• Home
  • Industry
  • Notification for Export Only Medical Device

NOTIFICATION FOR EXPORT ONLY MEDICAL DEVICE

NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE

 

            i.  Notification of Export Only Medical Device Form (Annex B)

            ii. APPLICATION FORM NOTIFICATION OF EXPORT ONLY MEDICAL DEVICES (google.com)

  • For submission or any inquiries, please email to exportonly [AT] mda [DOT] gov [DOT] my
  • Officer Incharge:
  • Pn Norlela Hatta - +603 8230 0342
  • En Mohd Shahrezza - +603 8230 0392

 

The flow chart below shows the procedure to obtain Acknowledgement on Notification Letter for Export Only Medical Device:

FLOW CHART

 

Instant Guide to Export Only Medical Device Notification

 

1.   

Who can apply?

Licensed Establishment/Contract Manufacturer/Authorised Exporter

2.   

List of supporting documents:

   a)       Catalogue(s)/ booklet(s)/ leaflet(s)/ copy of labelling that contain information about the intended use, general description, mode of action of the medical device

   b)      A copy of medical device manufacturer/ contract manufacturer QMS ISO 13485

    c)       Letter of authorization from manufacturer/contract manufacturer to exporter (only applicable for authorized exporter)

   d)      Establishment license (if applicable)

   e)       Softcopy of Bank Draft

3.   

Notification Process

a)      Applicant shall submit a notification before exportation of the first shipment

b)     One application shall be made for only one single medical device nomenclature.

4.   

Notification Fee

a)      Each notification shall be submitted together with fee of RM500.00

b)     Notification fee shall be paid through bank draft and payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN"

c)      Payment advice/invoice will only be issued upon request of the applicant.

Remark :

-       Following information must be written at the back of your bank draft

-       CASH WILL NOT BE ACCEPTED.

5.   

Issuance of Acknowledgement on Notification Letter

a)    Upon receipt of completed application and clearance of payment, the authority will issue an Acknowledgement on Notification Letter to the applicant within 14 days after clearance of payment, by letter and email.

b)    This Acknowledgement on Notification letter permits multiple export consignments within the validity period of the Acknowledgement on Notification.

c)     The validity period of the Acknowledgement on Notification for Export Only Medical device is five (5) years

6.   

Conditions on Acknowledgement on Notification

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.

 

 

Updated: 24 March 2022

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 [AT] mda [DOT] gov [DOT] my

Today 2635 Yesterday 7589 Week 33203 Month 15787 Visitor Counter: 113920741

  • Last Modified: 30 November 2022.
facebooktwitterinstagramyoutube
Copyright © 2022 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768