DEPARTMENT OF HEALTH

**APPLICATION FOR A LICENCE TO IMPORT OR MANUFACTURE\
A LISTED ELECTROMEDICAL PRODUCT**

SECTION 4(1)(b), HAZARDOUS SUBSTANCES ACT, 1973 (ACT 15 OF 1973)

**Postal Address: Director: Radiation Control, Private Bag X62,
Bellville, 7535**

## Street Address: 2nd Floor, Louwville Place, cor. Vrede & Kort St., Bellville, 7530

**Enquiries: Tel: 021 - 948 6162 Fax: 021 - 946 1589**

A: APPLICANT

  ----------------- ----------------- -------------- --------------------------
  **Name:**                                          

  **Postal                            **Street       
  Address:**                          Address:**     

                                                     

                                                     

                                                     

                    **Postcode:**     **Website:**   
  ----------------- ----------------- -------------- --------------------------

B: CONTACT PERSON

  ----------------------- ----------- ------------- ---------- ----------------
  **Name:**                                                    **Title:**

  **Designation:**                    **E-mail:**              

  **Tel:**                **Cell:**                 **Fax:**   
  ----------------------- ----------- ------------- ---------- ----------------

C: PRODUCT INFORMATION

  -----------------------------------------------------------------------
  **Sell *or* Clinical Trials *or* Other ........................**
  *(specify)*

  **Brand:**

  **Model:**

  **Intended use of this product?**

  **Manufacturer Name:**

  **Manufacturer Address:**

  **Manufacturer Website:**
  -----------------------------------------------------------------------

D: DECLARATION

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  **I,                                                                                                                                             
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  hereby declare the information supplied to be correct and true to the best of my knowledge.**                                                    

  **Designation:**                                                                                                                                 

  **Signature:**                                                                                                                                   **Date:**
  ------------------------------------------------------------------------------------------------------------------------------------------------ -----------------------------------

**REQUIREMENTS**

**re**

**APPLICATION FOR A LICENCE TO IMPORT OR MANUFACTURE\
A LISTED ELECTROMEDICAL PRODUCT**

[The applicant must supply the following documentation for **each**
model to be imported or manufactured, marking the annexures as indicated
and checking all the applicable boxes on this page:]{.underline}

Annexure **A**: Completed application form 41BM-1; ***and***

Annexure **B**: Colour brochure (including technical specifications);
***and***

Annexure **C**: Letter of appointment as authorised representative from
original manufacturer; ***and***

Annexure **D**: (i) EC Declaration of Conformity by the original
manufacturer; ***and***

> \(ii\) Notified Body certificate(s) in terms of EC Directive 93/42/EEC
> or 90/385/EEC (whichever is applicable);
>
> ***or***

Annexure **D**: FDA Certificate to Foreign Government

**Clinical Trials:**

If a listed electromedical product is to be imported into or
manufactured in South Africa solely for the purpose of conducting
clinical trials with it, [the applicant must supply the documentation
indicated in Annexures A to C (above), as well as the following
documentation:]{.underline}

##  Annexure 1: Copy of the approved Research Protocol for the clinical trials; *and*

##  Annexure 2: List of the medical institutions where the clinical trials will be conducted; *and*

##  Annexure 3: List of the physicians who will supervise the clinical trials; *and*

Annexure 4: Copy of the letter(s) in which the Medical Ethics/Research
Committee(s) gives approval for the clinical trials to be performed at a
particular medical institution.

[N.B.]{.underline} If, following completion of the clinical trials, the
product is to be offered for sale in South Africa, the documentation in
Annexure D must be submitted at that stage.