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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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