YOU ARE NOT ALONE.
GUIDING YOU THROUGH
COMPLIANCE OBSTACLES
With in-depth industry knowledge, we offer expert guidance throughout the medical device registration process with the Medical Device Authority (MDA). Our primary goal for the consulting arm is to assist manufacturers and distributors in complying with Malaysia’s regulatory requirements.
In addition, we offer our expertise in preparing documentations for ISO13485:2016 Quality Management Systems (QMS) and Good Distribution Practice for Medical Devices (GDPMD). We understand the importance of adhering to these standards and can help ensure that your company is fully compliant with them.
IVD Registration Consultancy Support
Our Expert Consultants service specialize in guiding you through the entire registration process, ensuring compliance with the stringent requirements set forth by regulatory authorities. From compiling and preparing the necessary documentation to facilitating communication with regulatory agencies, our goal is to streamline the registration process and expedite market access for your IVD products. We ensure that your submissions are accurate, complete, and meet all regulatory standards.
Authorised Representative
Our Authorised Representative service offer a trusted partnership to foreign IVDs manufacturers who wish to market their products in the Malaysian market . We handle the necessary regulatory documentation, communications, and compliance-related responsibilities on behalf of the manufacturer. This includes liaising with regulatory agencies, responding to inquiries, and assisting with product registrations or approvals.
Establishment License
Our Establishment License service is designed to streamline the often complex and time-consuming task of securing the required licenses. We work closely with our clients to understand their specific needs and supports the application process. This includes setting up your MeDC@St 2.0 portal, preparing and submitting all necessary documentation, coordinating with regulatory authorities, and ensuring that all legal requirements are met.
Good Distribution Practice for Medical Device (GDPMD)
Our GDPMD service specialize in providing comprehensive support for achieving GDPMD certification in Malaysia. We actively assist in the development of processes and documentation that align with GDPMD standards. Our expert team works closely with your organization to assess your current distribution practices, identify areas of improvement, as well as arranging for reputable Conformity Assessment Bodies (CAB) to conduct audits and issue GDPMD certification.
ISO 13485:2016 QMS
Our ISO 13485 Quality Management Systems (QMS) consultancy service provides valuable support to organisations seeking to obtain ISO 13485 certification to become medical device manufacturers. Our experienced consultants work closely with your team to develop and implement robust QMS that align with the ISO 13485:2016 standard. We will guide you through the entire certification process, from initial gap analysis and documentation development to staff training and internal audits.