Search Our News
Latest Headlines
- India’s CDSCO Extends List of Notified Devices January 13, 2021
- Philippines FDA Announces New Requirement for All Medical Devices January 6, 2021
- Philippines FDA Alters Requirements for Radiation Licensing During COVID-19 December 17, 2020
- NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China December 16, 2020
- Indonesia e-Catalogue to Soon Open for 1,480 Medical Device Categories December 8, 2020
- New Advertising Exemption in Thailand November 30, 2020
- Sales Target Spotlight: China’s Boao Hope City November 24, 2020
- Vietnamese MOH Establishes New Medical Device Advisory Council November 20, 2020
- China Regulatory and Commercial Updates November 4, 2020
- Indonesia Market Summary and Registered Devices Review October 23, 2020
Blogs by Country
実際の亞洲
เอเชีย แอคชวล
एशिया वास्तविक
실제 아시아
Asia Actual, LLC
515 Congress Avenue, Suite 2100
Austin, TX 78701
+1 512 898-9222
Contact Us
Privacy Policy
Asia Headquarters
116 Changi Road, #04-05
Singapore 419718
+65 3138-4148
India’s CDSCO Extends List of Notified Devices
/in India, Latest News /by Gunjan VermaOn December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.
Philippines FDA Announces New Requirement for All Medical Devices
/in Latest News, Philippines /by Charmaine RosonOn January 4th, the Philippines FDA released FDA Circular 2021-002. This Circular outlines new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.
Philippines FDA Alters Requirements for Radiation Licensing During COVID-19
/in Latest News, Philippines /by Glend LlantadaFDA’s Circular No. 2020-035 will take into effect immediately, and will pertain to the conduct of licensing inspection for radiation facilities in particular.
NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China
/in China, Commercial Services, Hong Kong, Latest News /by Eric LeungMedical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
Indonesia e-Catalogue to Soon Open for 1,480 Medical Device Categories
/in Indonesia, Latest News /by Ilham HidayattulahThe Indonesia Ministry of Health recently announced that they will be opening the e-catalogue enrollment period and will soon begin accepting applications for 1,480 product categories.
New Advertising Exemption in Thailand
/in Latest News, Thailand /by Binh ThaiA Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.
Sales Target Spotlight: China’s Boao Hope City
/in China, Latest News /by Bryan GilburgThe Chinese national government has established a special economic zone on Hainan Island with a focus on medical devices and wellness. Medical device manufacturers seeking sales growth in China should be aware of the Boao Hope City development particularly those with new and innovative devices.
Vietnamese MOH Establishes New Medical Device Advisory Council
/in Latest News, Vietnam /by Bryan GilburgOn November 18, 2020, the Vietnamese Ministry of Health (MOH) released Decision No. 4353 / QD-BYT officially establishing an Advisory Council to help with the regulatory transition.