Medical device manufacturers often underestimate the time and money needed to establish and nurture distributor relationships. Whereas mda is the manufacturer and distributor of certain.
A the seller manufactures certain medical device products the products as defined in appendix 1.
Medical device distribution agreement template. This distribution agreement the agreement is made on the day ordinal number day of month year by and between supplier name with a principal business address at underlined space for supplier business address including state and zip code the supplier and distributor name with a principal place of business at underlined space for distributor business. The distribution of pharmaceuticals and medical devices the distribution as well as the underlying agreements between suppliers and distributors the distribution agreements are subject to a strict regulatory regime. Distribution agreement biotronik ag and conor medsystems ireland ltd.
The tool is provided to advamed and eucomed member companies solely for informational purposes and should not be construed as providing recommendations endorsements or legal advice to any company distributor or other party. Hpra guide to distribution of medical devices including in vitro diagnostic medical devices draft ia g0004 02 328 1 scope the purpose of this document is to provide guidance to industry in the area of distribution of medical devices in vitro medical devices and their accessories for human use in ireland. And sometimes they overlook the importance of a strong distributor agreement which is the foundation of a lasting distributor relationship.
So you found a great distributornow what. Whereas zeltiq has developed and manufactures markets and sells medical devices and related items. Whereas distributor is experienced in the importation distribution marketing sale and support of such equipment and desires to promote and distribute certain zeltiq products in the territory as defined below.
Manufacturerssuppliers have to observe compre. Should biotronik by any applicable law or regulation be obliged to report medical device incidents this agreement shall not prevent biotronik to do so. This distribution agreement this agreement is made and entered into as of november 15 2003 the effective date between arthrocare corporation a delaware corporation arthrocare and medical device alliance inc a nevada corporation mda.
This agreement is made and entered into on day of month year by and between seller the seller a company located at seller address and distributor the distributor a company located at distributors address. For the purpose of this document all such medical devices shall be referred to. The european unions eu medical device regulation mdr officially passed in april of 2017 may cause significant changes to the regulatory obligations of legal manufacturers importers and distributors involved in the medical device distribution chain.
The tool is intended as a general guide and is not tailored to specific risks. Free customizable distribution forms.
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