Japan Advances Regulatory and Reimbursement Frameworks for SaMD Products After a slow start, Japan is now taking decisive action to modernize its regulatory and reimbursement systems for Software as a Medical Device (SaMD), aiming to match the rapid pace of global healthcare... Read More
The Hong Kong government has been updating its regulatory framework for medical devices, with a number of key changes that seek to enhance safety, efficacy, and compliance. Compulsory Procurement Registration On June 21, 2023, the Hong Kong Department of Health (DOH) launched... Read More
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... Read More
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... Read More
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... Read More
The Thai Food and Drug Administration (FDA) has recently updated its regulatory framework, introducing changes designed to streamline the process for device registration in Thailand. These changes, which take effect immediately following their publication in the Royal Gazette, are aimed at simplifying... Read More
Over the last 5 years, relations between the US and China have been deteriorating, while EU-China relations have held relatively steady. However, recently China-EU relationships have begun to deteriorate too. One example of this is an EU investigation to be started soon... Read More
In an effort to improve the quality of medical devices on the Chinese market, the NMPA, led by the National Institutes for Food and Drug Control (NIFDC), will do sampling inspections at various healthcare facilities. Sixty-six product types will be sampled including products... Read More
Vietnam is facing significant health challenges, including high rates of heart disease and cancer, as the country is experiencing a rapidly growing middle class and strong economic development. With over 97 million people, Vietnam’s demand for better healthcare services, including access to... Read More
The Chinese NMPA is very interested in increasing the number of drugs approved in China each year to better serve its citizens. Over the last 8 years, since China joined the ICH and implemented a number of streamlined drug registration regulations, annual drug registrations... Read More