I. Definition and use of prototype
Medical device prototype usually refers to the model or prototype made to show the product appearance, function or performance test before the product is formally produced. It is mainly used for internal research and development, testing, demonstration and providing reference to potential partners or customers.
The restrictions and regulations on the sale of prototypes
Since the prototype is not the final product, its safety, efficacy and compliance may not have been fully verified, so the sale of prototypes is subject to certain restrictions. According to the Regulations for the Supervision and Administration of Medical Devices and other relevant laws and regulations, the sale of medical devices must comply with national standards and pass the corresponding registration or filing procedures. For prototypes, due to their special nature, direct sales to end users are usually not allowed.
Three, the legal sales channels and requirements
If the company wants to sell medical device prototypes, it needs to make sure that the prototype meets the requirements of relevant laws and regulations, and is sold through legal channels. This usually involves signing a clear agreement with the potential buyer that specifies the use of the prototype, the limitations, and the liability attributed to the prototype. At the same time, the company also needs to comply with relevant intellectual property protection regulations to ensure that the technical and commercial secrets of the prototype are not disclosed.
Four, the prototype of other ways to deal with
In addition to sales, enterprises can also consider other ways to deal with the prototype, such as as internal R & D materials to save, for teaching or training purposes, donated to scientific research institutions or medical institutions for further research. These methods not only meet the requirements of laws and regulations, but also give full play to the value of the prototype.
In summary:
Prototypes in the medical device industry are subject to certain restrictions and regulations on sales. Companies need to comply with the requirements of relevant laws and regulations to ensure the legality and safety of the prototype. If they wish to sell prototypes, they need to do so through legal channels and sign clear agreements with potential purchasers. In addition, companies may consider other ways to dispose of prototypes in order to fully realize their value.
Legal basis:
"Regulations for the Supervision and Administration of Medical Devices"
Article 7 states:
Medical device products should comply with the mandatory national standards for medical devices; where there are no mandatory national standards, they should comply with the mandatory industry standards for medical devices.
Methods for the Administration of Medical Device Registration
Article 8:
Application for registration or for the record of imported medical devices should be in the applicant's place of registration or production address in the country (region) has been approved for sale.
The applicant shall be responsible for the authenticity and legality of its application for registration or for the filing of the medical device in China's territory of the development, production and business activities.