APPLICATION FOR CLASS A MEDICAL DEVICE REGISTRATION

APPLICATION FOR CLASS A MEDICAL DEVICE REGISTRATION

Circular Letter of the Medical Device Authority No. 3 Year 2014 : Exemption of Medical Device from Registration Requirements has provided an administrative exemption from registration for Low Risk Class A Medical Device (supplied non-sterile, has no measuring function, non-active) only. This exemption is given subject to Medical Device Authority (MDA) being notified before MDA issues a letter of no objection to permit the importation and/or to be placed in the market.

 

However, to ensure adherence to the Medical Device Act 2012 (Act 737), The Minister of Health has considered an exemption for all Class A medical devices from the conformity assessment procedures by a conformity assessment body. The Medical Device (Exemption) Order 2016 has been gazetted on 18th April 2016.

 

Hence, the Circular Letter of MDA No. 3 Year 2014 will no longer effective and from 18 April 2016 following the gazettement date, MDA has stopped accepting Low Risk Class A Notification (LRCA).

 

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