Local Authorised Representative for in-country representation in Southeast Asia
Let Andaman Medical be your trusted Local Authorized Representative to represent your medical device in the ASEAN region
“If the medical device manufacturer is not present in Malaysia, it shall authorize an authorized representative to act on its behalf with regard to the conduct of the conformity assessment.”
As the Malaysia Medical Devices Regulations 2012 do not include a detailed description of the role and obligations of a local authorized representative it is of vital importance to both the manufacturer and the local agent representative to set up a contract specifying the task and authority the manufacturer will delegate to the authorized representatives.
The appointment of a local authorized representative does not change the responsibilities of the manufacturer. The local agent representative must be duly selected and supervised by the manufacturer.
What is our role as your Local Authorized Representative (LaR)?
- To ensure that the appropriate conformity assessment procedure has been carried out, that the medical device is correctly labeled and that information is provided in the specified national language.
- To maintain a place of business including a telephone, email and fax connection within the country during the term of the agreement or any renewals thereof.
- To assist the medical device company in filing establishment licenses and/or medical device product registrations that meet the local medical device authority (MDA) requirements and identifies the LAr as the local authorized representative for the medical device company.
- To accept all calls from the MDA regarding the medical device company or its products and to report to the company, within two business days (recognized public holidays excluded).
- To assist the medical device authority in communications with the company.
- To respond to questions, either by direct response or by a commitment to the MDA to provide a timely response following consultation with the medical device company, regarding products that are imported or offered for import
- To liaise between the medical device authority and the company in scheduling inspection(s) of the facilities of the company’s facilities (if required)