How is the registration of respirators done at Anvisa?

Respirators are health equipment that aims to assist in the treatment of patients with respiratory issues.

With the arrival of the Covid-19 worldwide Pandemic, respirators have become essential equipment in cases where patients have more severe symptoms and breathing problems, and so that, these devices are needed to avoid any risk of complications or possible termination.

During the pandemic, the demand for new respirators was nationwide and worldwide for the treatment and there was a need to increase the manufacture and commercialization of this equipment in question.

What are pulmonary respirators?

The pulmonary respirator or also known as a pulmonary ventilator or mechanical ventilator is used in patients with respiratory problems. In case of Covid – 19 patients, they are used to treat more severe patients. The most advanced models are widely used in the Intensive Care Centers (ICUs). 

In case of Covid-19 patients considered to be severe, shortness of breath is one of the most worrying symptoms that causes the critical condition, which can quickly evolve to lung  infections that lead to pneumonia and the inability to breathe. 

Pulmonary respirators are connected to the airways via tubes or special masks and assist in optimal ventilation of the lungs. 

For this reason, pulmonary respirators, especially during the new coronavirus pandemic, are essential for the treatment of patients. 

There are several models available on the market with varying levels of complexity and all need to be registered before they can be commercialized and used. 

How is the registration of pulmonary respirators done at Anvisa?

The registration of pulmonary respirators at Anvisa is mandatory and the manufacturer needs to follow a step by step, with the gathering of information, carrying out tests and compliance with standards followed by the regulatory agencies’ bodies.

See the step by step that manufacturers must follow to register pulmonary respirators.

Step 1 – Feasibility and Regularization of the company. 

In this first phase, the manufacturer must follow the rules RDC 16/2014 (AFE requirements), RDC 39/2013 (Administrative Certification Process) and RDC 16/2013 (Good Practice Requirements for Health Products and must request:  

• Sanitary License (Visa Local);
• AFE, CBPF and CI;
• Certification of Good Manufacturing Practices issued by ANVISA for High Risk Equipment (Class III);
• Certification by SBAC (INMETRO).

 Step 2 – Project control and development 

In this phase, the manufacturer needs to validate the processes, produce the pilots or initial units and request verification of compliance with the product master record and consistency of production, in addition to the Operational Technical condition (CTO), following the standard RDC 16/2013. 

Step 3 – Certification of Conformity (Inmetro) and Product Registration (Anvisa)

In the final phase, the validation of processes and utilities, the production of pilots or “serial heads” is carried out and needs the Technical Operational Condition (CTO) following the rules of RDC 185/2001, RDC 56/2001, RDC 16/2013. 

After all steps are taken before the regulatory bodies, and the product is approved by Anvisa, the manufacturer can sell it.

Registration of respirators during the new coronavirus pandemic

Anvisa – National Health Surveillance Agency has been adopting measures to make the registration of new respirators more flexible during the pandemic to expand the manufacturers’ production capacity in order to face the Covid-19 pandemic.

According to the Resolution of the Collegiate Board (RDC) 356/2020, the measures simplify and streamline the processes for regularizing medical equipment.

The activities are focused on projects that aim to expand the manufacture of products already approved by Anvisa.

The concern of this measure is to assist in the supply of equipment in hospitals throughout Brazil, since patients in Covid-19 who have severe respiratory symptoms need this equipment, so, due to this scenario, it is important to have these measures.

How are the projects presented?

Companies interested in presenting projects for the registration of respirators must follow the rules contained in the resolutions – RDCs for coping with Covid-19. In addition, it needs to present the following documents, see below:

1. proof of extra demand required from thecompany;

2. model and health record of the equipment for which it is intended to expand the productivecapacity;

3. company and site registration data currently registered for theequipment;

4. registration data of the company in which it is intended to expandproduction;
5. description of the certifications obtained by the establishment in which it is intended to expandproduction;

6. description of the training required to assemble the equipment and proof that the establishment candidate for expansion has equivalence or that there will be training in the minimum curriculummatrix;

7. description of the facilities of the establishment that is candidate for expansion, demonstrating the capacity to adapt the area to the assembly of electronicequipment;

8. statement that the applicant company will follow the product registration, practiced by the establishment that holds the registration, including the process and final inspectiontests;

9. Declaration that the components used in the assembly by the applicant company will be obtained from the same chain of suppliers currently approved by the registered company, with no inclusion of components from unqualifiedsuppliers;

10. Declaration by the company holding the registration, with electronically certified signatures, that the legal and technical responsible persons of the company also assume legal responsibility for all equipment manufactured in the company that is applying for expansion, including responsibility for technical assistance and maintenance of the equipment manufactured. in this extraordinary condition.

Licempre, is a company specialized in regulatory matters and provides all the assistance so that your registration process is done safely, quickly, and effectively.

Now that you know how to register respirators at Anvisa, you can count on our experts to answer your questions or learn more about registering companies and products. Contact us and count on Licempre.