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- China Continues to Implement UDI of Medical Devices with Third Batch Release March 16, 2023
- USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices March 7, 2023
- Vietnam Extends Validity of Medical Device Import Licenses March 7, 2023
- India Requires Mandatory Local BIS Certifications for Certain Medical Devices February 22, 2023
- Thai FDA Issues Guidance on Specialist Review Selection Criteria February 16, 2023
- Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies February 7, 2023
- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
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Philippines FDA Issues New Draft IVD Regulations/in Latest Updates, Philippines/by Charmaine Roson
The Philippines FDA released new draft IVD guidance for the public’s review and comment in early January 2022 which would harmonize their regulations with the ASEAN Medical Devices Directive (AMDD).
India’s CDSCO Releases Draft Notice for Suspending or Cancelling Import Licenses/in India, Latest Updates/by Gunjan Verma
Prior 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 Roson
Products 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 Leung
Hong 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 Rasiklal
Singapore’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 Verma
UDI 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 Hidayattulah
On 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 Vo
All unapproved Class B, C and D MA License applications have been returned for resubmission for compliance to the new requirements.