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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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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.
India 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).
India Adds First Medical Device to Price Control System
/in India, Latest Updates/by AsiaActualAdminWith the publishing of the ‘Drug (Prices Control) third amendment Order, 2016’ on December 21, 2016, coronary stents were added the list of devices subject to government price controls. Included in the product definition are bare metal stents, metallic drug eluting stents, and bio-resorbable vascular scaffold/biodegradable drug eluting stents.
The Philippines FDA Publishes New Guidance on Medical Device Recalls
/in Latest Updates, Philippines/by AsiaActualAdminThe Philippines Food and Drug Administration (FDA) has published a Circular clarifying medical device recall requirements referenced in sections 5 (k) of the FDA Act of 2009. The requirements will go into effect in September of 2016.