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Singapore regulators have clarified how they classify and regulate telehealth medical devices.
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.
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.
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.
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.
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.
Only marketing applications submitted on or after Aug. 22 will be considered for Singapore’s new priority-review scheme for medical devices.
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