How to group or bundle medical devices and submit in one application to register with EFDA
From 2018 on, Food and Drug Authority (FDA) of Ethiopia started implementing the rules of appropriate bundling of different medical devices into a single registration request application. Bundling or grouping devices is a very important strategy to enable the assessors (EFDA’s staff who have expertise in and assigned to assess the submitted registration request application dossiers) to focus on and evaluate only one similar categories of products whose safety and performance can be verified by evaluating the same technical supporting documents (such as safety and performance test reports). It also helps the applicants (business entities who request for registration of the devices) place a purchase order for any of the device in the bundled group separately after the registration request application is concluded to be satisfactory and the Marketing authorization certificate is issued. The bundling principles depend on different criteria in order to make appropriate grouping. Accordingly, for most of the bundling options, only devices from the same owner, with the same intended purpose, which fall under the same risk class, which have similar technological characteristics and manufactured by similar manufacturing processes can be bundled and submitted with the same application to EFDA’s regulated products online registration platform (Electronic Regulatory Information System, eRIS). When implementing the grouping principles, the grouped products can be applied together as one of the following grouping options:
- IVD test kits
- IVD Cluster
EFDA has developed and officially published the medical device grouping guideline in mid-2021. Therefore, any applicant or registrant who is licensed or given certificate of competence to represent the manufacturer/license holder are obliged to fully understand the guideline and make appropriate application accordingly. As the published medical device grouping guideline is more general and does not give detail principles of bundling, the Authority is expected to develop other supplementary documents (guidelines) which are specific to a category of devices to help the applicants fully understand how to make appropriate grouping of their devices and request for registration in one application. The published one and the supplementary documents to be developed are high-level documents and may not be easily understandable as they have limited examples to perceive what they are intended to explain. Therefore, this particular article is to make things more simple and understandable for the applicants by incorporating relevant examples under each grouping option listed above.
Unlike medicines, applying medical devices for registration is not easy and is a bit tricky. This is because the intended use of each medicine is independent to others (eg. a paracetamol does not need to be packed and sold with Ibuprofen for headache pain relief). Each medicine is applied and evaluated separately. In contrary, the intended medical purpose of most medical devices are achieved by combination of different components, accessories and consumables. Therefore, the primary effort of any applicant when applying for medical devices should be:- which grouping option is appropriate for my device(s)?, identifying the device’s common name or generic name (eg. Digital Diagnostic X-ray system), identifying the trade or brand name by which this device is being sold/marketed, identifying the available models, sizes and pack sizes of the device which can be applied together and adding them to the system one by one, identifying its risk class, and attaching all the relevant supporting documents.
The other very important information that most applicants are missing during their device’s registration request, but that must be filled to the system during your application’s initial submission is:- accessories and spare parts (components). This is because, if you fill this information accurately and appropriately, you don’t need to interact with EFDA for import approval of such accessories or spare parts once the parent device’s registration application is approved.
A medical device that is to be sold as a distinct packaged entity that may be sold in a range of package sizes, quantity, color and does not meet the criteria for family, system, set, IVD test kit, or IVD cluster can be applied and registered separately. Examples of medical devices that can be applied as single:-
- Identical Condoms with only package size differences, examination or surgical gloves with different package sizes.
- A software that can be used with multiple CT scanners from different manufacturers can be applied as a single product.
- If an applicant wants to market any one of the component of a First Aid kit that has been previously registered as a “set”, then the applicant should apply for that component to register it as a “single”.
The basic grouping criteria that are listed in the introductory section of this tutorial also work for applying devices as single.
Think of this: In your family, you are a member just like your sisters, your brothers, your mother, and your father. Within the members, there may be differences that we may physically observe: height, color, weight, behavior, etc. These changes are still acceptable as per the grouping criteria and you would apply all your family members as one application to register with EFDA if your family were medical devices. Look at the listed grouping criteria again, all members of your family have the same goal of making your family live better life (take this as a similarity in an intended purpose), all the members are created from the same father and mother and with the same procedure (take this one as a similarity in technological characteristics and manufacturing process), any good or bad action that may be done by any of the member will directly or indirectly affect the whole family members positively or negatively (take this as the same risk class). Remember that even though they meet the grouping criteria, there are still some differences just listed above. Therefore, unlike other grouping options, change in some features may be acceptable when we group devices as a family. These differences in features may include, material, structural characteristic, design, patient groups, energy source, brand name, model name or device description, area of application, additional function, additional secondary intended use/purpose. In addition, the general permissible variants that are listed on the general grouping guideline are also acceptable.
Examples: Remember that I just said condoms with different package sizes can be applied as single; this is because the device is the same and there are options of packing different numbers of the same device may be for marketing purpose. Now, if the changes increase from just package size to the product’s features such as colors, sizes and textures, you no longer are allowed to apply them in one application as a single. Don’t worry, there is another bundling option for you: family.
Think of an organization. Any organization has a distinct structure which may be specific/unique to that organization. Whether it is governmental or not, it has a goal or goals that it is intended to achieve (eg. EFDA’s primary goal is to protect public health by performing different regulatory activities…). Inside any organization, there are different departments to accomplish the intended common goal. These departments have teams and individual experts who are skillful and acknowledgeable in their respective areas to achieve the organization’s goal. That means, the common goal of the departments, teams, and individuals at all levels in EFDA is to protect public health by conducting the regulatory activities assigned to them. This is called a system when we talk about it in bundling/grouping language. The special identity of this bundling option is to include two or more individuals within the group where individual’s intended purpose may be different but the general intended purpose they are intended to achieve is common. Consider a total hip replacement system:- it has three main components:- femoral head, plastic liner and acetabular cap where each component may differ in size. These three components of the system are intended to be used together for common purpose (to replace the natural hip). Therefore, these products can be applied and registered as one with a single system name (i.e. hip replacement system).
A medical devices system comprises of several constituent components to complete a common intended purpose. To submit marketing authorization applications as a single application for such members (components) of a medical device, which might have their own distinctive intended uses/purposes but bundled to complete an overall common intended purpose, the grouping criteria that are listed in the introduction of this article will be applicable. Please refer to the following flowchart to determine if your devices can be submitted in one application as a “system”. Note that:- different constituent components come together to form a system and different systems (system 1, system 2, …system n) can be applied as a “family” and submitted in one application as long as the variation within the systems are permissible.
A medical device SET is a collection of two or more medical devices, that is labelled and supplied in a single packaged unit by a product owner. The medical device SET comprises of the following:
- a single proprietary Set name;
- labelled and supplied in a single packaged unit by the product owner; and
- a common intended purpose.
For the purposes of grouping for product registration, the collection of medical devices in a Set is the CLOSED LIST of devices included in a product registration submission. This closed list of medical devices in a Set (single packaged unit) may differ in the number (quantity) and combination (permutation within the closed list) of products that comprise the Set, while maintaining the same proprietary Set name and the Set’s intended purpose.
The product owner of a medical device Set may incorporate medical devices obtained from other manufacturers/product owners as part of their Set submitted for registration to achieve the common intended purpose. In manufacturing and assembling this Set of medical devices, the evidence to substantiate the safety, quality and effectiveness of the collection of devices shall be provided in the submission. Relevant information for submission may include sterility, shelf life, evidence on use and compatibility as a Set, quality management systems, etc. Labelling, particularly the instructions for use (IFU), where applicable, shall clearly describe the common intended purpose of the Set. Only medical devices within a Set that are eventually listed on the eRIS shall be supplied on the market as a single packaged unit under the Set name.
If your devices fulfil the criteria to be applied with one application as a Set, the Set name indicated for the medical device must appear in the product label affixed on the external package of the Set. The content list of devices within the single packaged unit for supply should also appear on the external package of the Set or supplied with the Set.
Examples: – A first aid kit consisting of medical devices such as bandages, gauzes, drapes and thermometers, when assembled together as one package for a common medical purpose by a product owner, can be grouped as a Set. Please, refer to the following flowchart to easily understand if your devices can be grouped and submitted as a “SET” with one application.
5. IVD Test kits
An IVD TEST KIT is an in vitro diagnostic (IVD) device that consists of reagents or articles that are:
- from the same product owner;
- intended to be used in combination to complete a specific intended purpose;
- sold under a single TEST KIT name or the labeling, instructions for use (IFU), brochures or catalogues for each reagents or article states that the component is intended for use with the IVD TEST KIT; and
- compatible when used as a TEST KIT.
An IVD TEST KIT does not include the instruments, such as analyzers, needed to perform the test. An IVD Medical Device SYSTEM may typically consist of TEST KITs and instruments (e.g. an analyzer designed to be used with that TEST KIT). An IVD TEST KIT and its accompanying IVD analyzer can be registered and listed together as an IVD SYSTEM or the IVD analyzer can be registered and listed separately from the IVD TEST KIT(s).
Example:- An HIV Enzyme Linked Immunosorbent Assay (ELISA) TEST KIT may contain controls, calibrators and washing buffers. All the reagents and articles are used together to detect HIV and therefore can be grouped as a TEST KIT. These reagents and articles can be supplied separately as replacement items for that particular TEST KIT.
6. IVD Cluster
An IVD CLUSTER comprises of a number of in vitro diagnostic reagents or articles that are:
- from the same manufacturer;
- within risk classification A or B;
- of a common test methodology as listed in Annex II of EFDA’s General Grouping Guideline; and
- of the same IVD CLUSTER category as listed in Annex II of EFDA’s General Grouping Guideline.
The IVD CLUSTER may include analyzers that are designed for use with the reagents in the IVD CLUSTER.
A closed list of common test methodologies and IVD CLUSTER categories is provided in Annex II of EFDA’s General Grouping Guideline.
Information on all reagents or articles within an IVD CLUSTER must be submitted as part of the product registration application. Devices and articles that are listed as part of a CLUSTER can be supplied separately but solely for the registered intended purpose.
If a reagent or article is intended for multiple usage categories such that it can be grouped in more than one IVD CLUSTER, the Registrant can choose to group the reagent or article as part of any one of the IVD CLUSTERs it qualifies. Information to support all the intended purposes of the reagent or article must be submitted as part of the product registration application.
Examples:- If you have a test kit for enzyme A, a test kit for enzyme B, reagents for enzyme C, and reagents for enzyme D, then you can group them as one “IVD CLUSTER” category and submit with one application.
Please refer to the following flowchart to decide if your IVD devices can be grouped and applied as an “IVD CLUSTER”.
Please note that this article provides the general principles of grouping including the grouping criteria, related examples and decision flowcharts which will help you determine if you wish to bundle your products together in one application and know which of the grouping options lets you do so.
Grouping of some medical devices (eg. dental devices, hearing aids, IVD analyzers, etc.) may be tricky and needs more understanding than the information provided in this article. Please don’t hesitate to contact Ethiobiomedical if you need further support.