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- 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
- India’s Class C and D Import License Enforcement Deadline Fast-Approaching February 20, 2024
- Thai FDA QMS Updates to Affect GDP, GMP, and GCP February 14, 2024
- Hong Kong MDD Adds China and Korea to List of Reference Countries January 29, 2024
- Thailand FDA to Decrease Registration Application Processing Times January 25, 2024
- Thailand FDA to Improve Medical Device Advertising Review Times January 22, 2024
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Indonesia Medical Device e-Catalogue Enrollment: 2018 Debrief
/in Indonesia, Latest Updates/by Bryan GilburgIndia to Regulate Glucometers, Blood Pressure Monitors, Nebulizers and Digital Thermometers
/in India, Latest Updates/by Bryan GilburgAt the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.
Indonesia Tightens Enforcement of Medical Device Licensing
/in Indonesia, Latest Updates/by Bryan GilburgWith the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.
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 Gilburg