So you got your registration. It was hard, but you got there. All that pesky regulatory stuff is done and now you can get on with the real business of selling product. But, of course, it’s not the end of the story. Regulation is whole-of-product-life and postmarket monitoring matters. No more so than in China, where the latest changes in CFDA regulations mean renewals are now all about looking back at the postmarket record. If you haven’t paid attention to postmarket, expect to struggle with registration renewal. We take a look at the latest changes in China and how to be prepared.
Whether you are subject to the regulatory requirements for Medical Devices and need to comply with the Quality System Regulations and ISO13485, or whether you voluntarily implemented an ISO9001 system to generate efficiencies and improve customer experience, implementing a best-in-class Audit program is key to your Quality operations. Is your Audit program up to the task?
Do you know why some processes are more “Special” than others? Process validation is an essential part of establishing a manufacturing process. Jean Boudaud takes a detailed look at what’s involved and demystifies all that IQ/PQ/OQ stuff.
Taiwan is the most advanced medical device market in Asia with more than 70% market share contributed by foreign manufacturers. Due to its economic performance, rising demand of healthcare products from a rapidly growing aging society as well as National Health Insurance that covers almost all of its 23 million population, the medical device market in Taiwan is projected to grow by over 7% from 2014-2019. This certainly marks Taiwan as one of the most exciting medical device markets for import opportunities.
At the Irish Medtech Global Access conference in Galway this week, a common theme emerged: planned transitional arrangements schedules for ISO 13485:2016, the European Medical Device and IVD regulations and the MDSAP audit program will combine to create a Perfect Storm which will challenge their resources of Regulatory agencies and assessment bodies and manufacturers alike. You may think things are getting busy now, but in reality we are in the calm before the storm. Are you ready?
As regulations tighten – regulators get busier and backlogs and delays are increasing. In this environment, a single audit program not only reduces audit workload – it can offer speedier market access.