The article describes in detail the regulatory requirements related to the procedure of medical device establishment license renewal in South Africa based on the respective documents.
The South African Health Products Regulatory Authority (SAHPRA), the country’s regulating authority in the sphere of medical devices, has published guidance documents dedicated to the process of establishment license renewal. The documents are intended to assist license holders in interpreting the applicable regulatory requirements and ensuring compliance thereto. The recommendations communicated by the authority by the virtue of the present guidance documents are based on the Medicines and Related Substances Act, the scope of which covers medical devices as well. According to the said Act, the Authority may, on the application in the prescribed manner and on payment of the prescribed fee, issue to a medical device establishment, manufacturer, wholesaler or distributor of medicine, Scheduled substance, medical device a license to manufacture, import, export, act as a wholesaler of or distribute, as the case may be, such medicine, Scheduled substance, medical device or IVD upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the Authority may determine. As prescribed by the applicable regulations, medical device manufacturers and distributors are obliged to hold a valid establishment license to be allowed to undertake their activities.
Regulatory Requirements: Key Points
As it was mentioned before, the entities operating in the sphere of medical devices are obliged to apply for and hold establishment licenses covering the respective types of activities. To meet the eligibility criteria, the applicant entity should demonstrate compliance with the applicable regulatory requirements including, inter alia, the development, and implementation of a quality management system compliant with the requirements set forth by the international standard ISO 13485. The aforementioned standard outlines the requirements to be fulfilled by the entities involved in operations with medical devices at any stage of the product life cycle (e.g., initial design and development, manufacturing process, storage, distribution, maintenance, repair, etc.). The authority also mentions that the requirements prescribed by this standard could be followed by other parties involved in operations with medical devices or any of the components thereto.
Apart from the general overview of the regulatory requirements in the sphere of activities related to medical devices, the document also provides clarifications regarding certain specific aspects associated with the particular way these requirements should be interpreted and followed. In particular, the authority states that due to the delay in the accreditation of South African Conformity Assessment Bodies, the requirement to provide an ISO13485 certificate upon application for renewal of a medical device establishment license is extended for three (3) years from the date of signing of the document and or until further communication is shared by SAHPRA. However, the entities undertaking activities with medical devices are responsible for the development and implementation of the quality management system, while the authority reserves the right to revoke or suspend the establishment licenses in case of issues or non-compliances identified.
Establishment License Renewal Process in Brief
The second guidance document published by the SAHPRA describes in detail the process of renewal of a medical device establishment license. The recommendations provided therein are based on provisions of the Medicines and Related Substances Act 1965, and also of Regulation 5 of the General Regulations on Medical Devices. According to the said regulations, a manufacturer, distributor (including importer and/or exporter) or wholesales referred to in Section 22C(1)(b) of the [aforementioned] Act must: before commencing business, apply to SAHPRA for a license to manufacture, distribute (including import and/or export) and/or wholesale medical devices or IVDs; and appoint and designate an authorized representative who must reside in South Africa and be responsible to SAHPRA for compliance with the Act.
The applicable legislation also prescribes that:
- Medical devices (including both general and in vitro diagnostic ones) should not be manufactured by an entity that has no valid establishment license obtained following the respective procedure;
- An establishment license issued following the current regulatory framework remains valid for a limited period, hence, should be renewed before the expiration date, while the renewal could be subject to an additional fee payable by the license holder.
Renewal Process: Documents to be Submitted
The authority further provides a list of documents to be submitted by an entity applying for the renewal of a medical device establishment license. According to the guidance, the documents to be submitted should include the following ones:
- The application form is based on the type of activities undertaken by the entity, signed by the authorized person;
- Cover letter;
- Quality Manual (if the applicant is a medical device manufacturer or distributor);
- Site Master File (if the applicant is a wholesaler);
- An ISO 13485:2016 Quality Management System certificate issued in the name of the applicant entity;
- For the applicants that do not have a certificate as described hereinabove, the appropriate declaration of compliance should be provided indicating that ISO-compliant quality management system has been duly implemented, and the appropriate certificate will be provided without undue delay;
- CV of the authorized representative;
- Copy of a medical device establishment license an entity already holds at the date of submission;
- Proof of payment of annual license retention fees;
- Proof of payment of the Medical Device Establishment license renewal fee;
- Additional documentation could be necessary to facilitate the review process.
According to the guidance, an application for medical device establishment license renewal should be submitted by the license holder no later than 90 days before the date when the initial license expires. However, the authority also mentions that a grace period of 90 days is available for the license holders who have missed the said term and haven’t applied for renewal in time. The application should be submitted in electronic form via email. Should the submission dossier contain large files, they can be submitted via secure electronic document transfer.
As explained by the SAHPRA, it will take between 4 and 8 weeks for the authority to process the renewal application. The authority also encourages the applicants to ensure the submission dossier is complete to avoid additional delays. In case of any questions raised by the authority, the applicant will have 5 business days to provide a substantial response.
In summary, the present SAHPRA guidance documents provide an overview of the medical device establishment license renewal process, and also describe in detail the structure of the application and the way it should be submitted. The scope of recommendations provided by the authority also covers the applicable timelines and additional aspects to be considered by all the parties involved in operations with medical devices.
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