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- Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices July 7, 2021
- Philippines Announces New PEMDL Essential Medical Device List June 30, 2021
- Russia and Euro-Asian Neighbors Expected to Transition to EAEU Regulations in 2022 June 28, 2021
- India’s Public Hospitals Advised to Purchase Local Products June 15, 2021
- India Announces New Notified Medical Devices Now Requiring Import Licenses June 14, 2021
- VietNam’s MOH to Require CSDT Documentation for Class B, C, and D Devices May 24, 2021
- Thai Requirements for COVID Test Kits May 19, 2021
- India Exempts COVID Test Kits Approved in Reference Countries from Validation Testing May 18, 2021
- Regulatory Spotlight: UDI Requirements in Singapore May 14, 2021
- Taiwan FDA Increases Regulatory Fees for Medical Devices May 13, 2021
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Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices
/in Indonesia, Latest News /by Ilham HidayattulahPer Presidential Regulation 12/2021, the Ministry of Health (MOH) is requiring products with a Domestic Component Level (TKDN) and Benefit Weigh Value (BMP) of 40% or more be purchased by government hospitals regardless of available foreign products.
Philippines Announces New PEMDL Essential Medical Device List
/in Latest News, 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.
Russia and Euro-Asian Neighbors Expected to Transition to EAEU Regulations in 2022
/in Latest News, Russia /by Bryan GilburgWith the release of Decree 142, the Russian government has provided a roadmap for their transition to the new EAEU medical device regulations beginning January 1, 2022. After this date, all applications submitted must adhere to the EAEU rules which can vary significantly from the current Russian requirements.
India’s Public Hospitals Advised to Purchase Local Products
/in India, Latest News /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 News /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 News, 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 News, 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 News /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