Overview:

The import of Health products into Brazil is subject to various regulations, with proper labelling being a crucial part of this procedure. These regulations cover the current standards for labelling imported products, outlining the responsibilities of importers and the essential elements that must be included on labels.

Introduction:

As established by Collegiate Board Resolution (RDC) 81/2008, it is forbidden to sell imported products that have identification or labelling in a foreign language, except in specific situations described in that resolution. Labelling within national territory of Brazil is authorized for imported products that are duly registered with the National Health Surveillance Agency (Anvisa), in accordance with the applicable legislation.

When displayed or made available for consumption, products must be properly labelled, sealed or have a safety seal, as required by current health legislation. The information on the labels must be approved by the competent health authority during the regularization process with Anvisa.

Labelling in a Foreign Language:

When an imported product enters national territory, the label in a foreign language must include the following information:

– Commercial name used abroad.

– Name of manufacturer and place of manufacture.

– Batch/part number or code.

– Date of manufacture (when required by applicable health legislation).

– Expiry date or expiry date (if applicable).

The health authority may request a translation of the label, duly signed by the technical manager and the person in charge or legal representative of the company responsible for regularizing the product with Anvisa.

Special Cases:

Cosmetics, Perfumes and Personal Hygiene Products: If the information on the date of manufacture and expiry is not present on the label in a foreign language, the importer must provide a declaration signed by the technical manager of the importing company, indicating the date of manufacture for each imported product. The inclusion of the expiry date is not compulsory.

In Vitro Diagnostic Products: In the absence of information on the date of manufacture, the importer must provide a declaration signed by the technical manager of the importing company, specifying the date of manufacture for each imported product, or an analytical quality control report, by batch or batch, signed by the technical manager.

Compliance with these guidelines is essential to ensure that imported products meet Brazilian health standards. Importers should familiarize themselves with the regulations and detailed procedures in order to avoid complications during the import process, thus guaranteeing the safety and quality of the products made available on the Brazilian market.

Conclusion

Importing products into Brazil is subject to a number of regulations, and proper labelling is essential if products are to enter the Brazilian market without any problems. However, it is important to emphasize that the importing company must be a qualified Brazilian company, duly licensed.

If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.

Time GRP Brazil

Brochure : GRP Brazil Services

GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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