Malaysia Medical Device Conformity

In the first step, you discuss your company and the goals of an ISO 13485 certification with us. Based on these discussions, you will receive an individual quote tailored to the needs of your company or organization.

The assessment of your quality management system is carried out in stages using a system analysis (Stage 1) based on your QMS documentation and a subsequent on-site system assessment (Stage 2), in which an experienced assessor evaluates the effectiveness of your processes for compliance with applicable requirements. The res ults are presented to you at a final meeting, along with the next steps on the path to their certification. You will receive a detailed report summarizing the results once the next step certification decision has been made.

Full Conformity assessment require  Establishment submit full technical documents according to Common Submission Dossier Template CSDT. An assessor that approved by MDA with relevant MD code evaluate for compliance with applicable requirements. The results are documented , you will receive a details report once the next step certification decision has been made.    

For medical devices that have undergone conformity assessment and approval for placement in the market of the recognised countries by MDA ie TGA Australia, Health Canada, CE from Europe, MHLW Japan, FDA USA, and other foreign medical device authority or notifying bodies to be determined by MDA from time to time, it only needs to undergo simpler conformity assessment which is thru Technical Documents Verification. An assessor that approved by MDA evaluate submitted technical documents for compliance with applicable requirements. The results are documented, you will receive a details report once the next step certification decision has been made.   

The results from your system assessment are evaluated by an independent panel of experts, who confirm or reject the assessor's certification recommendation. If there are any questions regarding the content, we will contact you.

If you can prove that all requirements have been met, you will then receive your DQS certificate.

In order to maintain your certification, we must carry out annual surveillance audits for the case of ISO 13485 or GDPMD.

Should there be any changes to your quality management system within a certification cycle, we will adapt our surveillance activities accordingly and include them in the audit cycle.

A certification according to ISO 13485 or GDPMD has a maximum validity of three years, but you can seamlessly combine it with a subsequent audit cycle by applying for recertification.

Whilst for Full Conformity assessment or Technical Documents Verification, there is no on going surveillance activities unless changes of medical devices, and these certificates has a maximum validity of five years.