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- China Continues to Implement UDI of Medical Devices with Third Batch Release March 16, 2023
- USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices March 7, 2023
- Vietnam Extends Validity of Medical Device Import Licenses March 7, 2023
- India Requires Mandatory Local BIS Certifications for Certain Medical Devices February 22, 2023
- Thai FDA Issues Guidance on Specialist Review Selection Criteria February 16, 2023
- Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies February 7, 2023
- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
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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 Gilburg
In 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 Verma
Innovative 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 Gilburg
On 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 Roson
On 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 Gilburg
Manufacturers 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 Gilburg
Recently, 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 Gilburg
In 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 Rasiklal
In 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.