Establishment License Information
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 :
B. Related Guideline :
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)
J. Frequently Ask Questions (FAQs) - Under Revision
K. For any inquiries, kindly contact us for further assistance:
- Licensing Unit email address:
General email: license-[email protected]
L. Licensing Unit telephone number:
- Syahmi bin Sapit : +603 8230 0351
- Dinesh Murgis : +603 8230 0393
- En. Muhammad Fadzli bin Rusli : +603 8230 0246
- Suhaida binti Rasul : +603 8230 0214
- Aidahwaty Ariffin @ Aidahwaty M.Olaybal, A.M.N. (BKPP Director): Office Number: +603 8230 0341 or Handphone Number: +6016 333 7031
For assistance related to [email protected]+ system technical issues, kindly submit ticket via [email protected]+
M. Information on Fee Structure
Importance Notice:
Licensing Unit,
Pre-Market Control Division, MDA
Information is updated on 25th March 2024