In 2021, China’s Patent Linkage regulation went into effect, and both the Chinese National IP Administration (CNIPA) and Beijing IP Court have the responsibility for determining patent linkage. To date, the Beijing IP court has reviewed over 12 patent linkage cases, and... Read More
Several months ago, Vietnam’s MOH released Circular 10/2023/TT-BY updating pre-market requirements. There is now a new document list for device dossiers. While Class D and Class D devices still need CER reports for submission, Class B devices no longer have this requirement.... Read More
Recently, China’s NMPA has started to implement more programs for drug safety. Drug supervision has increased, and the number of crackdowns has jumped dramatically. Last year, there were about 160,000 regulatory investigations of false drug claims, inoperative medical devices, and other problematic... Read More
In the past, API regulations in Singapore have been governed by the Poisons Act 1938 and the Medicines Act 1975. Under the Medicines Act, wholesalers and importers of APIs are recommended to apply for GMP certification, and under the Poisons Act, they... Read More
The Indian government issued the National Medical Device Policy 2023 to help develop more locally-made medical devices in India. Currently, India imports about 82% of their medical devices and the Government is looking to change this. While this 2023 Policy was a... Read More
On July 24, China’s NMPA issued a new list of medical devices not subject to clinical evaluation. This announcement is effective now. Now, device companies want to review the Clinical Evaluation Exempt Catalogue before checking the Clinical Trial Exempt Catalogue. For medical... Read More
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, 2023, according to China’s Ministry of Science and Technology. While there... Read More