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Hong Kong, with a population of 7.5 million people, is a good market for medical devices. While voluntary device registration is only required now, mandatory registration is on the horizon. Voluntary device registration is important since Hong Kong hospitals and clinics strongly prefer to buy devices ...

Currently, in the US House and Senate, a potential BIOSECURE Act is on the table. This Act while not finalized or implemented yet, will likely affect US drug and biotech companies and their relationships with China (and to a much lesser extent our dealings with other countries of concern like Cuba, Russia, ...

As noted in our newsletter over the last year, Japan’s MHLW has tried to partially correct the Japan drug lag problem by allowing for higher prices for innovative drugs. Under the 2024 drug pricing reform, the MHLW has continued to support the Price Maintenance Premium (PMP), increasing it in some cases, ...

On March 12, the Indian Department of Pharmaceuticals issued a new regulation for drug marketing called the – Uniform Code for Pharmaceutical Marketing Practices (UCPMP). Accordingly, all pharmaceutical associations in India are required to set up Ethics committees for Pharmaceutical Marketing Practices. ...

On March 6, 2024, Malaysia issued Medical Device Exemption Order 2024, superseding the previous Exemption Order from 2016. This regulatory overhaul introduces an expanded framework for the exemption of certain medical devices from the registration mandate under the Medical Device Act 2012. The most ...