In order for an OEM to market its products in China, the product needs to be manufactured locally i.e. within China. This is where the role of the contract manufacturer is of prime importance.
Alex Wallstein comes with many years of senior management experience in the medical device industry, including positions at Johnson & Johnson and Medtronic in Minneapolis and Shanghai.
The year 2021 has brought with it a host of changes in addition to dealing with the ongoing pandemic, such as the EU MDR update that went into effect in January 2021. The update of the FDA QSR to match more completely with the ISO 13485; and the FDA 21 CFR Part 820.
Embolization coiling is a minimally invasive catheter-based procedure that employs a coil that can cause an occlusion. What’s important is that the design is made easy to handle and produces the desired effect at the intended location.
The new MAH or Marketing Authorization Holder Policy has opened up a whole new level of opportunities for medical device companies. OEMs must capitalize on the major changes taking place in the Chinese market in allowing high-quality medical devices to be manufactured and marketed without as many restrictions as they experienced prior to the MAH Policy.
If these core elements are not carefully assessed, planned and tested through prototyping, the problems arising at the FDA approval stage, production stage and usage with the end-users will negate profitability