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- 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
- Hong Kong MDD Adds China and Korea to List of Reference Countries January 29, 2024
- Thailand FDA to Decrease Registration Application Processing Times January 25, 2024
- Thailand FDA to Improve Medical Device Advertising Review Times January 22, 2024
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Thai FDA Implements Initial Screening Step to Submission Process
/in Latest Updates, Thailand/by Bryan GilburgBeginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.
Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue
/in Indonesia, Latest Updates/by Ilham HidayattulahOn July 6, 2022, the Ministry of Health released updated guidance outlining the process for freezing medical device categories on the eCatalogue,
Medical Device Advertising Requirements in Asia
/in Australia, China, Commercial Services, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Russia, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Bryan GilburgIn addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
Registering Innovative Medical Devices in India
/in India, Latest Updates/by Gunjan VermaInnovative device (those without a registered “predicate”) registration in India can be complicated with many variations to the requirements, and options to proceed.
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.