How to register agricultural “EPI”?

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How to register agricultural “EPI”?

Also known as Individual Protective Equipment, “EPI” is a set of items that help in the protection of rural workers. All agricultural production areas use this equipment to protect employees.

The use of rural PPE is very important to preserve the health of those who work with agribusiness, because the correct use of equipment avoids contact with toxic elements and reduces the chances of accidents, such as cuts or perforations.

Individual Protective Equipment is so important that they have become mandatory. It is generally recommended for those who work in the planting, harvesting, spraying and also in the storage and transport of phytosanitary.

The rural EPI kit can consist of: shirt, pants, boots, gloves, cap, visor, apron and mask.

The Certificate of Approval (CA) of “EPI”, is regulated NR-6 of Personal Protective Equipment and can be found on the government website.

To register Individual Protection Equipment with ANVISA, it is essential to have the knowledge of its classification. Stone Okamont can help you get your product registration.

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Who can ask ca to market Personal Protective Equipment?

All manufacturers or importers of the product may request the Certificate of Approval before marketing it as Personal Protective Equipment (PPE).

Operating License to register PPE

The Operating License to  register  Individual Protective Equipment is made together with VISA where the company is established. In this process it is up to the institution to adapt its physical structure in order to receive an inspection from a visa supervisory agent. The adequacy of the site must be in accordance with the RDC (Collegiate Board Resolution) related to the types of products that the company intends to market.

Company Operating Authorization to Register PPE

The Company Operating Authorization is a document issued by ANVISA to prove that the company is authorized and qualified to perform its functions.  This process has a federal scope and will be evaluated directly by agents of ANVISA (National Health Surveillance Agency).

At this point, documents compilation, collection of fees, and other processes to obtain individual protection equipment registration occurs.

How to register agricultural PPE in ANVISA?

The Product Registration is a document issued by ANVISA, legalizing it for commercialization. To register Individual Protective Equipment, the manufacturer and/or importer of “EPI” are responsible for proving the effectiveness of the protection of the equipment, before the distribution of the “EPI”. 

Do I need the Certificate of Good Manufacturing Practices to register agricultural PPE?

Depending on the type of risk rating your product fits. In the case of products in Risk Class III or IV, the company must obtain a Certificate of Good Manufacturing Practices to ensure quality in production.

We can help you!

The regularization processes to register Individual Protective Equipment is very complicated and bureaucratic, without necessary knowledge in the area it is practically impossible to complete them without having to redo it several times, thus dispersing a lot of time and money.

To do this, Stone Okamont has regulatory experts to advise you at every step and ensure that the course of each process is as quickly as possible at the lowest cost.

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Nayara Barillari
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