The misuse of eyeglasses or lenses can lead to a number of health concerns if they are maintained for a long time. In order to prevent this, Brazil has developed a special eyewear regulation that affects both the prescription and the sale of these products.
Since a federal decree was passed in 1934, only ophthalmologists are allowed to prescribe the use of corrective lenses by examining a patient’s visual acuity. This was reaffirmed by a decision by the Federal Council of Medicine, which stated that knowledge about anatomy, physiology and pathology were required in order to prescribe corrective lenses for eyewear products. The definition of corrective lenses includes both contact lenses and prescription glasses.
Furthermore, a bill was proposed to the Chamber of Deputies in 2011 that would require an Anvisa license for all shops that sold eyewear products, but it was shelved in the following year by its own author.
In 2009, it was up to Anvisa, the National Health Surveillance Agency, to increase regulations over the sale of eyewear, forbidding the sale of corrective lenses in drugstores, except when there is no specific shop for this purpose in the municipality.
Anvisa understands that optometrists' offices are equipped with all the equipment necessary to precisely assess details from the bottom of the patient’s eye, such as lubrication conditions and corneal pressure. These details allow the optometrist to forecast if the patient will have trouble adapting to contact lenses, something that could not be done in drugstores. Also, when analysed by an optometrist, it is possible to diagnose when there are conditions for the development of systemic diseases such as diabetes and hypertension ─ as well as glaucoma, cataract and conjunctivitis.
As contact lenses are viewed by Anvisa as a material of medical use, manufacturers and shops that sell them are required to be registered with Anvisa. Check this article in order to learn how to register with Anvisa.
In order for these products to enter Brazil legally importers of lenses must obtain an Import License from Anvisa before the clearance of the products at Brazilian customs. Information on how to obtain an Import License can be found in this article.
Self-Regulation Mechanism for Eyewear Industry
Inmetro, which is the Brazilian Institute of Metrology, Quality and Technology, and ABNT, the Brazilian Association of Technical Standards also have a say in eyewear regulations in Brazil. In a combined effort with Abióptica, the Brazilian Association of the Optic Industry, a mechanism of self-regulation was created in order to set fixed rules and standards for all eyewear products traded in Brazil, including those that were imported. These entities formed together the Brazilian Committee of Optic and Optic Instruments (ABNT/CB-49).
While requirements for sunglasses were already being set by ABNT since 2004, all other eyewear and related products started being regulated by ABNT in 2011. The following programs will be under regulation of the Brazilian Program of Self-Regulation of Optic Products:
- Corrective lenses
- Lenses blocks
Once the production requirements are met by the companies in this sector, a certificate - in the form of a holographic tag - specific to each manufacturer/brand will allow consumers to identify and trace the products origin.
Adherence to these regulations is voluntary but, as with any kind of certificate, it grants credibility to the final product, making it more desired than a product that is not certified.
Since a Federal Law in favor of more strict regulations over the sale of eyewear was shelved in 2012, some states have designed their own laws that regulate this activity.
A bill approved in 2015 by the state governor of Santa Catarina restricts the sale of glasses without proof of origin and invoice. According to the law, the sale of glasses and the provision of optic services can only be made in shops duly licensed by the state’s organ of health surveillance.
Similar to the law approved in the state of Santa Catarina, at the beginning of 2015 a bill was approved by the state governor of São Paulo that regulates the sale of contact lenses, prescription glasses and sunglasses. According to the law, these products can only be sold in shops specialized in providing this service and duly licensed by the state’s health surveillance organ.
Sunglasses that already meet ABNT requirements can be traded in any shop.
Several other state capitals such as Campo Grande, Curitiba, Manaus, Porto Alegre and Rio de Janeiro passed bills that regulated the sale of eyewear products in the same way as the states of Santa Catarina and São Paulo.