For the medical devices on the market of China, they have to accept the full lifecycle supervision from food and drug administration. Also the second and third class medical devices need approval from the food and drug administration. The supervision department shall systematically evaluate the safety and effectiveness of the medical devices, and then decide whether they can be the sale or used. Medical device companies may need registration services from rockacola, including writing product technical requirements, product testing, composing and reviewing registration materials, and declaration.
rockacola has a professional registration team, more than 53.8% team members incept master degree or above. They were divided into different groups based on active, passive and IVD and owned Extensive experience on second and third class medical device product registration Such as artificial organs, orthopedic implants, extracorporeal circulation, laser products, ultrasound products, imaging products, medical software, monitoring products, gene sequencing and in vitro diagnostic reagents. We are also keeping good communication with national and provincial food and drug administration, center for medical device evaluation.
|Pre-development phase||Design and development compliance consulting|
|Product usability consulting|
|Product registration and filing||Guidance on writing technical requirements|
|Guidance on writing software and network security documents|
|Product registration and filing|
|Other services||Product classification defining|
|Application medical device innovation application and priority review|
|High risk medical device clinical trial consulting|
|Manufacturer permit consulting|
|Being agent for overseas companies|