• Home
  • Industry
  • Exemption
  • Announcement

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:

  1. Demonstration for marketing
  2. Education
  3. Clinical research or performance evaluation of medical device
  4. Custom-Made Medical Device; or
  5. 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

 Click Here

ci@mda.gov.my

5.     Investigational Device (IDE) Progress Report

 Click Here

6.     Serious Adverse Device Events (SADE)

 Click Here

Custom made

Notification of Unregistered Medical Device for Custom Made                               

 Click Here

sa.cm@mda.gov.my

Special Access

Notification of Unregistered Medical Device for Special Access                    

 Click Here

sa.cm@mda.gov.my

*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 :

Administrative Charge and Review of the notification flowchart

Process flow to create MeDC@St account 

 

Flowchart Notification Akaun

 

 

 

 

 

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my