Authorize Representation Service

Authorize Representation Service by Rocky Consulting.

Further to the implementation of the Medical Device Act ,  All medical Exporters to Malaysia must appoint an Local Authorize Representative , The scope for the LAR is basically to Prepare and Submit all relevant documents with regards of product registration to the Medical Device bureau.

Rocky Consulting can fully act as your Local Authorized Representative and meet all the obligations of this important role. Most importantly is for the Multiple Importers of Device from the same prinicipal.

Here , We can Act as an LAR and also appoint the company to be importers in this kind of cases which will avoid any mis communications between the Importers and Principal.

Malaysia Authorized Representative Responsibilities

As in many other markets, Local Authorize representative is your regulatory liaison with the Malaysian Medical Device Bureau  and is responsible for managing your medical device registration. The Local authorized representative you select must be a citizen or permanent resident of Malaysia.

Once appointed, your Malaysia Authorized Representative will submit all necessary medical device registration documents to CAB’s if classified between Class B- Class D for  conformity assesment and alert you to address any questions from regulators about your submission. With our local presence in Malaysia, we have the expertise and resources to perform all duties required to be your Local Authorized Representative.

To meet the criteria of becoming the Local Authorize Representative Rocky Scientific Has also Undergo the GDPMD ( Good Distribution Practise for Medical Device ) , Carrying the scope of  LAR for Medical Device which were certified by BSI Services Malaysia on 29th May 2014

Can the Distributor Be the Local Authorized Representative in Malaysia?

Off Course Can..Many medical device manufacturers consider the option of appointing their distributors as their authorized representatives, so easy for them to monitor. However, having an independent local authorized representative assisting with your product registration in Malaysia will be very helpful

Some key reasons we recommend selecting an independent company as your Malaysia Authorized Representative include:

  • You may have to provide proprietary or sensitive information about your medical device to your Malaysia Authorized Representative during regulatory review of your registration. Some manufacturers would prefer not to divulge such information to their distributors.
  • If a product recall of your medical device then we as your regulatory consultant will lead the activity by liasing with the principal until the rootcause and all relevant documents submitted to the AUthority
  • We will keep our Client  informed of new and changing regulatory issues.
  • A professional, independent authorized representative would be committed solely to ensuring your firm stays ahead of regulatory requirements in Malaysia.

Currently we serve as AR for ,


Occlutech , Sweden

Please contact us for more information on how we can act as your Malaysia Authorized Representative.