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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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Vietnam Extends Validity of Medical Device Import Licenses
/in Latest Updates, Vietnam/by David VoOn March 3rd, 2023, the Deputy Prime Minister of Vietnam, Tran Hong Ha, signed Decree No. 07/2023/ND-CP (Decree 07/2023), which automatically extended the validity of import licenses to December 31, 2024.
India Requires Mandatory Local BIS Certifications for Certain Medical Devices
/in India, Latest Updates/by Gunjan VermaThis blog serves as an important enforcement notice for manufacturers/importers that BIS certification is required for some of the electronic components/accessories included in medical devices, including batteries, monitors, power adaptors and more.
Thai FDA Issues Guidance on Specialist Review Selection Criteria
/in Latest Updates, Thailand/by Noi SuwannabotGet the latest insights on the Specialist Review Guidance for medical device registration in Thailand from the Thai FDA. Learn about the criteria that trigger a Specialist Review and how to potentially avoid it.
Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies
/in Latest Updates, Philippines/by Charmaine RosonThe Philippines FDA has issued a new report entitled “Guidelines on the Food and Drug Administration’s Regulatory Responses During Declared National or State Public Health Emergencies.”
Hong Kong Refines Medical Device Post-Market Surveillance Report Form
/in Hong Kong, Latest Updates/by Albert PranotoOn December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.
Thailand FDA Provides Guidance on Classification of Physical Therapy Devices
/in Latest Updates, Thailand/by Noi SuwannabotOn December 3rd, 2022, the Thailand FDA (TFDA) issued new regulation to re-classify Physical Therapy Devices as Class 1 medical devices.
Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices
/in Latest Updates, Philippines/by Charmaine RosonOn December 29th, 2022 the Philippines FDA (PFDA) issued an advisory reiteration concerning unethical business practices, specifically in regards to companies that sell/manufacture Prescription Pharmaceutical Products and Medical Devices (PPPMD) and their relationship/interaction with healthcare professionals (HCPs).
Indonesia e-Catalogue Implementation Review, December 2022
/in Indonesia, Latest Updates/by Ilham HidayattulahOn April 7th, 2022, the Indonesian Ministry of Health announced a new open enrollment policy allowing manufacturers to list sales prices much easier. Under the new process, listings are accepted upon submission and published online as soon as the next day.