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- Innovative Medical Device Registration in Japan April 30, 2024
- Medical Device Consultation in Japan April 30, 2024
- Australia’s SaMD Regulatory Deadline April 16, 2024
- Thai FDA Regulatory Documentation Exemptions April 12, 2024
- Hong Kong MDD Adds Singapore as Reference Country April 4, 2024
- Philippines Incentivizing Local Medical Device Manufacturing March 19, 2024
- China’s Third Batch of UDI Implementation Deadline in June March 15, 2024
- Thai FDA Reduces Application Review Time March 13, 2024
- Vietnam’s MoH Updates Class C and D Application Requirements February 29, 2024
- India Changes Medical Device Application Processing System February 27, 2024
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Invoicing Requirements for Medical Device Software in India
/in India, Latest Updates/by Gunjan VermaIndia is considered a high tax environment with complex requirements, with tax law being in a state of constant change. For those concerned with SaMD invoicing, the process may be complex.
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.