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- CDSCO Issues Updates to IVD Classification List in India November 29, 2023
- Embracing Innovation and Collaboration: Highlights from the 15th CII Global MedTech Summit November 2, 2023
- Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS October 17, 2023
- India Grants Import License Grace Period for Class C/D Devices October 16, 2023
- Indonesia to Require Post-Market In-Country Testing of Medical Devices October 11, 2023
- China’s NMPA Updates Medical Device Classification Catalogue September 19, 2023
- Thai FDA Drafting New Guidance for SaMD and AI Device Registration September 18, 2023
- China NMPA Adds 47 Products to Clinical Trial Exemption List August 22, 2023
- New Plastic Waste (PWM) Rules Affect Medical Device Importers in India August 22, 2023
- China to Regulate Medical Device Advertising August 2, 2023
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INDIAN GOVERNMENT REMINDS MEDICAL DEVICE INDUSTRY OF PENDING REGULATORY CHANGES
/in India, Latest Updates/by Bryan GilburgExactly 6 months before the new Medical Device Rules, 2017 are to take effect the Drugs Controller General (India), Dr. G.N. Singh, published a notice that serves as a reminder to industry to prepare for the coming changes.
PHILIPPINES TO BAN POWDERED SURGICAL AND EXAM GLOVES
/in Latest Updates, Philippines/by Bryan GilburgWith FDA Advisory No. 2017-180 issued on June 20, 2017 the Philippines Food and Drug Administration (FDA) announced intentions to gradually switch to power-free gloves. A full ban of powdered surgical and examination glove will go into effect on January 1, 2019 effecting the importation, distribution and sale of specified devices.
MEDICAL DEVICE REGISTRATION FEES INCREASE IN KOREA
/in Latest Updates, South Korea/by Bryan GilburgHong Kong Legislature Considering Mandatory Medical Device Registration Requirements
/in Hong Kong, Latest Updates/by AsiaActualAdminIndia Sets Price Limits for Coronary Stents (other devices to follow)
/in India, Latest Updates/by AsiaActualAdminIndia’s National Pharmaceutical Pricing Authority (NPPA) moved swiftly and sharply to set the Maximum Retail Price (MRP) for coronary stents at INR7,260 (US$105) for bare metal stents and INR29,600 (US$440) for drug eluting stents and bioresorbable vascular scaffolds. T
Korea Intends to Increase Medical Device Registration Fees in 2017
/in Latest Updates, South Korea/by AsiaActualAdminThe Korean government has announced intentions to increase the official fees charged by the Ministry of Food and Drug Safety (MFDS) and Medical Device Information and Technology Assistance Center (MDITAC) for processing medical device conformity assessment applications.
Indonesia’s e-Catalogue System Overview
/in Indonesia, Latest Updates/by AsiaActualAdminIndia Launches New Medical Device Regulations
/in India, Latest Updates/by AsiaActualAdminLast week the Indian government officially published the Medical Devices Rules, 2017 providing for the comprehensive regulation of all medical and IVD devices in India. The Rules will come into full effect on January 1, 2018. A link to the document is available here on the Asia Actual website (the English version starts on page 143).