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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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Singapore HSA Regulations on Hand Sanitizers, Masks, Thermometers, and Protective Gear
/in Latest Updates, Singapore/by Kenna RasiklalHand sanitizers are not considered medical devices and therefore, do NOT need approval from the Health Sciences Authority (HSA) in Singapore.
Vietnam to Require Annual Inspection of Certain Medical Equipment
/in Latest Updates, Vietnam/by David VoOn December 31st, 2020, the Ministry of Health (MoH) issued Circular No. 30/2020 providing a list of medical equipment subject to annual safety inspections and technical capability assessments, along with the timelines for implementation.
India’s CDSCO Extends List of Notified Devices
/in India, Latest Updates/by Gunjan VermaOn December 28th, 2020, the Central Drugs Standard Control Organization announced that Nebulizers, Blood Pressure Monitoring Devices, Digital Thermometer, and Glucometers must obtain Import Licenses prior to marketing.
Philippines FDA Announces New Requirement for All Medical Devices
/in Latest Updates, Philippines/by Charmaine RosonOn January 4th, the Philippines FDA released FDA Circular 2021-002. This Circular outlines new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.
Philippines FDA Alters Requirements for Radiation Licensing During COVID-19
/in Latest Updates, Philippines/by Glend LlantadaFDA’s Circular No. 2020-035 will take into effect immediately, and will pertain to the conduct of licensing inspection for radiation facilities in particular.
NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China
/in China, Commercial Services, Hong Kong, Latest Updates/by Eric LeungMedical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
Indonesia e-Catalogue to Soon Open for 1,480 Medical Device Categories
/in Indonesia, Latest Updates/by Ilham HidayattulahThe Indonesia Ministry of Health recently announced that they will be opening the e-catalogue enrollment period and will soon begin accepting applications for 1,480 product categories.
New Advertising Exemption in Thailand
/in Latest Updates, Thailand/by Bryan GilburgA Notification Published by the Thai Ministry of Public Health on November 2, 2020 exempts medical device manufacturers from the previous requirements regarding advertising approval in Thailand.