MDA MEDICAL DEVICE CERTIFICATION SCHEME

medicel-2016

DQS – THE CONFORMITY ASSESSMENT BODY (CAB)

The Malaysian Medical Device Act 2012 was gazetted on 9th February and with effective from 1st July 2013. A transition period was given to the industry for compliance before full enforcement from the authority in 2014. The Act specifies requirements for medical device product registration, establishment licensing and conformity assessment body (CAB) registration to ensure the safety of the medical device and protection of public health and safety.

The Medical Device Regulations 2012, the subsidiary legislations under the Medical Device Act 2012, was approved by the Minister of Health and published in the Gazette on 31st December 2012.

The Regulations specify requirements and procedural matters pertaining to medical device registration, conformity assessment body (CAB) registration, establishment licensing, export permit and appeal.

The Regulations were enforced simultaneously with Medical Device Act 2012 on 1st July 2013. And as specified in Medical Device Act 2012, a transition period of two years for medical device registration and one year for establishment licensing were given to the industry before it is fully enforced.

DQS is the registered conformity assessment body with MDA and approved to perform verification & conformity assessments for medical devices against the product related requirements of the regulations.

DQS is also approved to assess the Quality management system appropriate with role and function of the establishment and comply with requirements. Prior to the placement of the device on market, establishment is mandated to get establishment license from MDA. The pre-requisite requirement is to obtain the ISO 13485 certification (for the manufacturer) or GDPMD certification (for the authorised representative, importer, distributor or warehousing) from the approved Conformity Assessment Body (CAB). The said management system certifications are valid for 3 years.

Medical Device Supply-Chain

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In addition, DQS is also a MDA approved assessment provider to conduct product conformity assessment by reviewing and verification of the evidence of the medical devices that have been assessed and approved by foreign regulatory authorities or notifying bodies recognized by MDA. Certificates with 5 year validity will be issued after upon successful completion of audits and approval from independent technical reviewer.

The product registration deadline has been extended until 30th June 2016. DQS is actively providing its customized services in product verification & product conformity assessments in order to support the industry to register the medical devices to meet the deadline mentioned.

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