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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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Hong 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).
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.
Comprehensive Medical Device Regulations Coming to India
/in India, Latest Updates/by AsiaActualAdminThe 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 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.