A series of high-tech ingredients such as recombinant collagen, recombinant type 3 humanized collagen, sodium hyaluronate, recombinant mussel mucin, silicone, etc., have become the focus of many brands.
However, there is a significant difference between the contract production of medical devices and the OEM processing of traditional cosmetics, and brand owners face many challenges on the road to OEM production. To overcome this dilemma, brands can consider two strategies.
First of all, the brand can be authorized to the manufacturer who holds the medical device registration certificate and medical device production license. Although this method can enable the brand owner to obtain the qualification to operate, the disadvantages are difficult to avoid. On the one hand, in order to comply with regulatory requirements, manufacturers are often cautious about OEM. On the other hand, brand owners may encounter bottlenecks from the manufacturing side in the production and sales process, affecting operational efficiency.
Comparatively speaking, it is wiser for brands to apply to become medical device registrants. During the implementation, the brand entrusts the product to a qualified manufacturer for production, and with the help of the manufacturer's complete R&D data, it successfully obtains the "Medical Device Registration Certificate" under its own company's name. For the manufacturer, the order is obtained, and the scope and difficulty of supervision are reduced; For the brand side, it has absolute control over the brand and products, especially when applying for the medical device registration certificate, it can entrust multiple manufacturers to produce, so that the manufacturers can control each other and ensure that high-quality products are obtained at low cost.
This article is kindly provided by the medical device CDMO service provider - Dazihui Dazhi Dazi Pharmaceutical and Biological Industry Incubation Platform, **Please indicate the source!