Case Study 121: Regulatory Strategy for Class IV Regenerative Medical Device in Brazil

Client Situation

An Australian company specialized in the development and commercialization of regenerative medicinal products wanted to commercialize its products in Brazil and needed support from a regulatory expert in Brazilian regulations to establish the RA strategy for the product’s registration in Brazil. The product is a collagen based medical device that facilitates tissue repair and healing in a variety of orthopedic. The devoce is considered very high risk in Brazil and classified as Class IV in Brazil.

GRP Can support your Regulatory, Clinical, Quality & Safety Needs

Stay updated on the Latest Regulatory Information