A significant number of manufacturers that look for our regulatory services are not just searching for ANVISA registration services, their doubts are related to INMETRO certification processes and their requirements, which many times are not thoroughly discussed when planning a regulatory strategy for medical devices’ registration in Brazil. INMETRO is the National Institute of Metrology, Quality and Technology. It is responsible for executing the policies determined in the conformity assessment programs and it aims to improve the quality as well as ensure the safety of the products and services offered in Brazil.

Regarding the medical devices market, there are INMETRO ordinances which require certification for several different types of products, although it doesn’t apply to all types of medical devices. The ordinance determines the certification system, procedures and requirements such as:
· factory audit;
· testing (applicable standards);
· documentation needed;
· applicant audit (Brazilian Company);
· certification maintenance.

Products INMETRO Ordinance
Equipment under Sanitary Surveillance 54/2016
Hypodermic and Gingival Needles 501/2011
Sterile Hypodermic Syringes for Single Use 503/2011
Single Transfusion, Gravitational Infusion and 502/2011
Infusion equipment for use with Infusion Pump.
Surgical Gloves and Gloves for Non-Surgical 332/2012
Procedures under Sanitary Surveillance
Male Natural Rubber Latex Condoms 50/2002
Breast Implants 162/2012
The certification is performed by the accredited certification bodies.
The INMETRO certificate, issued by the certification body, is one of the documents that must be delivered over to ANVISA when requesting the registration of the medical devices listed above.
The certification requires time and energy from the regulatory specialists; choosing the right certification body to conduct the process is one of the first but most important steps.
If you decide to enter the Brazilian market and reckon INMETRO is one of the steps needed for the registration, our experts will be pleased to clarify any registration requirements and guide you through the process, avoiding surprises that might affect the product launching schedule.