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New guidance explains how Malaysia’s impending rules for registering combination products will work when they come into force in July 2018, and how much sponsors will have to pay to have their applications assessed.
Latest From Asia Pacific &Policy & Regulation
Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.
India has issued an alert on Abbott’s Absorb bioresorbable coronary stent, in the backdrop of certain safety signals flagged up in global clinical studies pertaining to the product. The Indian order advises patients and physicians to report adverse events “suspected to be associated” with the use of the product.
Medical device makers could get their products to markets around the world faster if plans for a single premarket review program by international regulators go ahead.
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.
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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