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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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India Temporarily Suspends Compulsory Medical Device Registrations
/in India, Latest Updates/by Gunjan VermaIn public notice F. No. 29/Misc/03/2021-DC (28), dated September 28, 2021, the implementation of Compulsory Registration, which was to be implemented and effective October 1, 2021, has been put in abeyance for few days as the Indian Ministry of Health determines whether to formally postpone the enforcement date.
VietNam Expedites Registration of COVID-19 Related Medical Devices
/in Latest Updates, Vietnam/by David VoWith the release of Circular 13/2021/TT-BYT on September 16, 2021, the VietNamese Ministry of Health has provided a new, expedited review process for specified medical devices related to COVID-19.
India to Require All Medical Devices be Registered Before Importation
/in India, Latest Updates/by Gunjan VermaOn September 21, 2021, the CDSCO released the Guidance Document for Registration of Non Notified Medical Devices to provide additional clarity as the Voluntary registration deadline approaches on September 30, 2021.
The Philippines FDA Releases List of VAT Exempt Therapeutic Products
/in Latest Updates, Philippines/by Glend LlantadaOn September 14th, the Philippines FDA released FDA Advisory No.2021-2293, outlining the list of VAT-Exempt Products pursuant to Republic Act No. 11534, otherwise known as the “Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act.”
Asia Actual Launches Online Medical Device Approval Search Service
/in Latest Updates/by Bryan GilburgAsia Actual is excited to launch R.O.S.E., the Registration Optimized Search Engine. The goal of R.O.S.E. is to provide centralized access to medical device registration data in Asian markets.
Philippines Releases New Guidance on Class A Medical Devices
/in Latest Updates, Philippines/by Charmaine Rosonthe FDA has released a list of Class A 1,242 product categories in Circular 2021-017 on August 16, 2021. Medical device manufacturers of Class A products specified in Annex A or under the ASEAN MDD, must obtain a Certificate of Medical Device Notification (CMDN).
Philippines Extends Grace Period for Non-Notified Class B, C, and D Medical Device Registration
/in Latest Updates, Philippines/by Charmaine RosonDuring this transition period, Class B, C, and D medical devices that are not included in the specified list in Circular No. 2021-001-A may continue to be manufactured, imported/exported, distributed, and/or sold without a CMDN until March 31, 2022.
Indonesia Freezes Government Purchases of 79 Categories of Imported Medical Devices
/in Indonesia, Latest Updates/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.