July 13, 2018
Medical devices to be registered in Malaysia must first undergo conformity assessment with a Conformity Assessment Body, to demonstrate its conformity to the requirements of medical device law. In regards to this, currently there are conformity assessment service with good quality and also comparable to global assessments or test carried out by local laboratories.
Thus, MDA has issued a Circular Letter on 22 May 2018, effective from the issuance date, which recognizes and lists institute or laboratory which is capable to carrying out clinical evidence or performance evaluation for the purpose of conformity assessment. This recognition and listing indirectly introduces and promotes local laboratories to the medical device industry. This recognition is one of the initiatives to facilitate the establishments to reduce cost and time to gather clinical evidence or performance evaluation of medical devices compared to overseas. This approach will also facilitate the local institutions or laboratories in its development, financial growth and recognition not only in Malaysia, but also globally.
Circular Letter No 3 Year 2018: Recognition and Listing of Institute or Laboratory Which is Capable to Carrying Out Clinical Evidence or Performance Evaluation for the purpose of Conformity Assessment