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FORM

Title:Health Technology Assessment (HTA) Application form

Document number:FMQ0022

Version number:3

(Changes from previous version highlighted)

Written by:Mapula Sekano

Checked by:N/A

Approved by:Moodliar, Sarvashni

Active date:21-07-2015

Date of next review / Date reviewed / Reviewed by / Action
21-07-2016

Date withdrawn:……………..

Health Technology Assessment (HTA) application form.
Please return completed form to Quality Assurance Section,
NHLS, 1 Modderfontein Road, Sandringham, 2131

(STRICTLY CONFIDENTIAL)
If you have any questions related to any of the information required in this application form, kindly contact:

Please Note:A pro-forma invoice will be forwarded to the applicant upon receiving the completed application form. A non-refundable application fee of R2500 must be submitted for each In-vitro Diagnostic Device (IVD) application. This fee is subject to change. If this form is not received by the HTA within 30 working days after the date of submission to the supplier, the proposal to evaluate shall be cancelled from the HTA system.

IVD device Technology

Technology Name
Technology description and what is it used for (Indications)?
Type of IVD / Instrument Reagent System comprising both
New Upgrade Research product / Closed System Open System
*New product ID / Product code: / Model: / Version:
*Previous product ID / Product code: / Model: / Version:
*Please include product brochure, package inserts and any applicable evidence document
Include a document that indicates the analytes that the instrument is qualified to perform.
Indicate the analytes you are applying to have evaluated.
Evidence of QMS during production, transport and delivery of IVD product
Please elaborate on the certified technology and provide certificate or assessment report.
Requirements / Manufacturer / Supplier
ISO 9001
ISO 13485
# IVD productRegulatory approval / TGA
(Australia) / Device licence
(Canada) / Shounin
Todokede
(Japan) / FDA
(USA)
ANVISA
(Brazil) / CE
European Union / Other
Recognised
pre-qualified list WHO USAID Other
# Regulatory bodies that are recognised in the NHLS
Has the Technology been used elsewhere in South Africa or the world?
Yes No
If Yes, which organisation/s or health facilities used the technology?
(If more than four add as an annexure)
Provide contact person/s and their contact details for 1.5 above
Name
Address
Email address
Tel/Cell
Has the Technology been evaluated by another organisation / institution?
Yes No
If Yes, provide details of the evaluation outcome in terms of a detailed report and submit as annexture
Is there comparative technology?
Yes No
If YES, please describe whether this Technology is superior in benefits at similar cost
If YES, please describe whether this Technology has similar benefits at lower cost
Please provide a list of the evidence and submit as Annexures (full reports).
Please give an indication of the costs of the Technology (Include Product quote as Annexture)
Outright purchase price
Attach costs for all tests you are interested to evaluate
Attach costs for all consumables
Service / maintenance cost per visit
Frequency Service / maintenance
Anticipated life span of Technology
Infrastructure / environmental specifications required for this technology for Technology (buildings, climate, UPS etc)
Training of personnel
Initial training:
Training of personnel
Subsequent training:
Costs of waste to be generated by the technology
Costs of decommissioning
Describe the safety and occupational health issues that may affect the users of the Technology and / or patients (if applicable)
Describe the environmental issues that may affect the use of the Technology
Is the Technology likely to contribute to a SUSTAINABILITY agenda e.g., less energy use, less waste etc?
Permission granted to NHLS to publish: (If yes , select the relevant )
No / Yes / Conference / NHLS Website
Articles and Journals / Other:
Website - external

Manufacturer information

2.1Name Company
2.2Postal Address
2.3Physical Address
2.4Web Address
2.5Telephone numbers

Supplier Information

Name of Supplier
Contact Name
Contact Telephone No.
Contact E-mail
Postal Address
Physical Address
Web Address
Type of Company (place an ‘X’ alongside as many as applicable)
Manufacturer Service Industry Original Sales Agency Wholesaler
Small Business Local Sales Agency Distributor Regional Sales Agency
Entrepreneur National Sales Agency Other (specify):
Supplier Checklist & Annexures
Completed NHLS form Yes No
Name of person completing form: / Date:
Submitted documents & Annexures (Please list)

Acknowledgement in Processing of this form - For Office Use Only

CE FDA certificate TGA ANVISA ISO 13485 ISO 9001 ISO 9001
(manufacturer) (manufacturer) (Supplier)
Shounin Todokede Canada WHO USAID
Product brochure Applicable Package inserts Product quote
Previous validation records
Processes by: / Date:
Checked by: / Date:
Proof of payment

Acknowledgement of Reading Form

Document number: Version Number:

Title:

My signature confirms that I have read and understood the content of this document and relevant kit insert (where applicable).

Name / Signature / Date

Note to the Quality Rep: - This form must be filed for 5 years to provide audit traceability.

In the event of a dispute concerning this document, the electronic version stored on Q-Pulse will be deemed to be the correct version