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Medical Device Registration in Malaysia
TECOLAB guide you through every step of registering your medical device in Malaysia
Are you looking to register your medical device in Malaysia? We provide professional support to ensure your product complies with the Medical Device Act 2012 (Act 737) and meets the requirements of the Medical Device Authority (MDA). Explore the registration steps below.
Step 1: ISO 13485 / GDPMD Certification
ISO 13485 certification applies to manufacturers, ensuring a robust quality management system that covers all stages of design, production, and distribution.
GDPMD certification is mandatory for authorized representatives, importers, and distributors to guarantee the quality, safety, and performance of medical devices throughout the supply chain.
TECOLAB reviews your processes, identifies compliance gaps, and provides guidance to achieve ISO 13485 implementation and GDPMD readiness in line with MDA requirements.
Step 2: Establishment License Application
Establishment License is a mandatory requirement by law, for the placement of medical devices in the Malaysian market. There are four types of Establishment License namely:
- License for Manufacturer
- License for Authorized Representative
- License for Importer
- License for Distributor
TECOLAB helps identify the correct licence type, prepares and reviews application documents, and ensures a smooth submission to the MDA.
Step 3: Medical Device Classification, Grouping & Technical Documentation Preparation
Medical devices are classified by risk:
- Class A – Low
- Class B – Low-moderate
- Class C – Moderate-high
- Class D – High
Apart from classification, medical devices are also generally grouped into the following categories:
- Single
- Family
- System
- Set
TECOLAB identifies the correct classification and grouping, prepares technical documentation (EPSP, CSDT, PMS, CER, Risk Management File, IFU) and ensures all records meet Malaysian regulatory standards for submission.
Click here to learn more about the technical documentation.
Step 4: Conformity Assessment with a Conformity Assessment Body (CAB)
Class A devices follow a self-declaration route and do not require CAB assessment. Class B, C, and D devices are subject to conformity assessment to demonstrate compliance with applicable safety and performance requirements.
For Class B, C, and D devices, there are two types of CAB assessment:
- Full Conformity Assessment – for devices approved in non-recognized countries by MDA
- Conformity Assessment by Way of Verification – for devices approved in recognized countries by MDA (European Union, United States of America, Canada, Japan, and Australia)
The following conformity assessment elements are evaluated by the CAB:
- Quality management system (QMS)
- A system for post-market surveillance
- Technical documentation
- A declaration of conformity
TECOLAB coordinates with the selected CAB, prepares and submits technical documentation, and assists in responding to queries or corrective actions. For Class A devices, we guide clients through self-declaration requirements.
Step 5: Medical Device Registration Application
This is the final step to legally market a medical device in Malaysia. The submission includes all required technical documentation, conformity assessment results, and supporting information for MDA approval.
TECOLAB prepares and reviews medical device registration applications, ensures all supporting documentation is complete, and manages submissions and communications with the MDA through the MeDC@St system until approval is granted.