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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.
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.”
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.
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.
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.
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.
The Therapeutic Goods Administration wants feedback on planned changes that would align Australian medical device rules with the new medtech rules in Europe.
Latest From Asia Pacific & Quality Control
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.
'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.
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.
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