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- China NMPA Updates Classification of Sodium Hyaluronate Products November 18, 2022
- India Issues Final Notice Exempting Certain Class A Medical Devices November 14, 2022
- China’s NMPA Publishes Classification Catalogue Adjustments for Comment November 8, 2022
- Thai FDA Fast Track Route for COVID Related Products to Stop November 4, 2022
- China’s NMPA Begins Issuing Registration Certificates Electronically November 1, 2022
- Good Distribution Practice Requirements in Indonesia October 28, 2022
- Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea October 25, 2022
- India Issues New Sales License Requirement for Medical Devices October 10, 2022
- Expedited Market Access Now Available in Philippines October 4, 2022
- India Grants Import License Grace Period for Class A/B Devices September 30, 2022
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China NMPA Updates Classification of Sodium Hyaluronate Products
/in China, Latest News/by Bryan GilburgOn November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
India Issues Final Notice Exempting Certain Class A Medical Devices
/in India, Latest News/by Gunjan VermaOn October 14, 2022, the Indian Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued final notification G.S.R. 777(E) formalizing the exemption of Class A non-measuring and non-sterile medical devices from the Import License (MD-15) process.
China’s NMPA Publishes Classification Catalogue Adjustments for Comment
/in China, Latest News/by Bryan GilburgOn October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.
Thai FDA Fast Track Route for COVID Related Products to Stop
/in Latest News, Thailand/by Noi SuwannabotThe TFDA has announced that the Fast Track registration route for COVID related products will be discontinued from November 4th, 2022 onwards.
China’s NMPA Begins Issuing Registration Certificates Electronically
/in China, Latest News/by Bryan GilburgOn October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
Good Distribution Practice Requirements in Indonesia
/in Indonesia, Latest News/by Ilham HidayattulahIn 2014, the Indonesian Ministry of Health introduced the Good Method of Distribution of Medical Devices (or CDAKB) in order to enforce good distribution practice requirements in the country.
Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea
/in China, India, Japan, Latest News, South Korea, Taiwan, United States/by Albert PranotoAn outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.
India Issues New Sales License Requirement for Medical Devices
/in India, Latest News/by Gunjan VermaOn September 30th, 2022, the Indian Ministry of Health and Family Welfare (MOHFW) issued GSR 754(E) announcing new sales license requirements for entities importing and distributing formerly non-notified medical devices.