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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 FDA to Expedite Applications Approved Under AMDD-CSDT
/in Latest Updates, Philippines/by Charmaine RosonProducts approved under AMDD harmonized regulation with CSDT documentation are now eligible for an expedited review by the Philippines FDA.
Hong Kong’s MDD Formalizes Expedited Approval Scheme
/in China, Commercial Services, Hong Kong, Latest Updates/by Eric LeungHong Kong’s Expedited Approval Scheme has been upgraded from a trial. Approvals from at least 2 GHTF countries plus China.
Singapore’s HSA to Increase Fees in July 2022
/in Latest Updates, Singapore/by Kenna RasiklalSingapore’s Health Science Authority (HSA) to increase review fees in July 2022 by about 3%.
India’s CDSCO Temporarily Delays Implementation of UDI Requirements
/in India, Latest Updates/by Gunjan VermaUDI requirements in India were supposed to begin January 1, 2022 but have been delayed temporarily and expected to be based on IMDRF guidance.
Indonesia to Permit Some Class A Products to Register via Notification
/in Indonesia, Latest Updates/by Ilham HidayattulahOn January 10, 2022, Indonesia’s Ministry of Health released Indonesia Class A Notification Announcement 01.05500242022 establishing a new registration route for some low risk medical devices effective immediately.
Vietnam Requires Resubmission of Many Medical Device Registration Applications
/in Latest Updates, Vietnam/by David VoAll unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.
China to Accept Foreign Generated Test Reports
/in China, Latest Updates/by Bryan GilburgThis adjustment will not only make the registration process cheaper and quicker for many manufacturers, it will also improve the efficiency of China’s labs to perform testing for domestic manufacturers and other devices that will still need in-country testing. While the regulatory burden for what the NMPA will consider as acceptable self-test reports is still high, this change provides manufacturers with more options.
India Postpones Registration Requirements for Certain Medical Devices
/in India, Latest Updates/by Gunjan VermaWith the release of a new order on Nov 3, 2021, CDSCO has postponed the Import Licensing requirement for 8 categories of medical devices.