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MALAYSIA: Raminder Notice on the Complete Enforcement of Requirements for Registration of Medical Device - July 2018

MALAYSIA: Raminder Notice on the Complete Enforcement of Requirements for Registration of Medical Device - July 2018

  • 2020-02-13 06:23:56

MDA has released a Circular Letter at the end of May 2018 as a reminder notice on the complete enforcement of requirements for registration of medical device under Section 5 of Medical Device Act 2012 (Act 737), whereby no medical device can be allowed to be imported, exported or marketed in Malaysia unless it has been registered with MDA, according to this Act.

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CHINA: CNDA and Hainan Government Collaboration to Speed Up the Registration Process of Medical Devices Needed for Emergency Situations – May 2018

CHINA: CNDA and Hainan Government Collaboration to Speed Up the Registration Process of Medical Devices Needed for Emergency Situations – May 2018

  • 2020-02-14 07:32:41

The Council decides to suspend the implementation of Clause 11 of the Medical Device Registration and Management in the Hainan tourism area. In order to support this suspension, CNDA has released a temporary Order, entitled “The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. The scope of this Order includes all medical devices that are urgently needed for clinical purposes, operation conditions, and a

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 MALAYSIA: New Regulation Issued on Licensing and Medical Device Registration for Original Equipment Manufacturer (OEM) - April 2018

MALAYSIA: New Regulation Issued on Licensing and Medical Device Registration for Original Equipment Manufacturer (OEM) - April 2018

  • 2020-02-14 07:45:46

The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.

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