Companion diagnostics (CDx) play a pivotal role in personalized medicine—one of the fastest growing areas of medicine. Regulation of CDx is fairly well established in western countries, but the east is not far behind. Here we look at current and on the horizon regulatory guidances and directives for CDx manufacturers seeking to enter the Asian markets.
The short answer is yes, but doing your homework in advance is now more important than ever.
Increasing demand for custom surgical implants and growing investment in R&D will help the sector experience significant growth over the next five years.
China’s medical device market has grown significantly over the last five years, but with that growth comes some pitfalls.
Although opportunities in Japan are still considerable, foreign device companies need to do their homework to be successful.
Despite the high stakes of data vulnerabilities to the entire healthcare system, governments in Asia lag behind in mandating cybersecurity measures, leaving manufacturers to install and maintain systems to protect against cyber criminals.
Fueled by an urgent need for diagnostic testing to respond to COVID-19, the in-vitro diagnostics market is experiencing explosive growth across Asia and around the globe.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.
These countries have been more successful with managing the virus than the United States and the European Union.