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- Hong Kong Refines Medical Device Post-Market Surveillance Report Form January 27, 2023
- Thailand FDA Provides Guidance on Classification of Physical Therapy Devices January 19, 2023
- Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices January 13, 2023
- Indonesia e-Catalogue Implementation Review, December 2022 December 30, 2022
- The Vietnamese MOH Issues Draft Decree to Address Delays December 14, 2022
- Thailand FDA Publishes Guidance for Software as Medical Device December 14, 2022
- China NMPA Updates Compulsory Standards for Medical Devices December 6, 2022
- China NMPA Updates Classification of Sodium Hyaluronate Products November 18, 2022
- India Issues Final Notice Exempting Certain Class A Medical Devices November 14, 2022
- China’s NMPA Publishes Classification Catalogue Adjustments for Comment November 8, 2022
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Tips for Importing Medical Devices into Thailand
/in Latest Updates, Thailand/by Bryan GilburgIndonesia 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.
Russia Streamlines Medical and IVD Device Regulations
/in Latest Updates, Russia/by Bryan GilburgOn the May 31st Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) published Decree No. 633 which includes provisions that significantly improve the registration process for medical and IVD devices. The changes go into full effect on June 13th, 2018.
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 Gilburg