Korea is gearing up to expand its own homegrown domestically produced medical device business. The country is hoping to develop and export more of its own medical devices internationally. In an effort to do this, a few weeks ago, Korea’s MFDS outlined... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. One of the key issues in getting drug approval in Japan is to meet Japanese GMP standards. To register a drug in Japan, foreign drug... Read More
On June 16, the PMDA steering committee announced that in April 2024 or shortly thereafter, the PMDA will open offices in the US and Southeast Asia. Likely locations for these offices are Washington DC and Bangkok, Thailand – although this is not... Read More
China issued draft “Implementing Rules” for HGR in March of 2022. On June 1st, 2023, the draft implementing rules are no longer in draft and will become enforced on July 1st, 2033, according to China’s Ministry of Science and Technology. While there... Read More
Device registration has not been required in Hong Kong. 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 that utilize digital technology like AI, Big Data, and some software applications. The MFDS also said... 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. In China, CDx products are classified and regulated by existing medical... Read More