Mohammed,
If assistance is required in determining whether a product is a medicine or a medical device the sponsor of the product should collate the information required on the Medsafe website and submit this to Medsafe at askmedsafe@health.govt.nz and request for the categorization status of the product.
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Bob Wilkinson
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Original Message:
Sent: 09-Nov-2022 13:28
From: Mohammed Ahsan Siddiqui
Subject: Pen combination products: Requirement for separate registration of device?
Hi RAPs community,
What are Medsafe's guidance and regulatory requirements for Pen Combination Products in New Zealand? Will this be considered and registered as New Medicine? or device need to be separately registered?
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Mohammed Ahsan Siddiqui
Lucknow
India
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