| (1) |
A manufacturer, wholesaler or distributor referred to in section 22C(1)(b) of the Act must— |
| (a) |
prior to commencing business— |
| (i) |
apply to the Council for— |
| (aa) |
a manufacturer licence to manufacture, import or export medical devices or IVDs; or |
| (bb) |
a distributor licence to import, export and distribute medical devices or IVDs; or |
| (cc) |
a wholesale licence to act as wholesaler of medical devices or IVDs; |
| (ii) |
appoint and designate an authorised representative who must reside in South Africa— |
| (aa) |
be responsible to the Council for compliance with the Act; and |
| (bb) |
control the manufacturing, distribution, wholesaling and the sale of medical devices or IVDs. |
| (b) |
submit to the Registrar an application for a licence, on a form approved and provided by the Council; |
| (c) |
as part of the application, provide acceptable documentary proof of— |
| (i) |
the particulars of the owner of the business; |
| (ii) |
the particulars of the authorised representative; and |
| (iii) |
certification to a Quality Management System for medical devices and IVDs as determined by the Council; |
| (d) |
specify, as determined by the Council, the medical devices or IVDs or group or family of medical devices or IVDs to be manufactured, imported, exported or distributed and sold; and |
| (e) |
pay the application fee. |
| (2) |
The Registrar may give the person referred to in subregulation (1) written notice to, within a reasonable time as specified in the notice, furnish the Council with such additional documentation or information as the Council may require. |
| (3) |
The Council may, where applicable, inspect the business premises specified in the application. |
(4) If the Council is satisfied that—
| (a) |
the person referred to in subregulation (1) complies with the prescribed requirements; |
| (b) |
the application for a licence— |
| (i) |
to manufacture, import or export medical devices or IVDs; or |
| (ii) |
to act as a distributor; or |
| (iii) |
to act as a wholesaler of medical devices or IVDs complies with the prescribed requirements; and |
the authorised representative is able to provide certified evidence of certification to a Quality Management System as determined by Council, the Council must approve, with or without conditions, the application and issue the person with a licence.
(5) The Registrar must—
| (a) |
keep a separate register for each of the categories of licensees referred to in subregulation (1)(a)(i); and |
| (b) |
enter the licence number, the name of the licensee and his or her physical and postal addresses, in the register. |
| (6) |
Despite the period of validity of the licence, the licensee must pay the annual fee for continued registration as determined by the Council. |
| (7) |
A licensee must notify the Registrar in writing of a change to any of the particulars furnished in the application or entered in the register, which occurs after the issue of the licence. |
| (8) |
An entry into the register which is proved to the satisfaction of the Council, to have been made in error or through misrepresentation or in circumstances not authorised by the Act, may be removed from the register. |
| (9) |
A person in respect of whom an entry has been removed as contemplated in subregulation (8), must be notified of the removal and a certificate issued in respect of the registration in question must be considered to be cancelled as from the date on which notice has been given. |
| (10) |
The Council may, subject to subregulation (11), direct the Registrar to remove the name of a licensee from the register if— |
| (a) |
the licensee does not comply with the Act or the conditions of a licence; |
| (b) |
the authorised representative fails to control the manufacturing or distribution, wholesaling or sale of the medical devices or IVDs; or |
| (c) |
the licensee fails to furnish written reasons within the period stated in the notice referred to in subregulation (11). |
| (11) |
Before directing the Registrar to remove the name of a licensee from the register, the Council must— |
| (a) |
give notice to the licensee of its intention to remove the name of the licensee from the register and to close the licensee's business; and |
| (b) |
invite the licensee to furnish written reasons, within 21 days of the notice, why the licensee's licence must not be removed from the register and the business closed. |
Statistics Act, 1999
