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- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
- The Vietnamese MOH Issues Draft Decree to Address Delays December 14, 2022
- Thailand FDA Publishes Guidance for Software as Medical Device December 14, 2022
- China NMPA Updates Compulsory Standards for Medical Devices December 6, 2022
- 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
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India Issues Final Notice Exempting Certain Class A Medical Devices
/in India, Latest Updates/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 Updates/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 Updates, 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 Updates/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 Updates/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 Updates, 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 Updates/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.
Expedited Market Access Now Available in Philippines
/in Latest Updates, Philippines/by Charmaine RosonOn September 27th 2022, the Philippines FDA published Circular No. 2022-008 announcing that Class B, C, and D medical devices that have been already approved by a member country of the Association of Southeast Asian Nations (ASEAN) will be eligible for the Reliance registration route, allowing for a quicker review and expedited market access.