MEDTECH

CONSULTING

BY UNIVERSAL THERAPEUTICS

MedTech Consulting is a professional consultancy firm for medical devices, specialising in In Vitro Diagnostics (IVDs). With in-depth industry knowledge, we offer expert guidance throughout the registration process with the Medical Device Authority (MDA).

Additionally, we excel in preparing documentations for Good Distribution Practice for Medical Devices (GDPMD) and ISO13485:2016 Quality Management Systems (QMS), ensuring full compliance with these essential standards. We take pride in delivering exceptional customer service and prompt results, driven by our team of experienced consultants dedicated to our clients' success.

OUR ACCREDITATIONS

Good Distribution Practice for Medical Devices (GDPMD)

Medical Device Authority (MDA) Establishment License

ISO 13485:2016 QMS

HOW WE CAN HELP

IVD Registration Consultancy Support

- Grouping and classification of devices

- Product dossier preparation

- Appointment of Conformity Assessment Body (CAB) for Product Verification or Full Conformity Assessment

- Assist with MeDC@St 2.0 medical device registration application

Authorised Representative

- Appointment of Authorised Representative for foreign manufacturers

- Facilitation of import and distribution activities in Malaysia

Establishment License

- Preparation of documentation for establishment license application, including for Authorised Representative, Importer, Distributor and Manufacturer's establishment licenses

- Assist with MeDC@St 2.0 establishment registration application

GDPMD

- Development of processes and documentation for GDPMD certification

- Arrangement of external audit and certification by Conformity Assessment Body (CAB)

ISO 13485:2016 QMS

- Development of processes and documentation for ISO 13485:2016 certification

- Arrangement of external audit and certification by Conformity Assessment Body (CAB)

NEWS AND UPDATES

NEWS AND UPDATES

Featured
APRIL 2024 REGULATORY OVERVIEW
Read More →
MARCH 2024 REGULATORY OVERVIEW
Read More →
FEBRUARY 2024 REGULATORY OVERVIEW
Read More →

WHAT OUR CLIENTS SAY

  • "The team at Medtech Consulting provided valuable insights, walked us through the entire registration process, and ensured that we were compliant every step of the way. Their expertise is unmatched, and we highly recommend their services."

    Director of Regulatory Affairs,
    A Malaysian Based Biotech Company

  • "Responsive, reliable, and experts in their field. Very satisfied."

    Director of Operations,
    A Singapore Based Medical Devices Manufacturer

  • "I couldn't have navigated the complex process of registering our medical device in Malaysia without the expert guidance of the team at Medtech Consulting. Highly recommend their services!"

    Regulatory Affairs Specialist,
    A China Based Medical Devices Manufacturer

  • "As a medical professional, I had limited knowledge of the regulatory requirements for medical devices in Malaysia. Medtech Consulting is a crucial asset in our market entry. Thanks to their support, our device is now making a positive impact in the Malaysian healthcare sector."

    Chief Executive Officer (CEO),
    A Malaysian Based Medical Company

  • "Invaluable assistance for entering the Malaysian market. Top-notch service."

    Director of Quality Assurance,
    An Indian Based Medical Device Design and Manufacturing Plant

LET’S WORK TOGETHER

Request more information from our regulatory specialists.