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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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Philippines Announces New PEMDL Essential Medical Device List
/in Latest Updates, Philippines/by Charmaine RosonNotification AO 2021-0038 was released on June 11th, 2021 with the goal of creating a standardized system for determining and maintaining a database of essential medical devices, hereby known as the Philippine Essential Medical Device List (PEMDL). Additionally, the Medical Devices and Supplies Price Reference Index (MDSPRI) will also be established to provide more price transparency when it comes to medical devices in the Philippines.
India’s Public Hospitals Advised to Purchase Local Products
/in India, Latest Updates/by Gunjan VermaOn March 25, 2021, a notification was released specifying 19 more devices belonging to categories such as gloves, syringes, orthopedic products, x-ray machines, etc. that only local manufacturers could bid on.
India Announces New Notified Medical Devices Now Requiring Import Licenses
/in India, Latest Updates/by Gunjan VermaAfter the voluntary period ends on October 2021, all class A and B non-regulatory medical devices will have 12 months (i.e., by October 1st, 2022) to obtain an Import License. Class C and D devices will have 24 months (i.e., by October 1st, 2023) to meet the same requirement.
VietNam’s MOH to Require CSDT Documentation for Class B, C, and D Devices
/in Latest Updates, Vietnam/by David VoOn May 15, 2021, the VietNamese Ministry of Health (MOH) released new Guidance announcing Class B, C, and D devices will need to submit their applications in accordance with the ASEAN Common Submission Dossier Template (CSDT) format.
Thai Requirements for COVID Test Kits
/in Latest Updates, Thailand/by Binh ThaiSimilar to other markets in the region, manufacturers of COVID test kits will need to undergo in-country validation as part of the Class 4 Licensing process in Thailand.
India Exempts COVID Test Kits Approved in Reference Countries from Validation Testing
/in India, Latest Updates/by Gunjan VermaAs of April 27th, India’s CDSCO will allow COVID test kits with the following approvals to bypass in-country validation testing. Previously only tests approved by the USFDA (including Emergency Use Authorization) were exempt
Regulatory Spotlight: UDI Requirements in Singapore
/in Latest Updates, Singapore/by Kenna RasiklalSingapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system.
Taiwan FDA Increases Regulatory Fees for Medical Devices
/in Latest Updates, Taiwan/by Eric LeungThe Taiwan FDA has announced a price increase for many regulatory items, with some seeing an increase as much as 163%. This notice has been in effect since May 1st, 2021.