deviceswhichemitradiation.LawsandRegulations:InAugust2007,MalaysiaissuedadraftMedicalDeviceActwhichindicatedanintentiontofollowGlobalHarmonizationTaskForceguidancedocuments.However,theissuanceofimplementingregulationswilldeterminewhetheradherencetotheActwillbeeasyorproblematicformedicaldeviceimporters.Thisreportwillbeupdatedonce...
TÜV SÜD medical device market access The global medical device market is governed by a broad range of national and international regulations and medical equipment certification standards. These regulatory requirements are complex and vary between regions, which can make it...
We are also a full-scope UK Approved Body (0086) assessing medical devices against UK legislation. We review your IVD device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to ...
With offices in Kuala Lumpur, Emergo has the expertise and resources to perform all duties required of your Authorized Representative. Our consultants are up to date on the latest Malaysian medical device regulations and will ensure that you experience a smooth and efficient registration process. ...
The Technical Documentation requirements under the IVDR module are created for building an understanding of regulations and technical documentation.
By following these procedures closely, exporters can ensure safe delivery of their products while also complying with the Malaysian regulations governing exports. This process enables exporters to benefit from the potential offered by Malaysia’s thriving medical device industry without r...
Related Blog Posts Visit ourBlogfor more insight into key trends and regulations from the Asia medical markets, written by our leading consultants and researchers. Medical Device & IVD Pharmaceutical & DMF
Medical device manufacturers and healthcare providers must demonstrate measures for medical device cybersecurity and ongoing compliance with regulations.
ASEAN Medical Device and Pharmaceutical Regulations August 12, 2018 Regulation Malaysia Drug Market Update 2017 June 26, 2017 Publication Related News Briefs Visit our Resource Center to view free webcasts and charts or read publications, news, and research reports on the Asia...
related to all types of medical devices, and participate in key standards committees. TÜV SÜD Product Service is also a member of Team NB, the European Association for Medical Devices of Notified Bodies, which facilitates the exchange of information on medical device standards and re...