakthrough in the management model of the license 'unbundling' separation.

The reform measures for the 'medical device registrant system' in this Plan mainly include five items. First, applicants for medical device registration in the China (Guangdong) Pilot Free Trade Zone are allowed, as well as medical treatment in Guangzhou, Shenzhen, and Zhuhai. The applicant for the registration of the device can entrust the medical device manufacturer in Guangdong Province to produce the sample. It means that when the product is still in the 'incubation' stage, the applicant for medical device registration in the free trade zone is allowed to commission the production, regardless of whether the sample enters the special medical device for approval. program.

At the same time, the registrant is allowed to produce or entrust other enterprises to produce medical equipment on their own. After obtaining the registration certificate, if the registrant has the corresponding production capacity, it can produce it after the medical device production license; if the registrant does not have the corresponding production capacity, Entrust other enterprises to produce, and handle the relevant procedures for entrusted production. If the trustee does not have the corresponding production qualification, the registrant's medical device registration certificate can be submitted for production license.

In the sales process, the “Proposal” proposes that the registrant can sell the medical device by himself, without having to apply for a medical device business license or filing, or entrust a medical device operating enterprise with the corresponding conditions to sell the medical device. If the medical device is commissioned for sale, the registrant should Responsible for the quality of the medical equipment that is entrusted to be sold, sign an entrustment agreement with the entrusted business enterprise, clarify the rights, obligations and responsibilities of both parties, and strengthen the management of the entrusted business operations to ensure that they are sold according to legal requirements.

For existing medical device manufacturers that already hold registration certificates, registration and production 'peeling' can be achieved. The “Proposal” proposes that the province has obtained medical instruments Registration of medical device production enterprise , can be implemented in accordance with the relevant provisions of the "Program".

In addition, the group company is encouraged to become a registrant. The medical device manufacturing enterprise group company can concentrate the medical device registration certificates of each holding subsidiary to the group company. The group company integrates and integrates the products according to the production and processing capabilities of each holding subsidiary. Each subsidiary has become a characteristic, advantageous, and large-scale production base. The group company implements a unified quality management system for each subsidiary, and the group company product quality Take full responsibility.

According to the person in charge of the Provincial Food and Drug Administration, the pilot reforms in the “Program” will help strengthen the registrant's life cycle responsibilities, encourage innovative R&D and continuous improvement of quality, and further promote research. Talent , R & D institutions and innovative companies gather to optimize the market allocation of innovative resources; at the same time, it is conducive to speeding up the listing of medical devices to meet the increasingly urgent quality of the public health service requirements.