What is the role of Port Health?
To prevent, protect and provide public health response by monitoring the Points of Entry against the health risks associated with cross-border movement of people, conveyances and imported cargo.
Who should import a medical device?
A person may only import a medical device if that person is licensed in terms of section 22C(1)(b) of the Act.
Where must I go if my products are being held at Port Health and are categorised as medical devices?
For any queries related to port health shipment, contact the MD unit MDPorthealth@sahpra.org.za and regulatory compliance unit under key contacts.
The enquirer must attach all the shipping documentation that they have on hand, including the detention notice.
When can I import a used medical device?
Used medical devices or IVDs may be imported by manufacturer for purposes of service, repair, refurbishing or maintenance.
Which licences authorise importation of medical devices?
Manufacturer and Distributor licences medical device establishment licence.
What happens if my consignment/shipment is detained at a Port of Entry?
When SAHPRA detains a consignment, the shipping documents are reviewed and where necessary, the consignment is inspected.
The Medical Devices Unit reviews the shipping documentation against the medical device establishment licence, and the latest product listing, if applicable.
The consignment may be referred to other units within the organization should additional authorization be required.
The Medical Device Unit communicates the recommendation to regulatory compliance unit to assist with the release process.
How do I prevent my consignment/shipment from being detained at a Port of Entry?
To minimise the risk of your consignment being detained at a Port of Entry, please ensure the following:
You hold a valid Medical Device Establishment Licence that authorises the importation of medical devices.
All shipping documentation corresponds with the details reflected on the licence, including:
• The name of the importer;
• The physical address of the licence holder; and
• The risk class category that is aligned with the medical device being imported.
The product list associated with the establishment licence is kept up to date. Where new medical devices are to be imported, the licence holder must submit a notification to update the product list through the prescribed notification process before importation takes place.
What is an expiry date?
The date up to which a medical device or IVD retains the properties which are mentioned on the label, which properties can change after the lapse of time, and after which date the medical device or IVD may not be sold to the public or used. https://www.sahpra.org.za/document/regulations-relating-to-medical-devices-and-in-vitro-diagnostic-medical-devices-ivds/
What is the requirement for expiry dates with regards to medical devices (including IVDs)
Regulation 22 (1)(j) (Labelling of medical device or IVD) indicates that the label of each medical device or IVD must contain the j) the expiry date, where applicable, and (k) where there is no indication of the expiry date, the manufacturing date.
Who should ensure that the medical devices have expiry dates?
It is the manufacturer’s responsibility to ensure that medical devices have expiry dates or batch numbers for traceability purposes. If a medical device has no expiry date or shelf life, that is generally acceptable, provided the manufacturer can scientifically justify that the device does not have a finite expiry date or shelf life that could affect safety or performance.
What are devices that may require expiry dates?
Some of the devices that commonly require expiry dates are:
• Sterile medical devices
• Single-use devices
• Devices containing adhesives
• Devices containing gels or liquids
• Reagents and IVD test kits
• Devices incorporating batteries with limited storage life
• Combination products with medicinal components
Must the expiry date be included on the medical devices or IVDs being imported?
For traceability purposes, the batch number or expiry date, where applicable, should be reflected on the shipping invoice accompanying the imported medical device or IVD.
If the batch number or expiry date is not reflected on the shipping documentation, the port of entry may request justification for its omission. Such cases are subject to review and approval. To support traceability, the importer may be required to provide supporting documentation, such as a batch certificate, calibration certificate, or similar records that enable the identification and tracking of batch numbers, lot numbers, or serial numbers.
This information is essential for facilitating product recalls, investigations, and other post-market surveillance activities.
However, consignments of medical devices will not be detained solely because batch numbers or expiry dates are not reflected in the shipping documentation where such information is not applicable to the product concerned.