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- China Releases New List of Standards for Medical Device Registration July 26, 2024
- 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
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Philippines Proposes New Fees for Medical Device Registration
/in Latest Updates, Philippines/by Glend LlantadaThe Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.
India to Regulate More Medical Devices
/in India, Latest Updates/by Bryan GilburgAt the May 16th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed that expands the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India. The following device categories are affected:
Philippines Announces New Medical Device Regulations
/in Latest Updates, Philippines/by Bryan GilburgIndonesia the Next to Takes Steps Toward ASEAN MDD Harmonization
/in Indonesia, Latest Updates/by Bryan GilburgIndia to Require Ultrasound and Imaging Equipment to be Registered with the CDSCO
/in India, Latest Updates/by Bryan GilburgNew Regulations in India Raise the Bar for Many IVD Devices
/in India, Latest Updates/by Bryan GilburgThe new Medical Device Rules, 2017 that took effect January 1, 2018 significantly expands the number of IVD devices requiring full technical documentation in support of their Import License applications.
Indonesia Publishes Guidelines for Clinical Trail Approvals for Medical and Diagnostic Devices
/in Indonesia, Latest Updates/by Bryan GilburgThe Philippines FDA Streamlines Amendment Submission Process
/in Latest Updates, Philippines/by Bryan GilburgOn December 15, 2017 the FDA released guidance that provides for streamlining of the submission process for CPR amendments.