PACKAGE INSERTS AND MANUALS MUST BE PROVIDED IN PORTUGUESE!


When purchasing equipment, many laboratories receive the manufacturer's manual inside the box, written in the language of the country of origin where it was manufactured. Regarding the reagents, some offer package inserts in several languages, being common to find them in English and Spanish.

To comply with requirement 5.4.1 b of RDC (Resolution of the Collegiate Board) 302:2005 of ANVISA, which establishes that the laboratory shall keep written instructions, regarding equipment or instruments, which may be replaced or supplemented by manufacturer's manuals in Portuguese, it is important to know that:

In Brazil, it is MANDATORY to provide the information in Portuguese language.

The Resolution of the Collegiate Board of ANVISA – RDC No. 34 of 06/15/12 that changed the RDC No. 306, of 12/07/04 and establishes the Technical Regulation of Products for Diagnosis in vitro and its Registration, Enrollment, and alterations, revalidations and cancellation, determines:

 

1.12-A – Instructions for use:

They are guidelines provided by the manufacturer or registry holder to the user for the correct, safe and effective use of the product.

 

3.2 Instructions for use

Instructions for use must be available to the user in Portuguese and may be in a non-printed format, since they meet the requirements and conditions established in the specific sanitary legislation.

And the Consumer Protection Code, established by Law 8,078, dated 09/11/90, also determines:

TITLE I – Consumer Rights

CHAPTER V – Business Practices

SECTION II – Offer

 

Article 31. The offer and presentation of products or services must ensure correct, clear, precise, ostensive and in Portuguese language information about its characteristics, qualities, quantity, composition, price, warranty, expiration date and origin, among other data, as well as the risks they represent to the health and safety of consumers.

Aware of this, require from your suppliers to provide these documents in Portuguese!



Published: 3/9/2017

Inscreva-se





Restricted Area