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
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.
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).
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.
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 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.
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