Face masks and NRCS Letter of Authority (LOA)

A number of inquiries have been received on whether an LOA is required to import face masks into South Africa. This is a vital question in light of increased imports of the product.

First, what is an LOA? LOA stands for Letter of Authority and It is a certificate issued by The National Regulator of Compulsory Specifications (NRCS).

An LOA is issued after evaluating the relevant product for compliance with the South African National Standards (SANS). The intention is to ensure products are safe and meet the required minimum standards. There are many products that require LOA’s prior to importing them into South Africa.

Is an NRCS LOA required to import face masks?

This depends on the type of face mask and intended use. There are generally three types of face masks and these are;

General face mask – These are not considered to protect against viruses. They include those made of cloth and textile fabrics.

An LOA is not required for face masks not intended to protect users from viruses and for medical purposes.

Surgical Mask and Medical Respirator Masks – They are regulated under the Medicines Act because they are medical devices. They fall within the ambit of the South African Health Products Regulatory Authority (SAHPRA).

Surgical face masks must comply with the SANS 1866-1:2018. Medical respirator masks must comply with SANS 51049:2003. Surgical masks tested to EN14683 standard currently need to be evaluated and approved by SAHPRA and not NRCS prior to being imported or sold.

N95 and KN95 masks require an LOA prior to being imported or cleared by Customs. They are tested by NRCS according to SANS 50149 and EN14683. Furthermore, these will need to be licensed by SAHPRA for medical or health sector use.

What happens if you import without an LOA?

You may get lucky and get the products cleared by Customs. If not, the shipment will be placed under embargo. This can be costly and disrupt customer orders.

Products placed under embargo are stored in a State Warehouse or in the Importers Warehouse. Releasing of goods to the importer’s warehouse needs a Release Order under embargo from Customs.

The Release Order under embargo comes with specific conditions. No selling and unpacking take place. Customs can conduct a random inspection to check for compliance.

Can a Sales Permit help?

The NRCS may issue a Sales Permit, if the products have already been imported. This does not only apply to face masks but to any other products that require an LOA. A Sales Permit is a means of temporary approval for the products to be sold.

An application must prove compliance with the relevant SANS. Test reports from an ILAC accredited laboratory are vital in this regard.

There are local approved testing companies, in case you do not have valid product test reports. These are conducting certain minimum tests as agreed with NRCS.

A Sales Permit application has fewer requirements than an LOA application. However, it is not a long term solution.

What are the processing times for LOA’s and Sales Permit applications?

The normal processing time is 120 calendar days. However, for COVID-19 products such as masks the NRCS is attempting to fast track.

If you need assistance in applying for an NRCS LOA, Sales Permit, SAHPRA contact us on infor@tradesolutions.co.za.