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- Key Takeaways from Vietnam’s CSDT Conference July 12, 2024
- Hong Kong Increases Prioritization of Registered Medical Devices July 12, 2024
- TGA Emphasizes Medical Device Distribution Record-Keeping July 10, 2024
- Singapore’s HSA Increases Medical Device Registration Fees July 2, 2024
- TGA Updates Rules for Medical Device Manufacturers June 25, 2024
- Software as a Medical Device in Thailand June 17, 2024
- Hong Kong Prepares Office for Mandatory Medical Device Regulations June 14, 2024
- Australia Issues New Guidance on AIMD and MLMD June 4, 2024
- India Extends Deadline for Class C and D Import Licenses May 28, 2024
- Indonesia Invests in Quality Healthcare Access May 22, 2024
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China Releases Draft Clinical Evaluation Exemption List for 2022
/in China, Latest Updates/by Bryan GilburgOn July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.
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.