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- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
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India’s CDSCO Releases Draft Notice for Suspending or Cancelling Import Licenses
/in India, Latest Updates/by Gunjan VermaPrior to this draft notification, there was no explicit rule providing clarity about the cancellation or suspension regarding the import License in case of any violation of the conditions by the license holder while such provisions were included for a manufacturing license in the MDR 2017.
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.