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.

*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

Exemption Type	Notification	Fee Amount
Demonstration	New	RM 300
	Subsequent	-
Education	-	RM 300
Clinical Research	New CRU & DS	RM 300
	Subsequent (CRU)	RM 110
Special Access	-	RM 300
Custom Made	-	RM 300

All notifications shall be accompanied together with an administrative charge of RM 300 per notification. All payment shall be made using FPx or bank draft payable to “Kumpulan Wang Pihak Berkuasa Peranti Perubatan”.

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

 

Updated : 15 Feb 2024