Please submit all the information as required. Please note the information as specified in Forms CMM FM 8072- 2 guides you on what must be submitted.
For Sales Permit:
Please complete the application for sales permit fully.The non-compliance is that the KN/N95 masks are not approved as required. Your motivation as to why we need to issue a sales permit for your product. Please submit Test reports (in English) to the standards mentioned, and information for user. All photographic evidence of mask and packaging, we need to see clearly all the markings on both mask and packaging.
For N95/KN95 masks, we will test according to above, SANS 50149 and EN 14683. And will need to be licenced by SAHPRA for medical/health sector use.
We selected the most critical tests for the different products. This is only a temporary agreement with manufacturers and distributors, therefore after this critical period, they must ensure the full testing of their products for approval (homologation).
For local testing only when required:
Protechnik Laboratories a Division of Armscor SOC Ltd
103 Combretum Crescent, Highveld Techno Park, Centurion, Gauteng PO Box 8854, Pretoria, 0001
Tel: +27 12 665 9431 | Fax: +27 12 665 0240 |
E-mail: firstname.lastname@example.org web www.armscordi.com
Approval Manager: NRCS CMM
NB: Kindly note that the type of mask, intention of the masks, the environment in which mask is used and the sterility of the mask determine the regulatory pathway of said mask.
Please see attached for a joint communication to stakeholders (with SABS, NRCS) on regulatory status of gloves, sanitisers and masks.
Medical and surgical masks are classified as Class A medical devices.
Further masks claiming sterility are classified as Class A medical devices with sterility and require the establishment (manufacturer, distributor) to be licensed with SAHPRA under Act 101. In addition compliance to SANS1866 is mandatory.
If the mask is not making claims to protection of viruses or being used by medical personnel, and is specifically for civilian use, which should be specifically labelled aa such, then these fall outside the mandate of SAHPRA.
If medical mask in indicated on the label, the SANS1866 standard must be complied with can be tested by Protechnik for compliance.
For Medical (Surgical) Mask/Respirators SANS 1866:2018 or EN14683 or equivalent.
For Surgical Mask tested to EN14683 or equivalent. Must be sent to SAHPRA not NRCS