ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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Accelerate the Global Impact of Your Medical Devices & IVD Innovations
We help you develop a Global Strategic Product Launch Roadmap using regional, regulatory and commercial insights coupled with proven, experience-driven services for the effective registration and post marketing of your products and services.
Countries Served
70+
Consultants
200+
Device Categories
40+
Submission of Dossier
5
Post Market
7
Approval
6
Process
Classification of Medical Devices & IVD
1
Appoint an Authorized Representative
2
Certification from Conformity Assessment Body (CAB)
4
Preparation of Common Submission Dossier Template (CSDT)
3
KSA
UAE
Middle East
Asia
Newzealand
Armenia
Azerbaijan
Georgia
Kazakhstan
Krygyzstan
Moldova
Mongolia
Tajikistan
Turkmenistan
Ukraine
Uzbekistan
USA
Canada
North America
Europe
Europian Union
UK
Switzerland
Turkey
We break down complex regulatory requirements to help you achieve market adoption in multiple countries, as efficiently as possible. Explore our presence below.
Our Global Network Spanning Over 70 Countries
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