Overview:
On March 3, 2020, Anvisa published a new regulation “RDC 340/2020” that classifies the changes made to approved medical devices in Brazil, into three categories , based on the level of risk they can present to their users. This regulation will take effect on April 1 ,2020. A summary of such classification is provided here below;
Type of change | Anvisa requirements |
Change considered to be of greater health relevance. | • Modification with required approval • It will be authorized only after ANVISA analyzes the application and issues a favorable opinion.
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Change of medium health relevance. | • Modification for immediate implementation • It will be authorized only after ANVISA analyzes the application and issues a favorable opinion.
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Change of lesser health relevance. It can be implemented at any time by the company without the requirement to submit an application to ANVISA.
| •Non-reportable modification • It can be implemented at any time by the company without the requirement to submit an application to ANVISA.
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Anvisa stated that all medical device changes must be conducted in compliance with Brazilian Good Manufacturing Practice (BGMP).
ANVISA published a news article (link in Portuguese) on their website summarizing the changes and explaining how they differ from current regulations.
GRP Registration Expertise:
Global Regulatory Partners Inc. (GRP), local team of regulatory experts can assist with the registration of your medical device or IVD with the Anvisa in Brazil.