Respirator Mask registration requirements

Amid the rise of flu in recent months and the appearance of Coronavirus (COVID-19), a product that is being widely marketed and sought after is the respirator mask. Developed for professional and personal activities, the mask’s purpose is depriving our organism of harmful particles, such as organic vapors, smoke and harmful gases. It is commonly used by health professionals, but it can be used for other resources and situations in which we need to take better care of our health.

The use of the respirator mask began in the 16th century, according to historical reports, when the renowned Leonardo Da Vinci invented small pieces of thin cloth moistened with water, which at the time had the purpose of protecting sailors from
poisoning. The invention was so profitable for people, that today several models are commercialized all over the world, from the disposable ones to the most modern ones, with their own oxygen.

The importance of registration:

The registration is much more than ensuring the quality of the product to the customer, but it is also the legal act that recognizes the adequacy of an existing product of the Health Surveillance. This concession is provided by Anvisa. It is necessary that this registration is done before commercialization, mainly those products that may present any risks to the consumer’s health. It is a process that requires meeting criteria established by law and aims to minimize any risk that the product may offer.

Health regulation:

Working with products that are directly linked to health, such as the Respirator Mask, needs a lot of care and attention and undergoes a series of certifications, including at your establishment. Therefore, at the first moment you need to make sure that the CNPJ and Social Contract of your company are in accordance with the mandatory information for  marketing the product, so you do not take the risk of having to change your documents to start your projects.

Therefore, it is time to check if your establishment is in accordance with the approvals of your city hall, they are:

• Approved housing and plant;
• Environmental license or waiver;
• Fireman’s certificate;
• Technical report for physical space evaluation (LTA);
• Connection of the technician in charge of his council;
• And Finally, set up the process and apply for the operating license at VISA.

What is VISA?

VISA is responsible for promoting and protecting population’s health, preventing risks and intervening in problems caused by the environment, production, circulation of goods and the provision of services of interest to health. Inspection is not their only function, educating and alerting the population are also part of the Health Surveillance strategy.

What is Anvisa?

The National Health Surveillance Agency (Anvisa) is a regulatory agency, in the form of a special regime autarchy, linked to the Ministry of Health. They are responsible for the sanitary control of all products and services subject to health surveillance, such as medicines, food, cosmetics, sanitizing, medical products, blood products and health services. It is an extremely important organ and is very present in our daily lives, since many products and even hospitals are Anvisa’s responsibilities.

Product regulation:

It’s time to register the Respirator Mask – and since it is part of the correlated medical products (health equipment for laboratory, medical, dental, physiotherapy, aesthetic, therapeutic and used for diagnostics purposes) – it will be necessary to register with Inmetro (National Metrology Institute, Quality and Technology), which will carry out several tests with the product to guarantee safety and efficiency to the costumer.

The test will be carried out in an exclusive way, that is, each product will undergo a different analysis, according to its need, in addition, it will have a degree of risk stipulated by Anvisa.

What are the degrees of risk?

There is a lot of different equipment, subsequential the degrees of risk are important and are foreseen by the RDC nº 185/01 of the National Health Surveillance Agency. This classification is important because each product has a degree of danger to our body or organism, especially those for medical use.

What are the essential security requirements?

The Resolution of the Collegiate Board (RDC) on security requirements is RDC No. 56/2001. With it you will have a list of basic requirements for the assessment. This list is very important for the regulation of medical equipment at Anvisa. Check out the items on this list:

• Chemical, physical and biological properties;
• Protection against mechanical risks;
• Radiation protection;
• Manufacturing and environmental properties Products with measurement and diagnostic function;
• Performance evaluation presenting, when necessary, evaluation and clinical investigation of the medical product;
• Requirements for medical equipment connected to, or equipped with, an electrical power supply;
• Infection and microbial contamination;
• Protection against the risks associated with the administration of energy and substances to the patient;
• Protection against risks associated with equipment for self-testing and self-administration;
• Information provided by the manufacturer (precautions, warnings, indication of use, instructions for use, etc.).

Where can I find my registration?

As soon as the regulation is approved by Anvisa, the registration number will be published in the Federal Official Gazette (DOU). With the publication already sufficient for proof of legality. Thus, you can now produce and market medical equipment.

When to renew a registration?

The regulation is valid for 10 years. Anvisa requires that the renewal be made in the first half of the last year of validity.

Licempre does everything for you!

We are a company specialized in registries, with a team of professionals trained and prepared to deal with all types of requests, in all regulatory bodies.

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