Market Authorizations (MAs) for drugs in Thailand before 2019 never expired. With the implementation of the 2019 Thai Drug Act, drug MAs were only good for 7 years but could be renewed. Now, the Thai Drug Act has set out a detailed... Read More
On April 11, the NMPA issued a new Circular on year-end drug annual reporting. China MAH’s must submit 2021 annual reports by August 2022. However, after this year, annual reports must be submitted by the end of April each year. The circular... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Being a local agent for medical device products in China is going to get significantly more rigorous. Some of the new requirements now in draft form, will be implemented soon. According to the new regulations, the NMPA organized the drafting of “Measures... Read More
If a foreign medical device company does not have its own office in China and does not want to let their distributor register their product there, registration can be done by an independent third-party company (agent) located in China. In all three cases,... Read More
INTRODUCTION With incomes rising among its rapidly aging population of 96.7 million, Vietnam is a booming market for pharmaceuticals. Long one of the least-developed pharmaceutical markets in Asia, with relatively low per capita spending on drugs, Vietnam has tremendous potential. According to... Read More
A Malaysian law requiring companies that manufacture or market medical devices in the country to register with the government goes into full effect this month, six years after it was first passed. The 2012 law was designed to bring Malaysia, which imports... Read More
Unlike the other Asian countries, in Indonesia, an independent, third party entity in-country cannot register foreign devices. According to Indonesian law, devices can be registered via the foreign company’s Indonesian distributor or the foreign company’s subsidiary operation in Indonesia. To get around... Read More
Cancer is growing very quickly in China. At the same time, Chinese citizens are becoming wealthier and demanding higher quality medical products and services. Thus, Western medical device companies marketing their cancer products in China are seeing rapidly increasing demand. Western medical... Read More
For more information about Chinese in-country representatives, please see Local Agent Representation for Medical Products in China. You are welcome to use or share this infographic online or in your presentations and papers, as long as you include credits to Pacific Bridge... Read More