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Australia’s Therapeutic Goods Administration published a summary of changes it made to its coming priority-review pathway, following a public consultation on the initiative.
US Trade Representative Robert Lighthizer told Senate Finance Committee Chairman Orrin Hatch, R-Utah, that if India's ongoing practices to impose price controls on US device imports continue, he would consider "enforcement actions," if India's actions violated any World Trade Organization trading rules.
The Australian Therapeutic Goods Administration receive around 300 applications each year for medical devices to be audited and registered for sale in the country. But the introduction of Australian-designated notified bodies should help alleviate some of this burden.
Industry should not have to pay for the cost of designating Australian notified bodies, according to feedback to the Therapeutic Goods Administration’s consultation on introducing such organizations.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. In the latest update, see documents posted in May 2017.
China is making additions to its medtech regulatory system, and Southeast Asian nations are making progress towards ratifying the regional Medical Device Directive. Meanwhile, cybersecurity, priority reviews and the Medical Device Single Audit Program are demanding attention regionally and globally, as ARQon consultant May Ng and Asia Regulatory Professional Association (ARPA) secretary Jack Wong report in this Asian regulatory update.
Malaysia’s regulatory agency has issued guidance explaining procedural and data requirements for medtech companies applying for export permits. The agency says it can issue these permits approximately within 20 working day subject to receiving a complete application and fee.
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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