As a leading medical device consultant in Malaysia, we provide comprehensive Authorized Representative services to ensure your medical devices comply with all regulatory requirements set by the Malaysian Medical Device Authority (MDA). Our expertise in GDPMD and ISO 13485 standards ensures seamless market entry and ongoing compliance for foreign manufacturers.
Why Choose Us as your Authorised Representative?
Regulatory Expertise –
We have extensive experience navigating the Malaysian medical device regulatory landscape.
Our team is well-versed in the Medical Device Act 2012 and Medical Device Regulations 2012.
Compliance with GDPMD and ISO 13485 standards is at the core of our services.
Comprehensive Services –
Product Registration: We manage the entire registration process, ensuring your medical devices meet all regulatory standards.
Post-Market Surveillance: We monitor your products post-market to ensure continuous compliance and safety.
Liaison with Authorities: We act as your primary point of contact with the MDA and other relevant authorities.
Quality Assurance –
Our robust Quality Management System (QMS) is certified under Good Distribution Practice for Medical Devices (GDPMD).
Our commitment to quality, including adherence to ISO 13485 standards, ensures your products are handled with the highest standards of care.
Our Service Include
Product Registration
We manage the submission of registration applications and ensure timely approvals.
Compliance Monitoring
We keep you informed of any regulatory changes and ensure your products remain compliant with GDPMD and ISO 13485 standards.
Labeling and Documentation
We ensure that your medical devices are correctly labeled and all necessary documentation is in place.
Market Access Support
We assist in authorizing importers and distributors, facilitating smooth market entry.
Partner with us, the trusted medical device consultant in Malaysia, to ensure your medical devices meet all regulatory requirements. Contact us today to learn more about our Authorized Representative services and how we can support your business.
Services
Related Industries
Medical Device Registration
Register your medical device and expand your markets! We provide service for medical device registration in Malaysia and worldwide.
The medical device manufacturers and distributors are required to apply for their establishment license to carry out their all type of device activities.
ISO 9001:2015 sets out the criteria for a quality management system that can be implemented by any organization of any sizes, of any industry and field.
