Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the way the provisions thereof should be interpreted and followed by medical device manufacturers and other parties involved in operations with medical devices.

Regulatory Background 

According to the applicable legislation, any medical devices intended to be marketed and used in the country should be subject to mandatory prior registration. The regulatory approach to be applied for each particular medical device depends on its complexity and specific features. It is stated that the various components can be sold as separate components, individually customized packs, or groups and can be categorized as Single, Family, System, Procedure Pack, and IVD. When applying for marketing approval, an interested party should indicate the particular category to be applied.  The recommendations provided in the present guidance document should be considered by both local and foreign medical device manufacturers, as well as their authorized representatives.  First of all, the guidance provides definitions of the most important terms and concepts used in the context of the guidance including, inter alia, the following ones: 

  • Global Harmonization Task Force – countries working to achieve harmonization in medical device regulation among themselves. These countries are Australia, Canada, Japan, the USA, and the EU/EFTA.
  • Generic proprietary name – a unique name given by the manufacturer to identify a medical device as a whole product, also known as the trade name or brand name.
  • Accessory – a product intended specifically by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose. 

Apart from the ones listed here above, the document also provides definitions of such terms as “medical device”, “in-vitro medical device”, “authorized representative”, and “surgical instruments”. 

Building / Grouping Criteria for non-IVD Medical Devices 

As it was mentioned before, there are four types of applications, namely:

  1. Single medical device;
  2. Family of medical devices;
  3. System:
    1. Medical device system;
    2. Medical device system group;
  4. Procedure pack of medical devices. 

The present DGP&DC guidance further describes each of the aforementioned submission types in detail.  A single medical device stands for a separate product with a specific intended purpose, placed on the market in a separate package. Depending on its design and features, there could be various versions of the devices that differ in size or color. For each such device, a separate application is required. The guidance provides several examples demonstrating the particular way the aforementioned approach should be applied:

  • A software that could be operated on different devices is a single medical device.
  • A component of a first aid kit placed on the market as a separate product is a single medical device.
  • Identical products packaged together (e.g. gloves), could be placed on the market as a single medical device as well. 

Family of medical devices stands for a group of medical devices that are made by the same manufacturer, that differ in only shape and features, that have a similar design, and that have the same common intended use. The guidance further outlines the particular criteria to be applied to determine whether the medical devices could form a family. According to the guidance, such medical devices should be manufactured by the same manufacturer, be assigned to the same class under the applicable risk-based classification, be placed on the market under the same generic proprietary name, be initially intended for the same purpose, and have a similar design. It is important to mention that any medical devices within a family of medical devices should be within the scope of the permissible variants. The document also mentions that in the case of surgical instruments, specific criteria should be applied.  As it is stated in the guidance, an applicant is allowed to include accessories to medical devices within the same application, provided such accessories are intended to be used only with the particular medical device in question. In case the manufacturer decides to place such accessories on the market separately from the initial device, a separate application would be required.  Examples of a family of medical devices include cardiac catheters that are available in a different number of lumens, lengths, and diameters. The authority explicitly states that medical devices that are not intended for the same purpose are not eligible for placing on the market as a family of medical devices. 

System 

According to the guidance, a medical device system comprises of many constituent components to complete a common intended purpose, provided such components are manufactured by the same manufacturer, compatible with each other, and placed on the market as a system, while the labeling and documentation accompanying each of the elements explicitly state that they should be used together.  The authority additionally emphasizes that the class of the entire system under the applicable risk-based classification should be determined depending on the highest applicable risk for each of its components. In case there are accessories initially intended to be used with the system, they could be included in the same application as well, while for placing such accessories on the market as separate products separate applications would be required.  Medical device systems group could be placed on the market under a single application provided all the systems included are manufactured by the same manufacturer, assigned to the same class under the risk-based classification, and fall within the scope of permissible variants. Additional criteria to be applied refer to the intended purpose, design, manufacturing process, and generic proprietary name. 

Procedure Pack 

According to the DGP&DC guidance, a medical device procedure pack stands for a collection of two or more medical devices, assembled to perform a certain procedure as one packaged by a manufacturer. It is important to mention that the devices included in a procedure pack could be manufactured by different manufacturers, and their designs could be also different. At the same time, they should have a common package and label. To market each of the components of a procedure pack as a separate product, the manufacturer shall submit a separate application; while in case of placing them on the market in other procedure packs, they should be included in applications for such procedure packs.  In summary, the present guidance provides an overview of the applicable grouping/bundling criteria and highlights the most important aspects to be considered. The document also provides examples of medical devices and describes the way they could be placed on the market. 

How Can RegDesk Help?

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Sources:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers


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