While many overseas medical device makers are hoping that approval in the “Country of Origin” will no longer be required for medical device registration in China, this regulation has not yet been changed in China. Under the current framework (Order 739), an imported device must still be approved in its country of origin before NMPA registration, unless it qualifies as an innovative device. This potential change is addressed in the draft Medical Device Administration Law (MDAL). Article 47 of the draft MDAL would eliminate the COO approval requirement entirely, meaning NMPA review in China could proceed at the same time as, rather than only after, regulatory review in the device’s home country. However, the MDAL remains a draft — it was released for comment in August 2024, reissued in March 2025, and implementation was not expected before 2026. As of now, it has not been passed by the National People’s Congress (NPC).
In Japan’s medical device market, success often relies heavily on strong support from Key Opinion Leaders (KOLs) and academic societies. While it is always best to meet in person with KOLs and academic societies when possible, KOLs and academic societies often do not have the time to meet in person. Thus, engagement increasingly favors online web meetings, driven by doctors’ packed clinical schedules and strict hospital rules barring non-hospital business during work hours. Post-COVID, web conferencing has become widely accepted. A hybrid model is emerging as best practice: a sales or other Japanese representative visits in person while other team members join remotely. This cuts travel budgets without sacrificing relationship-building. All engagements still follow standard advisory practices: manufacturers sign a formal advisory contract and pay doctors the industry-standard honorarium for their time.