NOTIFICATION FOR EXPORT ONLY MEDICAL DEVICE
NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE
The importation, exportation, or placement of a medical device in the Malaysia market requires the medical device to be registered under Medical Device Act 2012 (Act 737). However, The Circular Letter of Medical Device Authority No. 4 Year 2018 Exempts Medical Devices That Are For Export only from registration requirements and only require notification to the Authority has been issued on 3 September 2018.
Submission of Notification
- The applicant for this notification shall be a licensed establishment, contract manufacturer or authorized exporter who is responsible for exporting the medical device.
- The applicant is responsible to confirm that the products are medical devices. Such products which do not meet the medical device definition are not eligible for this requirement.
- Applicant shall submit a notification before exportation of the first shipment, so an “Acknowledgement on Notification” will be issued before exportation of the medical device.
- One notification application shall be made for only one single medical device nomenclature.
- The validity period of the Acknowledgement on Notification for Export Only Medical device is five (5) years.
- Upon receipt of completed application and clearance of payment, the authority will issue the Acknowledgement on Notification Letter to the applicant within 14 days after clearance of payment, by letter and email.
Forms can be downloaded as in table below:
Notification of Export Only Medical Device Form (Annex B)
*Export Only Medical Device Details (Appendix A)
* Export Only Medical Device Details (Appendix A) must be submitted in Word document.
Administrative Charge and Review of the Notification
Each notification shall be submitted together with a RM 500 fee, with the following conditions:
- Notification fee shall be paid through bank draft. CASH WILL NOT BE ACCEPTED. The Authority will not be responsible for the cash sent or brought to MDA.
- Payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN".
- No payment advice/invoice will be issue to the applicant. Therefore please be sure the following information is written at the back of your bank draft as below:
As overall, the notification process can be summarized as in the flow chart below:
Conditions on Acknowledgement on Notification
The Acknowledgement on Notification of medical device for export only shall be subjected to the following conditions. Failure to comply with these conditions will result with its withdrawal.
- The applicant shall ensure that the medical device to be exported within the validity period;
- The applicant shall ensure that the medical device shall not be placed in the Malaysian market unless the medical device is registered under Act 737;
- The applicant shall be responsible for ensuring that the quality, safety and performance of the medical device are not adversely affected during export and storage of the medical device.
Once the Acknowledgement on Notification has expired or has been cancelled/ withdrawn, no further export of the medical device, at any quantity, shall be permitted. Any other conditions may be imposed by the Authority from time to time.
For any inquiries please email to firstname.lastname@example.org
Officer Incharge : En Talha: +603-8230 0383