Important Notes:
1. An application for the cancellation of medical device listing(s) should be made after the medical device is no longer supplied.
2. All fees are not refundable.
3. This form should be duly completed and signed by a Company Director or senior officer of the Registrant.
4. If the space provided in the form is insufficient, please provide the information as an attachment.
5. This form is to be submitted by email or fax to:
Medical Device Branch
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way, #11-03 Helios
Singapore 138667
Email:
Tel: 6866 3560
Fax: 6478 9028
Registrant
Name of company
/Company address
/Contact person’s name
/Job title /
Tel no.
/ /Fax no.
Email Address
/Product Owner
Name of company
/Company address
/Contact person’s name
/Job title /
Tel no.
/ /Fax no.
Email Address
/Please tick one of the following:
“I attest to the possession of records of supply and records of complaints, up to the cancellation date of the medical device listing(s), for the following registered medical device(s).
I am obliged to continue to maintain a record of every complaint received pertaining to the medical device(s) as stipulated in the Health Products (Medical Devices) Regulations.
I am obliged to maintain these records for the period stipulated in the Health Products (Medical Devices) Regulations and provide such records when requested by the Authority.”
I am no longer registered with Accounting and Corporate Regulatory Authority of Singapore (ACRA) as a business entity. I attest that I have transferred records of supply and records of complaints of the following registered medical device(s) to the Product Owner.
No. / Device Name / SMDR Device Registration No.* If there are more SMDR device registrations to be cancelled, please attach a list to this page.
Signature ______
Full Name of Applicant
(as it appears
in the NRIC or Passport) ______
Designation ______
Company Stamp ______
Date ______
(DD/MM/YYYY)
Rev: August 2009 Page 1 of 2