Malaysia Medical Device Conformity

The Malaysian Medical Device Act 737 requires a medical device to be registered before it can be imported, exported or placed in the market. DQS Malaysia is one of the approved Conformity Assessment Body by Malaysia Medical Device Authority to perform ISO 13485, GDPMD, Full Product Conformity and Technical Documents Verification under Act 737.

Process reliability through documented procedures

Proof of compliance with legal requirements

Increased product safety for patients and users

Increased customer and employee satisfaction

Highlighting the competence of the company


Medical Device Conformity

A quality management system forms the backbone for the activities and tasks of a medical device manufacturer. It ensures that internal and external regulations to be complied with are reliably taken into account and adhered to. Appropriate certification either through  ISO 13485, GDPMD, Full Conformity Assessment or Technical Documents Verification enables a manufacturer or AR or importer or distributor to build confidence in its processes and products and demonstrate its commitment to safety and quality.


Firm or company registered in Malaysia can obtain QMS certification from DQS Malaysia in order to apply establish license from the Authority as follows:

a) For manufacturer, certified to MS ISO/ ISO 13485;

b) For AR, importer and distributor, certificate of conformity to GDPMD


Establishment can obtain following certificate from DQS Malaysia for their medical device to be register with the Authority :

a) For manufacturer, certified according to Full Conformity Assessment

b) For AR, importer and distributor, certified according to Technical Documents Verification or Full Conformity Assessment (in some case)


How does a certification work?

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.


What does certification according to ISO 13485 cost?

The costs of certification according to ISO 13485 depend primarily on the size of your company but also on the complexity of your processes and your organizational structure. We will be happy to provide you with an individual quote.


Why should you have your company certified to ISO 13485 with DQS Malaysia?

  • Recognized expertise in medical devices for more than 20 years
  • Active participation in standards and technical committees
  • Broad product portfolio of various normative and legal certification programs from one source
  • Worldwide network with over 200 experienced assessors and experts

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We would be happy to provide you with a customized quote.