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. The purpose of demonstration for marketing

2. The purpose of education

3. The purpose of clinical research or performance evaluation of medical device

4. A Custom-Made Medical Device; or

5. A 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 form together with supporting documents to Chief Executive, Medical Device Authority (MDA) by email. All notification forms and other related forms can be downloaded from the above link.

Exemption Type	Form Name	Download Form	Submission email
Demo	1. Notification of Medical Device for Demonstration for Marketing	Click Here	[email protected]
Demo	2. Post Handling Notice to MDA : 'Disposed of or Destroyed; or Exported Out of Malaysia’ of Unregistered Medical Device	Click Here	[email protected]
Education	Notification of Medical Device for the Purpose of Education	Click Here	[email protected]
CI	1. Notification to Import and/or Supply Medical Devices for Clinical Investigational Use	Click Here	[email protected]
	2. Notification to Import Medical Devices for Clinical Research Use	Click Here
	3. Serious Adverse Device Events (SADE)	Click Here
	4. Notification for Export /Disposal of Devices Upon Completion /Termination of Clinical Investigation /Drug Study	Click Here
	5. Investigational Device (IDE) Progress Report	Click Here
	6. Notification of Change on Clinical Trial for Medical Devices Use	Click Here
Custom made	Notification of Unregistered Medical Device for Custom Made	Click Here	[email protected]
Special Access	Notification of Unregistered Medical Device for Special Access	Click Here	[email protected]

Detail and further explanation about the forms and other related requirement are describe in guidance document which can be refer here: GD Demonstration , GD Clinical Research .

Payment and Review of the notification

Upon receipt of notification, the authority will issue a payment advice to the applicant. Starting from 28 March 2018 onwards, all notifications shall be accompanied with a fee of RM 300 per notification. All payment shall be made using bank draft payable to “Kumpulan Wang Pihak Berkuasa Peranti Perubatan”. 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 14 working days may be needed upon receipt of notification.

As overall, the notification process can be summarized as in the flow chart below :