Welcome to KAYV CONSULTING SERVICES : Your one stop ISO Certification Consultant in Malaysia.

KAYV CONSULTING SERVICES

From START to FINISH, We ensure a Satisfied Result.

MALAYSIA MEDICAL DEVICE REGULATORY SUPPORT

Medical Device Registration in Malaysia

Planning to place a medical device on the Malaysian market? We help manufacturers, importers and distributors navigate the Medical Device Authority (MDA) registration process with clear, end-to-end regulatory support.

From initial regulatory assessment to successful submission, KAYV Consulting supports you throughout the registration process.

Device Classification

Regulatory assessment and classification guidance.

Conformity Assessment

CAB coordination for Class B – D devices.

Technical Documentation

CSDT and supporting documentation preparation.

Gap Analysis

Identify documentation and compliance gaps early.

MeDC@St Submission

Application preparation and submission support.

MDA Query Support

Support for queries and additional information.

Medical Device Registration and Regulatory Consulting

Special Promotional Package

Complete Regulatory Support

RM12,000

Complete regulatory support for your company + 1 Medical Device.

GDPMD Consultation & Documentation
GDPMD Audit Preparation
Establishment Licence Application Support
1 Medical Device Registration
CSDT Preparation & Technical Documentation Review
MDA Submission Support
Regulatory Guidance Throughout the Process

One Package. From Company Setup to Product Registration.

Get your company and medical device ready for Malaysian regulatory compliance with professional guidance throughout the process.

Not Sure Where to Start?

We can help you determine the right regulatory pathway for your medical device and company.

Is my product a Medical Device?
What is the classification of my device?
Does my company need GDPMD?
Which Establishment Licence do I need?
What documents are required for registration?
Does my medical device require MDA registration?

KAYV CONSULTING

Medical Device Regulatory & Compliance Services

From initial regulatory assessment to GDPMD, Establishment Licensing, CSDT preparation and Medical Device Registration — we guide you through every stage of the process.

Have a medical device you want to bring into Malaysia?

Terms and conditions apply. Package eligibility is subject to product and company assessment. Government, CAB, certification, testing and other third-party fees are excluded unless specifically stated in the quotation.