South Africa's SAHPRA Guideline for Borderline Products: Determining the Regulatory Pathway

The South African Health Products Regulatory Authority (SAHPRA) has issued the Guideline for Borderline Products to help determine the appropriate regulatory pathway for products where classification is unclear. The guideline addresses products that may fall within categories such as medicines, medical devices, cosmetics, disinfectants, foodstuffs or other consumer products. Classification is determined on a case-by-case basis.

What Are Borderline Products?

Borderline products are products where it is not immediately clear which regulatory legislation applies. A product may have characteristics of more than one category, creating overlapping or conflicting regulatory requirements. The guideline provides a structured approach for determining the appropriate regulatory category and covers products regulated under the applicable South African legislation.

How SAHPRA Determines Classification

SAHPRA considers the legal definition of the product, its primary intended purpose and use, and the explicit or implicit claims made for it.

Other factors include the product's composition, primary mode of action and intrinsic properties. SAHPRA may also consider similar products and classifications in other jurisdictions, although these are not binding on the Authority.

Primary Mode of Action

The primary mode of action is an important factor when distinguishing between medicines and medical devices. SAHPRA considers whether the main intended effect is achieved through pharmacological, immunological or metabolic means.

For example, a metered-dose inhaler containing a scheduled substance for asthma has a pharmacological primary mode of action and is regulated as a medicine. A drug-eluting stent, however, primarily functions by keeping a blood vessel open, while the medicinal substance has a secondary role, supporting classification as a medical device.

Medicines, Medical Devices and Combination Products

Medicines may be classified according to their intended use or claims relating to the diagnosis, treatment, mitigation, modification or prevention of disease, or the modification of bodily functions.

Medical devices may be intended for purposes including diagnosis, prevention, monitoring or treatment of disease and other specified medical purposes. Their primary intended action must not be achieved through pharmacological, immunological or metabolic means.

For combination products, the component providing the primary intended mode of action is important in determining classification.

Food, Cosmetics and Consumer Products

Products presented as foods or supplements should not make therapeutic claims, as such claims can result in classification as a medicine.

The guideline also addresses products that fall outside the main regulated categories, including certain exercise equipment, software applications and information and communication technology products. Where a product has a medical-device function, it may instead be subject to medical device requirements.

Requesting Classification of a Borderline Product

The classification process may be initiated by a prospective applicant before submitting an application for registration. SAHPRA may also initiate the process after reviewing a product registration application.

Recommendations are made through a Technical Advisory Committee (TAC) appointed by SAHPRA. The committee includes relevant SAHPRA representatives and external experts where appropriate.

SAHPRA provides the applicant with a decision on the regulatory classification. Where the product falls outside SAHPRA's jurisdiction, the applicant may be directed to an appropriate alternative authority.

Application and Supporting Information

Applicants must submit the required classification information and supporting documentation. This may include a cover letter, table of contents, labelling, information for use, marketing material, safety data, developmental information and the proposed classification with supporting rationale.

The rationale should address the product's composition, mode of action, evidence and proposed claims.

Classification May Change

A classification decision may change when new information or evidence becomes available. Changes to legislation, scientific knowledge, packaging, promotion, presentation, claims or composition may affect the classification. Applicants should therefore inform SAHPRA of relevant changes to the product and should not assume that a classification will remain unchanged throughout development.

For manufacturers and applicants, early assessment of the intended purpose, claims, composition and primary mode of action can help determine the appropriate regulatory pathway.

References

• SAHPRA: Guideline for Borderline Products, SAHPGL-CRO-01, Version 1, dated 26 August 2026.