ARTICLE SUMMARY:
The top five Market Pathways articles posted in October to MyStrategist.com include our interview with incoming MedTech Europe CEO Oliver Bisazza, China NMPA's steps to implement medtech reforms, an innovative program in Hainan Province where foreign device manufacturers can collect real-word data on new technologies to win national NMPA approval, improving medtech's quality functions, and FDA's proposed Voluntary Alternative Pathway.
The top five Market Pathways October articles.
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#1: MDR Changes Ahead: An Interview with MedTech Europe’s Oliver Bisazza
The newly named successor CEO of the EU medical device trade association talks about the impending changes that could be adopted to the new Medical Device Regulation to address at least some of the concerns expressed by both industry and regulators, reaffirming that change is the only certainty when it comes to MDR.
#2: China Reforms: Submissions, Clinical, and Postmarket Impacts
State Order 739 was handed down in China last summer, delivering significant reforms in medical device regulation that the National Medical Products Administration (NMPA) is now putting into place at rapid speed. Here’s a look at the underlying principles of the reforms, including clinical evaluation updates, from Grace Palma, CEO of consulting firm China Med Device.
#3: Improving Medtech Quality by Combining PLM and QMS
Confusion abounds at device companies around using product life cycle management for quality functions. The answer may be combining it with an electronic quality management system. By Christine Kattappuram, Veeva MedTech.
#4: Island Evidence: A Quicker Path to China’s Market via Hainan Province?
China’s growing embrace of real-world evidence as a premarket regulatory tool is bolstered by a unique program in tropical Hainan Province, allowing companies to sell their devices and collect this type of data in advance of national approval.
#5: Voluntary Alternative Pathway: FDA Floats Legislation for Agile Regulation
The device center is circulating a proposal for a voluntary program that would give it leeway to pick and choose appropriate regulatory requirements for new technologies.
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