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Asia Pacific

Set Alert for Asia Pacific Policy and Regulation

Asia Reg Roundup: Malaysia, Vietnam & India Speed Ahead In 2017

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.

Asia Pacific Regulation Vietnam
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Latest From Asia Pacific &Policy & Regulation

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

Register Again Or Not? Malaysia Clarifies What Companies Must Do When They Modify A Device

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.

Asia Pacific Malaysia

India Can Do More To Align New Medtech Regulations With Global Norms, Says Industry

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.

Policy & Regulation Regulation

China Requires Medtech Cybersecurity Compliance Against Hackers

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.

China Digital Health
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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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