We are monitoring closely the current initiative taken by CFDA to reform its registration and regulatory policies and believe this reform should positively impact medical device entry to China by US and international medtech companies:
On May 11, the CFDA released three documents for public comment aiming to reform clinical trial management; accelerate review and approval process; and implement full life-cycle management; for encouraging pharmaceutical and medical device Innovation. These three documents mark a big step forward for the CFDA in reforming the registration system for pharmaceutical and medical devices and reflect some of the major issues that the industry has been advocating on for decades. On May 12, the CFDA further released Policies on Protecting Innovator’s Interests for Encouraging Pharmaceutical and Medical Device Innovation, to establish a pharmaceutical patent linkage system and improve test data protection system. The systems and measures proposed in this draft provide more detailed regulations for enforcing existing measures, showing the CFDA’s determination in further strengthening IPR protection and creating an atmosphere that rewards innovation…
These four new policy documents immediately raised awareness among active players in China’s healthcare industry. Dr. Yang Dajun, President and CEO at Ascentagen Pharma called it “a groundbreaking reform, full of courage”. “The policies would create a well-rounded platform for innovation, increasing global development efficiency and accelerating patients’ access to new therapies”, commented President and CEO of Fountain Medical Dan Zhang. SAPA-China President, Johnson&Johnson Scientific Director Dai Weiguo also pointed out “this is a revolutionary progress, with high potential for pharma and medtech companies.”
The shortage of clinical trial resources and the CFDA’s rigorous requirement for clinical trial data have always been major issues slowing down market access of innovative drugs and devices. The CFDA’s new regulations on encouraging the establishment of private clinical research institutions, accepting foreign clinical trial data, and supporting extension clinical trials all address the existing major disadvantages of China’s current clinical trial system and show the Chinese government’s determination in developing early-stage R&D capacity. These regulations also increase the overall efficiency of the registration system, allowing companies to bring their products into the Chinese market in less time and at a lower cost. In addition to simplifying the review procedure, the CFDA will adopt stricter standards to improve the safety and quality of drug and medical devices and further standardize the Chinese healthcare industry. Implementing full life-cycle management may lead to higher compliance standards. Thus, companies may hope to reexamine their current product strategies and consider expanding their product variety, as well as examine their current operations in China and ensure that they are in full compliance with the CFDA’s standards.
Contact China Med Device (CMD) team if you would like to know more about CFDA’s registration and policy reform and get immediate help in accelerating your device’s market entry in China. Please call us 978-390-4453 or email info@ChinaMedDevice.com. Click here to find out more about CMD’s turn-key China regulatory service for your medical device.
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CMD helps medtech companies tap into the fast-growing medical device market in China. Along with our regulatory service, CMD helps its clients accelerate China entry and growth by offering: market intelligence and research, clinical study and trial design management, distribution qualification and management, and partnership and strategic funding guidance. Visit our website https://chinameddevice.com for more information.