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- China Continues to Implement UDI of Medical Devices with Third Batch Release March 16, 2023
- USAID, ANSI and AdvaMed Host Regional Virtual Workshop on Good Regulatory Practices March 7, 2023
- Vietnam Extends Validity of Medical Device Import Licenses March 7, 2023
- India Requires Mandatory Local BIS Certifications for Certain Medical Devices February 22, 2023
- Thai FDA Issues Guidance on Specialist Review Selection Criteria February 16, 2023
- Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies February 7, 2023
- 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
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India Sets Price Limits for Coronary Stents (other devices to follow)/in India, Latest Updates/by AsiaActualAdmin
India’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 AsiaActualAdmin
The 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 AsiaActualAdmin
India Launches New Medical Device Regulations/in India, Latest Updates/by AsiaActualAdmin
Last 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 AsiaActualAdmin
With 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.
Comprehensive Medical Device Regulations Coming to India/in India, Latest Updates/by AsiaActualAdmin
The Indian Central Drugs Standard Control Organization (CDSCO) took another step closer to implementing comprehensive medical device regulations. On October 18th, a draft of the ‘Medical Device Rules, 2016’ was formally published for public comment. These Rules are similar to those informally circulated in July to industry stakeholders. A link to the document is available here on the Asia Actual website (the English version starts on page 145).
The Philippines FDA Publishes New Guidance on Medical Device Recalls/in Latest Updates, Philippines/by AsiaActualAdmin
The 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.
The Philippines FDA No Longer Requires Physical Samples for Medical Device Registration/in Latest Updates, Philippines/by AsiaActualAdmin