Software as a Medical Device (SaMD) is becoming increasingly essential in modern healthcare. A Software as a Medical Device simply refers to any software intended for medical purposes without being part of a physical medical device and can perform medical functions independently such as diagnose, treat, mitigate, or prevent diseases. SaMDs may include in-vitro diagnostic (IVD) medical devices; software that runs on general-purpose computing platforms; and software that functions as a module within another medical product. Also, mobile applications that meet these criteria are also classified as SaMD.

In order to ensure public health, safety, and effectiveness, all SaMD products intended for use in Nigeria, whether manufactured or imported, must be registered with the National Agency for Food and Drug Administration and Control (NAFDAC).

In this article, we provide a clear, step-by-step guide for importers and manufacturers on the registration process of software as a medical device.

Categorization of Software as a Medical Device (SaMD)

The categorization of Software as a Medical Device (SaMD) is based on its definition statement and its impact on healthcare decisions and patient outcomes. For example, software that helps diagnose a life-threatening disease (like cancer) will be in a higher category than an app that tracks daily fitness levels.

There are four categories of SaMDs based on the levels of impact on the patient or public health where accurate information provided by the SaMD to treat or diagnose, drive or inform clinical management is vital to avoid death, long-term disability or other serious deterioration of health, mitigating public health. Even when integrated with other devices or systems, each SaMD is categorized independently based on its own definition statement.

The four categories (I to IV) reflect the level of risk, with Category IV having the highest impact on health and public safety. If a SaMD is used for multiple conditions, it is classified at the highest relevant category; while Category I has the lowest. A calorie counter or fitness tracker app. For example, an app that reminds users to take medication or a software that logs blood pressure readings without making treatment recommendations are considered low risk SaMD; a dermatology app that classifies skin conditions for review by a healthcare provider will be considered moderate or medium risk SaMD; and a radiology imaging analysis tool that assists in detecting tumors is considered high risk SaMD.

Furthermore, any changes to the SaMD that affect its function, will require a reassessment of its category.

Below is a summary of the categorization at a glance.

Steps to take to Register a Software as a Medical Device with NAFDAC

Step 1: Prepare and Submit Application Letter

The first step is to write an application letter on the company’s letterhead to the address below:

The Director-General (NAFDAC),

ATTENTION: The Director, Drug Registration and Regulatory Affairs (DR & R) Directorate, Ground Floor, NAFDAC Office Complex, Isolo Industrial Estate, Oshodi-Apapa Express Way, Isolo, and Lagos State.

The online application form is also to be purchased, completed and downloaded from the NAFDAC Product Registration Website. Note that a separate application form is to be completed for different products. Some details to be included in the form include:

1. Manufacturer’s Information such as Name of the Company, full location address of the factory, email address, and current phone no. & fax no., the details of contact person overseas (name, telephone no., email address); name of airport closest to the location; and guide map illustrating the shortest land/air route to the factory overseas (where applicable)
2. Local Company’s Tax Identification Number (TIN)
3. Details of Applicant, such as; name, contact, address, qualification, job title, warehouse address, etc.
4. Name(s) of software
5. Details of the software, including types and category of software, medical device group or medical device family.

Step 2: Upload the supporting documents on the NAFDAC Portal

The following are supporting documents that must be uploaded on the NAFDAC portal.

1. End User License Agreement (EULA)
2. Notarized Declaration
3. Trademark registration certificate for the brand name
4. Product labels meeting NAFDAC requirements
5. Clinical Evaluation
6. Evidence of approval by any other national regulatory agency (if available)

Step 3: Review of Application by NAFDAC

Upon satisfactory documentation review by NAFDAC, an evaluation report of the products is presented to the Food and Drug Registration Committee (FDRC).

Step 4: Approval and Issuance of Certificate by FDRC

Upon the FDRC meeting for a review and approval of all documents, an electronic Certificate of Product Registration is issued to the Applicant via the NAPAMS platform.

What is the Validity of NAFDAC Certificate

The NAFDAC certificate of registration is valid for five (5) years and subject to renewal.

What are NAFDAC’S Labeling Requirements for Imported SaMD?

Generally, the Labelling of a SaMD, whether manufactured or imported to Nigeria, should be informative, accurate and in conformance with NAFDAC Labelling Requirements for Medical Devices and any other relevant regulation. All imported SaMD must include:

1. Device name
2. Manufacturer’s name and address
3. Unique device identifier (e.g., model or serial number)
4. Family or medical device family group

How Long Does It Take to register a software as a Medical Device with NAFDAC?

The timeline for product registration; from acceptance of submissions to issuance of Registration Number, is one hundred and twenty (120) working days, provided that all documents are provided timely and in their correct formats; and compliance directives are responded to within 90days.

Conclusion

NAFDAC will not accept applications for products listed on the Federal Government Import Prohibition List.

Also, it is imperative to note that a successful registration of a software as a medical device does not grant an advertisement permit of the product. Advertising permit is granted by the Registration and Regulatory Affairs Directorate, after careful evaluation of the claims made to ensure that the software correspond to the approvals given.

Kindly contact Firmus to register your software and any other medical devices with NAFDAC.