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Asia Pacific

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Singapore Finalizes Telehealth Guideline; Immediate Registration Route For Mobile Apps To Follow

Singapore regulators have clarified how they classify and regulate telehealth medical devices.

Singapore Policy & Regulation Review Pathway
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Global Medtech Guidance Tracker: September 2017

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-eight new guidance documents were posted to the tracker.

Regulation Singapore

Australia Sees Surge In Level 3 Audits For Active Implantables

Australian regulators completed more Level 2 compulsory audits of applications to include class III and active implantable medical devices on the Australian Register of Therapeutic Goods in 2016-17.

Australia Approvals

Medtech Can Help India 'Leapfrog Health Care Constraints'

A new Deloitte report says medtech could help bridge the gap in India between the vast number of patients requiring health care and the small medical manpower available that’s led to a public health care crisis. However, the government needs to create a more conducive investment climate for medical device players to build this bridge.

Policy & Regulation India

OUS Approvals Analysis: Medtronic, MicroPort Lead August's Line-Up Of International Approvals

There were 16 CE marks and seven medical device approvals in regions outside of the US and EU in August, according to Medtech Insight's Approvals Tracker. Although 23 approvals in a month is below average for the 2017 OUS tracker, it's more than appeared in August 2016 or 2015, and keeps 2017 on track for 351 approvals from outside the US.

Approvals Innovation

Medtech Advised To Prepare For Significant Updates In China’s Classification Catalogue

Revisions to China’s classification catalogue have now been finalized and they will have considerable impact on device registration, according to law firm Ropes & Gray.

Policy & Regulation Review Pathway

Singapore’s Priority-Review Scheme Goes Live

Only marketing applications submitted on or after Aug. 22 will be considered for Singapore’s new priority-review scheme for medical devices.

Review Pathway Singapore
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