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- India Grants Import License Grace Period for Class A/B Devices September 30, 2022
- India Issues Draft Notification for Exempting Certain Class A Medical Devices September 29, 2022
- Transfer of Product Registration of Alcohol Swabs from CDRRHR to CDRR September 14, 2022
- Vietnam’s DMEC Provides Update on Issuance of C/D Licenses September 14, 2022
- Philippines FDA Publishes Revised Draft of New IVD Regulations September 9, 2022
- Taiwan’s New TCP III in Effect as of January 1, 2022 August 31, 2022
- Hong Kong to Pilot Prioritizing Some Listed Medical Devices August 30, 2022
- How New EU MDR Requirements Will Affect Registrations in Asia August 12, 2022
- Thai FDA Implements Initial Screening Step to Submission Process August 7, 2022
- Indonesia Issues New Guidance for Freezing Medical Devices on eCatalogue August 5, 2022
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Thai FDA Implements Initial Screening Step to Submission Process
/in Latest News, 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 News/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 News, 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 News/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 News/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.
Philippines’ FDA Issues Customs Clearance Guidance for Radiation Products
/in Latest News, 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 News, 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 News/by Bryan GilburgRecently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.