All documents were published by the Medical Device Control Office (MDCO) in Hong Kong and are in PDF format.
Brazilian Medical Device Regulators Take First Steps toward Electronic Registration System
ANVISA, Brazil’s medical device market regulator, has announced plans to implement a system for electronic submission of registration applications based on guidelines from the International Medical Device Regulators Forum (IMDRF).
The IMDRF system, known as Regulated Product Submission (RPS), is being developed to facilitate greater uniformity of premarket device submissions and approvals across different national markets. ANVISA and other participating regulators will begin their RPS implementation effort by defining and adopting a “Table of Contents” within the next few years.
Emergo will provide further details of the RPS project in Brazil and other markets over the coming months.
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