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Progress on ratifying the ASEAN Medical Device Directive (AMDD) continues apace, with some of the Association of Southeast Asian Nations members surging ahead. Malaysia and Vietnam, in particular, are making big efforts to build or strengthen their national regulatory systems foe devices. Also, non-ASEAN state India is taking real steps in a similar direction, say Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng in this latest Asian regulatory update.
Latest From Asia Pacific &Policy & Regulation
More stringent recall rules in China will see the maximum penalty for failure to carry out a mandatory recall rise from three times the value of a medical device, to up to ten times its value.
Device industry groups are urging manufacturers and contract research organizations to get involved with an initiative to build medical device registries in Asia, the Middle East and North Africa, as regulators and reimbursement bodies in these regions increasingly focus on real-world data. They say stakeholders would be able to collaboratively assess this kind of data before any decisions were taken that could affect patient access to therapies.
Regulatory shifting sands the world over are complicating work on revising the international clinical investigations standard, ISO 14155. In this changing climate, it is important to keep requirements aligned. Danielle Giroud, founder of the World Medical Device Organization consultancy and founder/CEO of MD-CLINICALS, is convenor for the expert group (TC194 WG4) that is leading the revision. In this guest column, she explains how work is progressing.
New guidance from Malaysia’s Medical Device Authority defines three categories of device modifications and explains what they require of manufacturers in terms of notification to MDA.
India will finally get a device-specific regulatory framework when new rules formed by the government come into force next year. While the medtech industry has welcomed this long-awaited development, it hopes that its outstanding concerns will be addressed before the rules come into play.
China has issued its first-ever guidelines on cybersecurity in medical devices. These recommendations require companies to meet cybersecurity testing standards and ensure routine security updates before they can register web-connected products.
Latest From Asia Pacific &Quality Control
A growing number of medtech manufacturers have expressed interest in the Medical Device Single Audit Program since MDSAP became fully operational in January. The program has also drawn interest from regulatory agencies beyond those from the five participating countries, and a policy is being framed to admit new members.
The China Food and Drug Administration wants to expand the scope of products subject to recall and increase the penalties for wrongdoers.
China FDA is now relentlessly clamping down on clinical data irregularities in the medtech industry, causing 51 manufacturers, including well-known multinational companies such as Boston Scientific and Olympus, to withdraw more than a hundred new device approvals filed with the agency.
South Korean measures to root out the reuse of disposable medical devices amid a local outbreak of hepatitis C may have a positive impact on the industry, but the government still has some barriers to cross as industry participants are calling for more comprehensive measures.
FDA finds QS and marketing violations at a host of international device-makers. FDA released warning letters to 14 device companies this week.
Five device-related close-out letters were released by US FDA in July.
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