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Brazil proposed requirements of the Notification regime for sanitary control of low-risk medical devices

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Brazil proposed requirements of the Notification regime for sanitary control of low-risk medical devices

Brazilian Health Regulatory Agency (Anvisa) proposed Resolution has the objective of defining the requirements of the Notification regime for sanitary control of low-risk medical devices exempted from registration pursuant to § 1 of article 25 of Law 6,360, 23 September 1976.

This Resolution applies to low-risk medical devices classified in risk class I, according to the classification rules available in RDC 185, 22 October 2001, and RDC 36, 26 August 2015.

Product covered: Medical Devices

HS code: 90

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: NA

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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