Medical device registration in Hong Kong has been voluntary. Over the last 10 years or so, medical devices could be registered on Hong Kong’s voluntary registration list. However, only about 20% of the medical devices sold in Hong Kong are on the... Read More
Recently, India Central Drugs Standard Control Organization (CDSCO) announced that all Class C and Class D non-notified medical devices will need a comprehensive license by October 1st, 2023. In 2020, the Indian Ministry of Health and Family Welfare outlined its definition of... Read More
Everyone knows that the China drug market is very large. However, national and provincial tenders, Volume Based Procurement (VBP), the DRG system and other recent measures have significantly lowered pricing and reimbursements. To get drug reimbursement in China, a company needs to... Read More
While Japan is a huge drug market with decent reimbursements, in many ways it is not progressing as quickly as many developed foreign drug markets. In an effort to jump-start more drug activity in Japan, in early July, the Japanese MHLW will... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) has announced that all RWE can be used as clinical data to expedite the registration of medical devices in Korea that utilize digital technology like AI, Big Data, and some software applications. The MFDS... Read More
While the West and Japan are prioritizing personalized medicine and the use of Companion Diagnostics (CDx) to determine which patients will benefit from specific drugs, development in China has been slow. CDx products in China are classified and regulated by existing medical... Read More
Drug prices in Korea, like other markets around the world, have seen drug price erosion. Korea’s MOHW, earlier this year, established a private-public working group to discuss increasing reimbursement for innovative drugs. The goal of the Korean group is to foster new... Read More
The China cancer drug market is experiencing exponential growth. According to a recent Research and Markets report there are about 5 million cancer patients in China now and by 2027 the market size will be over $35 billion. Cancer is rampant in... Read More
Normally, every two years in April the Japanese government revises drug prices. Recently, such revisions have occurred annually or in so-called “off years”. Drug price revisions went into effect on April 1st, 2023. Drugs in Japan with price variances between their market... Read More
On April 4, China’s NMPA promulgated 2023 new medical device registration guidelines. These guidelines affect China medical device registration, type testing, clinical trials, etc. The guidelines for Class 3 medical devices include 36 new guidelines and 27 revisions. Examples of Class 3... Read More