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April 12, 2018

Luctor et Emergo – a Canadian solution for the MDSAP implementation

The fact that Canada will depend only on the MDSAP program to cover their Regulatory QMS requirements after the end of this year is causing great challenges and issues for medical device manufacturer.
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April 11, 2018

Qserve Spotlight on Samuel Golub, Regulatory Team Member

Interview with Qserve's consultant Samuel Golub
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April 09, 2018

"Boao" a shortcut for innovative devices to enter into China?

BFA (Boao Forum for Asia Annual Conference) of 2018 is taking place as planned from April 8 to 11. On the first day of the forum, the State Council - China’s cabinet - announced the decision on suspending the implementation of the article 11, paragraph 2 of “the Supervision and Administration of Medical Device regulation” (Order 650) in the special area BMTPZ (Hainan Boao Lecheng International Medical Tourism Pilot Zone) for those devices with urgent need and without equivalent device within China.
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April 05, 2018

Update on China's MDR Order. 650

CFDA is asking public to comment revisions to China’s Medical Device Regulation Order. 650 in early November 2017, and would like to finalize it in 2018. Order. 650 sets the fundamental regulatory requirements and guidance for medical devices in China throughout their lifecycle.
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April 04, 2018

The new Silk Road – One Belt, One Road

Rollercoaster in regulatory science, that is perhaps how I could best describe the road to regulatory compliance in China for medical devices. 
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