Loading...
In Country Representation 2018-01-12T15:31:40+08:00

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 your medical device company does not have a physical location in Southeast Asia, medical device market regulators will require that you appoint a Local Authorized Representative (or registrant) to act as your liaison with the national authorities. Besides acting as a registrant in Singapore, Andaman Medical is a registered Local Authorized Representative in Malaysia and obtained GDPMD certification from TUV SUD. With our unique combination of regulatory experience and local expertise, we will be at your side as your local agent representative to support your success in the ASEAN markets.

Our GDPMD Certification

“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.”

Malaysia Medical Devices Regulations 2012

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)

Local Authorized Representative – FAQ

A manufacturer who places a medical device in a foreign market often have to designate a local authorized representative if they do not have a registered place of business in the country.
While the appointment of a local agent representative does not change the responsibilities of the manufacturer, the local authorized representative must be duly selected and supervised by the manufacturer. Regulations do not include a detailed description of the role and obligations of a local authorized representative so it is of vital importance to both the manufacturer and the local agent representative, to set up a contract specifying the tasks and authorities the manufacturer will delegate to the local authorized representative.

Appointing an independent LaR will save you time and money. Here are some questions to ask yourself as a manufacturer before making a decision:

  • Should my distributor focus on sales & marketing or on regulatory affairs?
  • Do I have to scrap all my labels, inserts and packaging if I want to change to another distributor (who is also my LaR)?
  • In case of incident, would the incident be analysed and reported diligently?
  • If my distributor is unable to answer the regulatory authority’s questions, does anyone in my company have the skills to do so directly?
  • Will confidentiality be maintained when sharing a dossier containing technical information with my distributor?
  • Will my distributor stay up to date on regulatory changes and provide me with timely warning when changes affect my devices?

Selecting a suitable LaR can be a challenging task, here are some criteria to consider:

  • Does the local agent representative maintain a place of business in the targeted country?
  • Does the local agent representative hold the appropriate license(s)?
  • Does the local agent representative have experience with medical devices?
  • Does the local agent representative have experienced regulatory staff?
  • Does the local agent representative have experience with incident analysis & reporting?
  • Does the local agent representative have a quality system in place?
  • Does the local agent representative have a post-market surveillance system in place?
  • What happens if I want to change to another local agent representative in the future?