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Asia Pacific

Set Alert for Asia Pacific

EAEU Medtech Agreement Will Have Upsides, But Manufacturers Must Plan Well

It might seem that the Eurasian Economic Union (EAEU) agreement on medical device regulation is nothing but administrative issues and slow progress, but it should deliver benefits to all stakeholders after launch, currently slated for 2022. but manufacturers need to be mindful of the member states' strengths and weaknesses when selecting their reference member state.

Kazakhstan Regulation Medical Device

India Strikes Pricing Blow To Knees After Stent Cuts

Six months after imposing stiff price controls on cardiac stents, India’s government slashed costs of knee implants by nearly 70%, saying the action was necessary to end “unethical profiteering.”

Orthopedics India

China's Latest Cybersecurity Proposal Could Heighten Scrutiny On Device, Drug Industries

Medtech and biopharma are among key information infrastructure industries likely subject to additional security and reporting obligations under draft legislation, adding costs and even potentially causing business disruptions, legal experts say.

China Cybersecurity

Eurasian Union For Medtech Gathers Pace, But Barriers Hamper Timely Completion

The transition deadline for adoption of Eurasian Economic Union (EAEU) medtech principles across the five member states remains the end of 2021, but vital elements are still not resolved, giving rise, for the first time, to notions of a delay in adoption. This would be the pragmatic course, local market experts believe, but for now, efforts are aimed at completing the system on time.

Russian Federation Regulation

Device Week – Global Regulations Update, Aug. 9, 2017

Want to know more about medtech regulatory efforts in countries from Singapore to Myanmar to Russia, and more in between? In this week's podcast, Ashley Yeo provides an update from his reporting on what governments in the Asia and Eurasia regions are doing to focus oversight on devices and diagnostics. The short answer: A lot.

Regulation Device Week

Medtech Associations Regulatory Networking, July 2017 – Singapore, the Philippines, Myanmar

The first Medtech Associations Regulatory Networking discussion, hosted by Medtech Insight and sponsored by the ARQon consultancy (Singapore) and the Asia Regulatory Professionals Association (ARPA), was held in mid-July. Updates were received from senior regulatory figures in three Asian medtech markets where regulation is evolving fast – Singapore, the Philippines and Myanmar.

Asia Pacific Regulation

Tighter Australian Rules Spell More Work For Surgical Mesh And Other Implant Makers

The Therapeutic Goods Administration wants feedback on planned changes that would align Australian medical device rules with the new medtech rules in Europe.

Australia Regulation
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Latest From Asia Pacific & Quality Control

Singapore Consults On Implementing New Device Distribution Standard

Singapore’s Health Sciences Authority is inviting feedback on a draft guideline to help medical device importers and wholesalers comply with its new standard on good distribution practice. The earlier technical specification on this topic will be phased out by 2020.

Regulation Quality Control

'Perfect Storm' Arrives: Clock Ticking For Device Firms To Conform To ISO 13485, MDSAP, EU & ASEAN Regs

Device manufacturers that haven't begun conforming to various ongoing international regulatory changes are behind the 8-ball and risk noncompliance, industry insider Kim Trautman says.

Regulation United States

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
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