Announcement
EXEMPTION FROM REGISTRATION OF MEDICAL DEVICES
The Medical Device (Exemption) Order 2016 which has been gazetted on 18 April 2016 has provided an exemption from registration requirement under Section 5 of Act 737 for medical devices for the purpose purposes:
- Demonstration for marketing
- Education
- Clinical research or performance evaluation of medical device
- Custom-Made Medical Device; or
- Special Access Medical Device
A person who imports or manufactures the above medical device also exempted from the requirement of an establishment license under subsection 15(1) of the Act. However, prior to importation and supplying a device potentially eligible for exemption, manufacturer or importer of the device must submit a notification to Medical Device Authority (MDA). An acknowledgement on the notification issued by the MDA then permits the device to be supplied or imported lawfully for the specific defined use.
Submission of notification
Any local* applicant who wishes to import and/or supply of a medical device shall submit notification together with supporting documents to Chief Executive, Medical Device Authority (MDA). All notification and other related forms can be downloaded either through MeDC@St v2.0 or as in table below.
|
Exemption Type |
Form Name |
Download Form |
Submission email |
|
Demo |
1. Notification of Medical Device for Demonstration for Marketing |
- |
Online via MeDC@St v2.0 |
|
2. Post Handling Notice to MDA : 'Disposed of or Destroyed; or Exported Out of Malaysia’ of Unregistered Medical Device |
- |
||
|
Education |
Notification of Medical Device for the Purpose of Education |
- |
Online via MeDC@St v2.0 |
|
CI |
1. Notification to Import and/or Supply Medical Devices for Clinical Investigational Use |
- |
Online via MeDC@St v2.0 |
|
2. Notification to Import Medical Devices for Clinical Research Use |
- |
||
|
3. Notification of Change on Clinical Trial for Medical Devices Use |
- |
||
|
4. Notification for Export /Disposal of Devices Upon Completion /Termination of Clinical Investigation /Drug Study |
|
||
|
5. Investigational Device (IDE) Progress Report |
|||
|
6. Serious Adverse Device Events (SADE) |
|||
|
Custom made |
Notification of Unregistered Medical Device for Custom Made |
|
|
|
Special Access |
Notification of Unregistered Medical Device for Special Access |
|
*Local : can be either Malaysian citizen or Non-Malaysian, who has an employment pass or residential address in Malaysia (Domiciled in Malaysia).
Administrative Charge and Review of the notification
All new notifications shall be accompanied together with an administrative charge of RM 300 per notification. All payment shall be made using bank draft payable to “Kumpulan Wang Pihak Berkuasa Peranti Perubatan”.
For email submission, no payment advice will be issue to the applicant, therefore please be sure the following information is written at the back of your bank draft.
|
Type of Notification |
Information Needed (written behind the BANK DRAFT) |
|
Custom Made |
1.Custom Made 2.Company Name: 3.Patient Name: |
|
Special Access |
1.Special Access 2.Company Name : Patient Name: |
Once the payment clear, then the Authority will review the information and issue an Acknowledgement on Notification / Letter of No Restriction. A processing time of up to 11 working days may be needed upon payment cleared.
As overall, the notification process can be summarized as in the flow chart below :
Process flow to create MeDC@St account
