This new regulation revokes the old RDC 59/2008 and Normative Instruction 1/2009 and brings important changes related to the criteria for submitting orthopedic implants, facilitating the grouping and allowing the registration of new products in Brazil.

Criteria for Grouping Implantable Materials

Art. 15. For the grouping of implantable materials in orthopedics into a system or family, the following criteria must be considered:

1. Nature of the material
2. Constitution
3. Form of fixation
4. Functionality
5. Intra component degree of freedom
6. Scope of implementation
7. Level of interference in the epiphysis
8. Association or not with a pharmacological agent.

Implantable materials in orthopedics that have different types of material covering of different natures must be regularized in different family or system records.