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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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Philippines Extends Grace Period for Registration of Certain Medical Devices
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA released a draft Circular announcing an extension of the grace period for certain medical devices by 12 months.
Thai FDA Streamlines Medical Device Registration Process
/in Latest Updates, Thailand/by Bryan GilburgThe TFDA will adjust the registration process and remove the initial pre-submission step beginning March 15, 2022. Beginning April 1, 2022, any classification and/or grouping questions can be submitted through a separate E-submission process for a 500 THB (US$15) fee each.
Thai FDA Updates List of Chemical Pollutants
/in Latest Updates, Thailand/by Bryan GilburgThe TFDA has updated their list of chemical pollutants to comply with the Stockholm Convention on Persistent Organic Pollutants.
Indonesia Revamps eCatalogue Procurement System
/in Indonesia, Latest Updates/by Ilham HidayattulahOn February 11th and 14th, the Ministry of Health of the Republic of Indonesia implemented significant structural and procedural changes to the government procurement system known as e-Catalogue as it applies to medical devices (reference announcement KN.01.04/3/630/2022). Under the new rules, oversight of the e-Catalogue has been moved under the Ministry of Health and will not require negotiations.
India’s CDSCO Expected to Begin Enforcing Local BIS Standards
/in India, Latest Updates/by Gunjan VermaOn 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.
India’s CDSCO Adds United Kingdom to List of Accepted Reference Countries
/in India, Latest Updates/by Gunjan VermaOn 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.
Asia Actual is the Best Medical Device Consulting Company in Asia
/in Australia, China, Hong Kong, India, Indonesia, Japan, Latest Updates, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, United States, Vietnam/by Todd DaigneaultManufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
India’s MOH Releases Draft Amendment to the Medical Device Rules 2017
/in India, Latest Updates/by Gunjan VermaOn 12th of January, the Ministry of Health and Family Welfare released the final notification outlining the new ISO 1385 requirements for medical device importers in India.