You Ask, We Answer. It is as simple as that.
Once you become part of our global Xchange community, our team will take up your question regarding any country/product/therapy area/regulatory function of your interest and provide detailed feedback. You can also access to the answers provided by our team to questions asked by other community members.
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Yes, Kenya Medical Devices Authority (KeMDA) does accept US FDA approval as a reference for medical device and diagnostics registration. However, similar to CE marking, US FDA approval alone is not sufficient for registration in Kenya. Manufacturers must still comply with additional requirements set by KeMDA, which may include providing additional documentation or undergoing specific testing or evaluation processes.
We provide detailed information about country specific regulations and answers to frequently asked
questions. You will be able access insights to global regulations around product registration, GMP,
import, labelling, post approval requirements, renewals, variations, Pharmacovigilance, market
access, pricing and reimbursement, medical affairs and other topics.
Special Access provide deeper insights into the country regulations primarily driven by practical
questions asked by the community and expert answers provided by Artixio’s team. The dialogues in
Special Access also includes real case studies, challenges faced by the community or Artixio team
and solutions thereof. The insights from the dialogues in Special Access are actionable and of
pertinent value for MedTech Innovators from the community in advancing their global product
development, product launch and post market maintenance.
Artixio’s Global Regulatory Affairs eperts based in the country of your interest will answer the questions. All our
team members have 15+ years of experience working with Local Health Authority right from regulatory strategy, product development, registration and post market maintenance for biologics, biosimilars, pharmaceuticals, medical devices and diagnostic products.
The response time depends on following parameters:
As we take up questions from the community, there is a schedule based on the number ofquestions and the queue. Depending on the number of questions from the community, theturn for your questions may take few days to weeks.
Complexity of the question: Some question might require our regional and global teams to deliberate to
provide detailed and accurate answer. This may affect the time of response.
While we try our best to provide answers to all the questions at the earliest, in case you are seekinganswers on priority to due to business need, you can use our Xpress service by writing to info@artixio.com. We charge additional fee for Xpress service based on the complexity and scope of answers expected.
Artixio Xchange
Xchange is the one stop for all your queries related to Regulatory Affairs, Pharmacovigilance and Market Access in countries around the world. Xchange is powered by Artixio’s Regulatory Experts based over 100 countries around the world with over 15 years of experience in successfully managing regulatory affairs for Medical Devices, Diagnostic products.
