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Asia Pacific

Set Alert for Asia Pacific Policy and Regulation

New Combination Product Registration Rules Coming To Malaysia

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.

Combination Products Review Pathway Malaysia

Latest From Asia Pacific &Policy & Regulation

Japan’s New 'Fast-Break Scheme' To Reduce Clinical Trial Burden For Medtech

Japan’s “fast-break scheme” is coming soon and will be the country’s fourth procedure for accelerating the approval of important medical devices.

Approvals Clinical Trials

India Issues Alert On Abbott’s Absorb But Xience Is Mainstay

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.

India Cardiovascular

Single Marketing Application Review For Multiple Jurisdictions On Horizon

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.

Asia Pacific Europe

China To Get Tougher On Recalls Beginning In May

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.

Recalls China

Device Registries In Asia-Pacific/MENA Needed As Focus On Real-World Data Grows

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.

Reimbursement Health Technology Assessment

Inside Look: Changes Ahead For The International Clinical Investigations Standard

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.

Medical Device Regulation
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Latest From Asia Pacific &Quality Control

More Manufacturers Sign Up For Single Audits As MDSAP Becomes Operational

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.

Quality Control Compliance

China Proposes Stricter Rules And Higher Penalties For Recalls

The China Food and Drug Administration wants to expand the scope of products subject to recall and increase the penalties for wrongdoers.

China Quality Control

China Clinical Data Crackdown Sees Device-Makers Withdraw 101 Applications

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.

China Regulation

Korea Moves To Halt Reuse Of Disposable Devices Amid HCV Outbreak

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.

Quality Control South Korea

Warning Letter Roundup & Recap – Aug. 16, 2016

FDA finds QS and marketing violations at a host of international device-makers. FDA released warning letters to 14 device companies this week.

Policy & Regulation Quality Control

Warning Letter Close-Outs – July 2016

Five device-related close-out letters were released by US FDA in July.

Policy & Regulation Medical Device
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