China Widens MAH Scheme To Medtech As Consumables Face Price Cuts
China is quickly expanding its marketing authorization holder scheme from drugs to devices. It is also vowing to reduce medical costs by using more low-cost, domestic consumables, which will have a significant impact on companies.
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The Chinese medtech regulatory system was a key theme at the MedTech Summit in June, where regional specialists gave updates on registration timelines and electronic submissions, and signaled how the world’s biggest market-in-waiting is speeding up its regulatory improvements in a bid to become more open and less forbidding for overseas entrants.
Following in the steps of Merck & Co. and GSK, Pfizer is turning to a Chinese partner to more broadly market one of its top vaccines in the country - but the US firm is going one step further.
Since October, reported cases of infectious respiratory diseases have been rising in China, prompting an information request from the WHO. However, no new types of pathogen or unusual clinical symptoms have been detected so far.