Recombinant humanized collagen for injection and filling has excellent filling effect and high safety performance, so it has broad application prospects in the fields of filling and tissue repair. In the face of huge market demand, can medical device registrant enterprises achieve the purpose of product listing through commissioned production?
Recombinant humanized collagen for injection and filling belongs to the "Injection Filler for Plastic Surgery" (2017 edition of the medical device category code 13-09-02), which is a Class III medical device used to fill and shape the human body. The Catalogue of Medical Devices Prohibited from Commissioned Production (No. 17 of 2022) issued by the State Food and Drug Administration clearly stipulates that the commissioned production of plastic injection fillers is prohibited.
It should be noted thatConsignment production is prohibitedRecombinant humanized collagen is already a fact that cannot be changed, butIt doesn't meanLosing the opportunity to enter the game, enterprises can also pass through independent productionImplementationPurpose
Although it is difficult to achieve independent production, enterprises can actively carry out outsourcing cooperation in the R&D stage, registration stage and production planning and construction process to improve efficiency and reduce investment. For example, skipping the R&D link of raw materials, obtaining R&D data by external procurement, and then completing the conversion of R&D data and obtaining the product registration certificate by outsourcing...
Throughout the implementation process, achieving mass production of the 100 schools of assistance plan is the top priority. From the early stage of construction to the acceptance, a large amount of resource investment is required to truly achieve independent production. If the company does not have the expertise or experience, the process is extremely difficult, and the cost of moving forward in the process of fumbling can become very expensive. The only way to control costs is to seek the help and support of professionals or third-party organizations to resolve conflicts and problems that the business cannot solve.
Finally, we conclude:Medical device registrant companies cannot achieve the purpose of listing recombinant humanized collagen for injection and filling through commissioned production, but they can seek itProfessionals orHelp from third-party agenciesRealize the planning of the plantwithConstructionand passed without a hitchAcceptance.
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