India has made significant strides in the healthcare sector in the past few decades. In 2017, India's regulatory authority - the Central Drug Standard Control...
Brazil Updates Label Requirements for Wireless Products
The Agencia Nacional de Telecomunicacoes (ANATEL) in Brazil has updated its labeling regulations for wireless products, including some medical devices.
Resolution 662 (link in Portuguese) amends the previous resolution 242 from Nov. 2000. This affects all wireless products that fall under ANATEL’s scope.
The primary changes to labeling requirements are as follows:
1) The Certification number (homologation) and the manufacturer’s identification number have changed. There are now five numbers each. The new labeling format is, for example, HHHHH-AA-FFFFF, where:
- HHHHH: identifies the approval of the product by sequential numbering with five characters;
- AA: Identifies the year of issue of the approval with two numeric characters; and,
- FFFFF: identifies the manufacturer of the product with five numeric character
2) ANATEL has removed the EAN number and bar code requirement for their labels.
ANATEL allows products with limited space for the logo and approval identification code to place these markings on the user manual and optionally on the product packaging. Affected medical device manufacturers should check whether their devices are in fact considered small enough for this exemption.
Related News
In Brief: European Regulators Make Radio and Wireless Revisions, Update Website
Final US FDA Guidance Out on Wireless Technology for Medical Devices
Brazilian INMETRO Risk Management, Auditing Requirements Updated to Reflect IEC 60601 Changes