Brazil expands production of ventilators
Published: 17 April 2020
The Agency has carried on exceptional actions to expand the production capacity of equipment that are essential to fight the Covid-19 pandemic. Among those actions was enacting the Resolution of the Collegiate Board (RDC) 356/2020, which streamlines procedures for the regulation of medical equipment.
The action is a response to the current context of Covid-19, which puts health systems under pressure and bears relevance to the relationship between demand and supply of medical and hospital equipment. When it comes to the new coronavirus, one of the most important devices is the mechanical ventilator, which helps patients to breathe artificially.
For this reason, Anvisa has worked collaboratively to quickly evaluate projects intended to expand the production capacity of ventilators in Brazil.
Expansion
The work focuses on products already approved by Anvisa, however in facilities not yet licensed. The case of Magnamed is an example. This company is responsible for the project that will expand the capacity of large-scale manufacturing of another company, the Flextronics, which already has authorization from the Agency. Another example is the authorization for the company Weg Drives & Controls - Automação to manufacture and sell mechanical lung ventilation equipment already registered by the company Leistung Equipamentos.
Serious cases
In some cases, especially among the elderly or people with compromised defense systems (immunocompromised people), as the new coronavirus attacks the lungs the disease can lead to breathing problems, pneumonia and multiple organ failure. Considering the global and sudden increase in the need for ventilators, it is necessary to expand those products’ supply.
There is great concern about a possible shortage of ventilators. The impact could cause the death of patients. Therefore, in this context, regulatory exceptionalities are positive.
Project submission
Companies that want to submit projects must be attentive and observe some aspects in such an exceptional evaluation, in addition to the rules already enacted by Anvisa to cope with Covid-19. Therefore, it is important that the company present the data below:
1. Proof of extra demand required to the company;
2. Model and health registration data of the equipment intended to be expanded;
3. Registration data of the company and facilities in which the equipment is currently been manufactured;
4. Registration data of the company that intendeds to expand the equipment production;
5. Description of the compliance certifications obtained by the applicant’s production facilities;
6. Description of the qualification required to assemble the equipment and proof that the company has equivalent qualification;
7. Description of the company’s facilities, proving capacity to assemble electronic equipment;
8. Statement that the applicant will follow the specifications, instructions and procedures described in the original product registration, practiced by the company that has the original registration, including the process tests and final inspection;
9. Statement that the components used by the applicant company will be obtained from the same supply chain currently approved by the registered company, with no inclusion of components from unqualified suppliers;
10. Statement by the company that has the original registration, with electronic certified signature, that its legal and technical officers also assume legal responsibility for all equipment manufactured in the applicant company, including the responsibility for technical assistance and maintenance of the equipment manufactured.
In conclusion, Anvisa reassures its commitment to broaden the access to quality products and that all extraordinary and temporary measures adopted take into account the assessment of risks versus benefits within the Covid-19 pandemic context.