How to conduct product registration at ANVISA ?
Anvisa is one of the most tough regulatory agency in the world and often international manufacturers get tired and frustrated when go into this process by their distributors or even through local outsourced regulatory agents.
Indeed, the process itself is complicate, timing consuming and very challenging, beyond to demand, many times, some previous certificates. Due that, in order to meet manufacturer expectations and strategic goals, is highly necessary to build up a detailed plan preventing lead-times & mile-stones, budget and actions in order to be preperad to problems and have a hands on solution for each step.
Some new very recent Anvisa's resolutions (RDC 751/2022 ; RDC 665/2022) have modified rules, steps and processes - in any manner facilitating the whole process. Therefore, LABD Regulatory Affair team daily keep up with ANVISA and take mesures to ensure to meet previously settled goals.
INMETRO
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Electric devices must get previously INMETRO cert. with special IEC reports demanded
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Measuring products, PPE, needles and catheter, among others, also requires INMETRO
ANATEL
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Devices using wireless and/or Bluetooth connection required previous ANATEL cert.
STRATEGIC REGULATORY AFFAIR PLAN
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Fit the product in with Anvisa's classification rules
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Set up the timeline & actions
MECHANICAL TEST REPORTS
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Implants devices must fulfill ANVISA test reports
ANVISA GMP
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Product class risk III and IV request the ANVISA' inspection and GMP certificate