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Asia Pacific

Set Alert for Asia Pacific Policy and Regulation

Australia’s TGA Overrides Industry Concerns Over Publishing Priority-Review Pathway Decisions

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.

Review Pathway Australia Policy & Regulation
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US Trade Rep May Take Enforcement Actions Against India Over Device Price Controls

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.

Cardiology Trade

Number To Know…300

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.

Australia Number to Know

Industry Supports Introduction Of Australian Notified Bodies, But With Conditions

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.

Australia Europe

Global Medtech Guidance Tracker: May 2017

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.

Regulation Medical Device

Asia Reg Roundup: Cybersecurity, China, ASEAN And MDSAP Updates

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.

Asia Pacific Regulation

Malaysia Outlines Requirements For Issuing Export Permits

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.

Regulation Malaysia
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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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