Our Services
Medical Device Registration
With the primary objective of protecting public health, many countries mandate that medical devices must be registered with the local authority in accordance with national laws before they can be legally marketed. This process, commonly referred to as premarket approval or clearance, requires the registering company to compile and submit comprehensive, compliant documentation to the technical assessor and regulatory authority, demonstrating the device’s safety, efficacy, and conformity.
It is common for assessors and authorities to challenge the adequacy of submitted documents, raising queries or concerns that must be addressed. The company seeking registration is therefore responsible for providing clear responses and resolving all issues to ensure successful approval of its medical devices.
Essential Requirements for Medical Device Registration
Medical device registration requires two mandatory elements – Quality Management System (QMS) and product dossier. To meet QMS requirements, a valid ISO 13485 certification must be provided to demonstrate that the medical device is manufactured under a controlled quality system with managed risks. The second element is the product dossier, which must be prepared and submitted in accordance with applicable regulatory requirements, covering all mandatory information specified by the relevant authority and providing sufficient evidence of the device’s safety, performance, and clinical effectiveness.
For a clearer understanding of the registration pathway, explore our comprehensive guide on Malaysia’s medical device registration process.
Medical Device Registration in Malaysia
Malaysia has a structured and comprehensive medical device registration framework, outlined in the Medical Device Act 2012 and the Medical Device Regulation 2012. Under this framework, Class A devices are exempt from conformity assessment by a licensed Conformity Assessment Body (CAB). In contrast, Class B, C, and D devices must undergo conformity assessment before the registering company can submit its application to the Medical Device Authority (MDA) for approval.
You deserve a smoother registration process
Correct device classification and grouping
Early engagement with the conformity assessment body
Accurate and complete submissions
Effective communication with both the conformity assessor and the authority
Your Trusted Partner for Medical Device Registration Success in Malaysia
With our proven expertise in medical device registration, we clearly communicate with you on what is required, simplify the process, clear compliance hurdles, and ensure your submission meets every requirement. Partner with us to save time, reduce risk, and achieve approval with confidence.
End-to-End Support
A carefully managed process begins with a thorough understanding of your medical devices and extends through to final approval. Every stage is handled with clarity, precision, and accountability.
Smooth and hassle free process
Early identification of compliance gaps, combined with submission dossier prepared with precision and backed by extensive hands on experience, helps prevent unnecessary delays. This approach minimizes back and forth with conformity assessors and regulatory authorities, avoiding registration complications.
Professional regulatory collaboration
Successful regulatory collaboration is achieved by understanding assessor expectations and responding effectively to feedback, which helps ensure a smoother process.
Proven Expertise Across Multiple Healthcare Disciplines
We has a proven track record of successfully registering and maintaining the registrations of diverse medical products with the authorities.
- Active Medical Devices
- In Vitro Diagnostic Devices
- In Vitro Fertilization Devices
- Infection Control Disposables
- Medical Software
- Nephrology Disposables
- Orthopaedics Implants & Instruments
- Patient-specific Implants
- Surgical Disposables
Beyond Medical Device Registration
Global Rep can act as your independent local authorized representative for medical devices commonly referred to as the registration holder. We take responsibility for maintaining your device registrations, including submitting regulatory change notifications to keep the authority informed of any updates to your devices.
Through our market presence, we support your post market surveillance activities by collecting essential data, collaborating effectively with relevant local entities, and ensuring timely responses to any situation.
Popular Questions
Yes. Any medical device intended to be marketed or distributed in Malaysia must first be registered with the Medical Device Authority (MDA) before it can be legally sold. Registration ensures that devices undergo conformity assessment by a licensed Conformity Assessment Body (CAB) — applicable to Class B, C, and D devices — and evaluation by the MDA. These processes collectively verify the safety, efficacy, and regulatory compliance of the devices.
No. Only a licensed Authorized Representative (AR) appointed by the foreign medical device manufacturer may apply for medical device registration in Malaysia.
The Authorized Representative (AR) serves as the local regulatory liaison for foreign medical device manufacturers. The AR holds the device registration, ensures compliance with the requirements of the Medical Device Authority (MDA), and manages regulatory communications, including conformity assessment, postmarket obligations, and vigilance reporting.
More information: Malaysia authorized representative
The lead time depends on the device classification and the quality of the Common Submission Dossier Template (CSDT). Class A devices typically require 30–50 working days, while Class B, C, and D devices generally take 90–120 working days, subject to the completeness of documentation and the efficiency of the conformity assessment and MDA evaluation processes.
MeDC@St is Malaysia’s official web‑based application system operated by the Medical Device Authority (MDA) for medical device registration and establishment licensing. It is the mandatory platform through which manufacturers, authorized representatives, importers, and distributors submit applications, track approvals, and manage licences. The system also serves as the gateway for local medical device manufacturers and authorized representatives of foreign manufacturers to apply for and manage medical device registrations.
Medical Device Act 2012 (Act 737) mandates that medical devices shall be registered with the MDA before it can be marketed in Malaysia. Marketing unregistered medical devices in Malaysia is a serious offence under the said act. Companies or individuals found guilty face fines up to RM200,000, imprisonment up to 3 years, or both. Devices may also be seized, and establishments risk suspension or revocation of their MDA licence.
More information: Please refer to the official announcement by the MDA for further details on enforcement under Act 737.
A medical device registration in Malaysia is valid for five (5) years from the date of approval by the Medical Device Authority (MDA). To maintain marketing authorization, establishments must apply for renewal before the expiry date. Registration renewal requires repeating the conformity assessment process for Class B, C and D, and submission of updated documentation to confirm continued compliance with safety, quality, and regulatory requirements.