Search Our News
Latest Headlines
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
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 8800-3197
Philippines’ FDA Issues Customs Clearance Guidance for Radiation Products
/in Latest Updates, Philippines/by Charmaine RosonOn June 3, 2022, the Philippines’ FDA issued Circular No.2017-013-A: amendment To FDA Circular No. 2017-013, titled, “Guidelines On The Issuance of Clearance for Customs Release (CFCR) of Radiation Devices by the Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR).” The amendment updates the guidance to align FDA Circular 2017-013 with DOH AO 2018-0002 and to help clarify the Clearance for Customs Release (CFCR) requirements for the industry and at the Bureau of Customs (BOC) for radiation products.
What is CSDT Documentation?
/in Indonesia, Latest Updates, Malaysia, Philippines, Singapore, Thailand, Vietnam/by Bryan GilburgManufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”
China Publishes 9 Draft Guidelines for Registration of Medical Devices
/in China, Latest Updates/by Bryan GilburgRecently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.
NMPA Issues New Guidance for Medical Device Software in China
/in China, Latest Updates/by Bryan GilburgIn March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.
Singapore’s HSA Issues New Software as Medical Device (SAMD) Guidance
/in Latest Updates, Singapore/by Kenna RasiklalIn April 2022, Singapore’s Health Science Authority (HSA) issued new guidance for registering software as a medical device (SAMD) and Clinical Decision Support Software (CDSS) in Singapore.
China Fully Implements UDI Requirements for Class 3 Medical Devices
/in China, Latest Updates/by Bryan GilburgBeginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
Korea MFDS Implements Medical Device Monthly Reporting Requirements
/in Latest Updates, South Korea/by Sarah BaikThe Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.
Philippines FDA Bans Mercury-Added Products
/in Latest Updates, Philippines/by Charmaine RosonReleased on June 13, 2022, the Philippines FDA released FDA Circular No.2022-003 banning the manufacture and sale of mercury-added products including thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes.