NOTIFICATION FOR EXPORT ONLY MEDICAL DEVICE

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Once the Acknowledgement on Notification has expired or has been cancelled/ withdrawn, no further export of the medical device, at any quantity, shall be permitted.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.