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- Singapore HSA Regulations on Hand Sanitizers, Masks, Thermometers, and Protective Gear January 22, 2021
- Vietnam to Require Annual Inspection of Certain Medical Equipment January 15, 2021
- India’s CDSCO Extends List of Notified Devices January 13, 2021
- Philippines FDA Announces New Requirement for All Medical Devices January 6, 2021
- Philippines FDA Alters Requirements for Radiation Licensing During COVID-19 December 17, 2020
- NMPA to Pilot Program Allowing Hong Kong Approved Products to Be Sold in Mainland China December 16, 2020
- Indonesia e-Catalogue to Soon Open for 1,480 Medical Device Categories December 8, 2020
- New Advertising Exemption in Thailand November 30, 2020
- Sales Target Spotlight: China’s Boao Hope City November 24, 2020
- Vietnamese MOH Establishes New Medical Device Advisory Council November 20, 2020
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Singapore HSA Regulations on Hand Sanitizers, Masks, Thermometers, and Protective Gear
/in Latest News, 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 News, Vietnam /by Binh ThaiOn 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 News /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 News, 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 News, 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 News /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 News /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 News, Thailand /by Binh ThaiA 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.