South Africa - Apply Licence to Use Medical Laser

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Procedure

Apply In-Person:

1. To apply for license to a Medical Laser in person, the applicant has to visit the office of South African Health Products Regulatory Authority.
2. For contact details, refer “Radiation Control” in the following link: Link
3. Visit the office and obtain an Application for a Licence to Use, Operate, Apply, Install or Keep Installed a Medical Laser (SBLM-1 form) from the concerned department. Or click to download: Link
4. Enquire the officials at the office about the documents to be attached with the completed application form. Complete the application form as required with relevant information and details.
5. After completing the application form with respect to the need, attach the required documents with the completed form.
6. Then, submit it to the respective authority at the office of South African Health Products Regulatory Authority.
7. Also pay the prompted fees as required. After that, your application form and documents attached will be forwarded further for various processes of verification and validation.
8. Once all the processes are done and documents are found in order, your application will be approved and license will be issued with prior notification.

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Required Documents

• Completed application form
• Proof of registration for Laser Safety Officer
• Document for Qualification
• Certificate of Experience in Laser Radiation Protection
• Product license document/card
• Purchase bill or invoice
• Proof of payment
• Detailed description on usage
• Approval from Medical Ethics Committee
• Any supporting document (as instructed)

Office Locations & Contacts

SA Health Products Regulatory Authority (SAHPRA) Head Office
Physical Adsress:Building A
Loftus Park
402 Kirkness Street
Arcadia
Pretoria
0001
South Africa
Postal Adsress:PPrivate Bag X828
Pretoria
0001
South Africa
Tel: 012 395 8000
Email: [email protected]
Website link

Department of Health South Africa Head Office
Physical Adsress:Dr AB Xuma Building, 1112 Voortrekker Rd,
Pretoria Townlands 351-JR,
PRETORIA, 0187
South Africa
Postal Adsress:Private Bag X828,
PRETORIA,
0001
South Africa
Tel: 012 395 8000
Email: [email protected]
Website link

Eligibility

• Any individual or organisation, that wants to use, operate, apply, install or keep an installed medical laser, is eligible to apply.
• To become eligible for obtaining a license, the individual or organisation must appoint a Laser Safety Officer with respect to the Medical Laser and get him/her officially registered.

Fees

You can obtain any details regarding the fees from the office that you visit to apply.

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Application for a Licence to Use, Operate, Apply, Install or Keep Installed a Medical Laser (SBLM-1 form): Link

Sample Documents

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Processing Time

Please explain processing time taken in obtaining the document/certificate.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

Applicants are advised to be aware of the codes of practice formulated by the SAHPRA in accordance with the usage of the Medical Laser, which can be obtained from the office itself.

Required Information

• Particulars of applying entity
• Name of the Laser Safety Officer
• Address details
• Qualifications and experience details
• Street address
• Product details
• Product Sales Licence Number
• Information regarding Safety Control Measures
• Usage description
• Validity period of MEC approval
• Signatory’s designation

Need for the Document

Any person, health facility or organisation in the Republic of South Africa, that wants to operate, apply, install or keep an installed medical laser, in its possession, must apply in prescribed format and get licensed by the South African Health Products Regulatory Authority.

Information which might help

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Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Link
Link

Others

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