MDA-CoRE or Medical Device Authority – Centre of Regulatory Excellence, will focus on the strategic development of Medical Device industry in Malaysia. This is an enhancement of the roles which was previously undertaken by Industrial Support Unit.

Objectives:

  1. To facilitate strategic development of local medical device industry
  2. To assist & develop competency related to medical device regulatory requirements
  3. To facilitate local manufacturer to market their products globally
  4. To facilitate harmonization of medical device regulatory requirement

Main activities:

  1. Consultation session to assist stakeholders to comply with regulatory requirements. Please Click Here for more details.
  2. Training packages based on regulatory requirement, guidance document or any other specific topics. Please Click Here for more details.

Contact:

Mr Dinesh Vijian

03-8230 0206

dineshv@mda.gov.my