New ANVISA resolution changes to Cadastro classes I and II:
RESOLUTION – RDC No. 40 OF 26TH AUGUST 2015
states the changes to PRODUCT REGISTRATION FOR CLASS I and II Medical Device product.
The most important points of the DRC No. 40/2015 are as follows:
* Requirement of Technical Dossier for all products registered with ANVISA.
The Brazilian company owner of the registry must keep at its headquarter a complete Technical Dossier in case of inspection by ANVISA. The Technical Dossier for each product registered in ANVISA must be completed by 08.26.2016.
* The products subject to Cadastro registration are exempted from revalidation as long as they follow the following rules:
Maintaining the registry must observe the requirements of Good Manufacturing Practices, the applicable technical standards and specific regulations, if existing.
The products subject to conformity certification under SBAC may only be imported and marketed with a valid Certificate, respecting the date of manufacture of the product.
* Imported medical products must submit:
For new Cadastro registrations with ANVISA, the company must submit beyond existing required documentation: a consularized declaration statement, accompanied by an official translation issued by the responsible manufacturer (s), for a maximum of two years, when there is no express validity indicated in the document, authorizing the importer to represent and market the product (s) in Brazil.
* The Resolution enters into force sixty (60) days after the date of its publication
In Portuguese: atchemed.com.br