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What is Malaysia medical device registration
Administered by the Medical Device Authority (MDA) and passed in 2012, the Medical Device Act 2012 replaced the country’s voluntary product registration scheme, originally established in 2006, and now require registration of all medical devices manufactured, imported into or distributed in Malaysia.
To register a medical device for sale in Malaysia, a manufacturer must retain the services of a conformity assessment body (CAB) licensed by the Medical Device Authority (MDA) to review and certify the registration application. TÜV SÜD is a licensed CAB. As part of the conformity assessment process, the CAB will conduct a technical file review and an audit of the manufacturer’s quality management system. Certified applications are then submitted to the Medical Device Authority (MDA) through an online registration system for final review and approval.
In addition to these requirements, manufacturers and importers must obtain an establishment license to legally market or sell medical devices in Malaysia. Manufacturers with no local presence in Malaysia are also required to appoint a Malaysia Authorised Representative, responsible for managing the medical device registration in Malaysia and serving as the manufacturer’s legal representative in all dealings related to the review and approval of the device.
To register a medical device for sale in Malaysia, a manufacturer must retain the services of a conformity assessment body (CAB) licensed by the Medical Device Authority (MDA) to review and certify the registration application. TÜV SÜD is a licensed CAB. As part of the conformity assessment process, the CAB will conduct a technical file review and an audit of the manufacturer’s quality management system. Certified applications are then submitted to the Medical Device Authority (MDA) through an online registration system for final review and approval.
In addition to these requirements, manufacturers and importers must obtain an establishment license to legally market or sell medical devices in Malaysia. Manufacturers with no local presence in Malaysia are also required to appoint a Malaysia Authorised Representative, responsible for managing the medical device registration in Malaysia and serving as the manufacturer’s legal representative in all dealings related to the review and approval of the device.
How TÜV SÜD can help you with Malaysia medical device registration
TÜV SÜD Malaysia is a licensed CAB under Malaysia’s MDA, authorised to evaluate and certify applications for medical device registration in Malaysia.
We offer technical file review by Full Conformity Assessment or Conformity Assessment by Product Verification, and we are qualified to conduct audits of a manufacturer’s quality management systems, as required by the provisions of the MDA which include Good Distribution Practice of Medical Device (GDPMD) and ISO 13485.
Besides, our ISO 17025 and GLP certified laboratories provide biocompatibility studies, product safety and reliability testing for medical devices according to relevant standards. We also conduct factory audits to test compliance with international standards for other quality management systems, including ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 27001, IATF 16969, ESD 20.20, and others.
We are a trusted service provider for companies ranging from global manufacturers to regional and local firms. Our extensive international network makes us an effective partner for manufacturers seeking global market access for their products. A Regulatory Foreign Affairs and Clinical Centre of Excellence adds to our expertise.
Our technical professionals are actively involved in standards development activities related to medical devices and participate in several key standards committees. TÜV SÜD is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognized Notified Body, while our testing services are conducted through TÜV SÜD Testing Labs.
We offer technical file review by Full Conformity Assessment or Conformity Assessment by Product Verification, and we are qualified to conduct audits of a manufacturer’s quality management systems, as required by the provisions of the MDA which include Good Distribution Practice of Medical Device (GDPMD) and ISO 13485.
Besides, our ISO 17025 and GLP certified laboratories provide biocompatibility studies, product safety and reliability testing for medical devices according to relevant standards. We also conduct factory audits to test compliance with international standards for other quality management systems, including ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 27001, IATF 16969, ESD 20.20, and others.
We are a trusted service provider for companies ranging from global manufacturers to regional and local firms. Our extensive international network makes us an effective partner for manufacturers seeking global market access for their products. A Regulatory Foreign Affairs and Clinical Centre of Excellence adds to our expertise.
Our technical professionals are actively involved in standards development activities related to medical devices and participate in several key standards committees. TÜV SÜD is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on standards and regulations applicable to medical devices.
TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognized Notified Body, while our testing services are conducted through TÜV SÜD Testing Labs.
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