Introduction:

In accordance with Section 15 (1) of the Medical Device Act (Act 737), no establishment shall import, export, or place in the market any registered medical device unless it holds an establishment license granted under this Act.

Definition of Establishment :

  • A person who is either a manufacturer, importer, or distributor who is responsible for placing any medical device in the market but does not include retailer; and
  • An authorized representative (AR) appointed by a manufacturer having a principal place of business outside Malaysia

   A. Related Guidance Document :

    1. Licensing for Establishment
    2. Good Distribution Practice for Medical Devices (GDPMD)

    3. Change of Ownership For Medical Device Registration

    B. Related Guideline : 

    1. How to Apply for Establishment Licence Under Medical Device Act 2012 (Act 737)

    C. How to create MeDC@St account

    D. Overview of Establishment Licensing Framework

    E. Overview of Establishment License Application

    F. Explanatory on amendment major and minor

    G. Requirement on Good Distribution Practice of Medical Device (GDPMD)

    H. List of Registered CAB 

     I. License Statistic

     J. Frequently Ask Questions (FAQs) 

     K. For any inquiries, kindly contact us for further assistance:

    • Licensing Unit email address:

       General email: license-unit@mda.gov.my

      L. Licensing Unit telephone number:

    1. Syahmi bin Sapit : +603 8230 0351
    2. Dinesh Murgis : +603 8230 0393
    3. En. Muhammad Fadzli bin Rusli : +603 8230 0246
    4. Suhaida binti Rasul : +603 8230 0214
    5. Puan Aidahwaty Ariffin @ Aidahwaty M.Olaybal, A.M.N. (BKPP Director): +603 8230 0341 or HP Number (Whatsapp only) : +6016 333 7031

For assistance related to MeDC@St2.0+ system technical issues, kindly submit ticket via MeDC@St2.0+

      M. Information on Fee Structure

      N. 

 Importance Notice:

1. ANNOUNCEMENT: FASTER APPROVAL FOR ESTABLISHMENT LICENSE APPLICATION – COMPLETE APPLICATIONS PROCESSED WITHIN 14-21 WORKING DAYS.

2. PELAKSANAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN MULAI 1 JULAI 2024

3. PENGUMUMAN PELAKSANAAN PENGGUNAAN SIJIL LESEN ESTABLISMEN ELEKTRONIK BERMULA 5 JUN 2024

 

Licensing Unit,
Pre-Market Control Division, MDA
Information is updated on 25th March 2024