Posted by Before 2017, a significant part of the Indian medical device market was unregulated. It limited access to safe and high-quality devices for the target patient group. However, this changed in 2017 when the Ministry of Health and Family Welfare introduced the Medical Devices Rules.
MDR 2017 grouped medical devices into Single, Family, Group, System, In vitro diagnostics Test Kit and In vitro diagnostics cluster. It is now essential to mention this medical device grouping in the submission for registration. This post will elaborate on medical device grouping in India so you can easily find out the category in which your device falls.
What Is Medical Device Grouping?
Medical device grouping in India means registering multiple devices under one license. The different categories of medical devices are specified as per manufacturer, intended usage, and the relation between the constituent devices. These devices share a particular purpose or technology. As a result, the devices are applicable for single and not separate licenses.
Why Is Medical Device Grouping Essential in India?
Since there are multiple medical devices, grouping helps save fees and processing time on registration, which is crucial for manufacturers and importers. Moreover, medical device grouping facilitates compliance with regulatory under the Medical Device Rules 2017.
If your medical devices are not grouped, the Central Drugs Standard Control Organization (CDSCO) will not register them. Here are the key advantages of medical device grouping in India for manufacturers and importers:
- Streamline the process of medical device registration and license approval.
- Minimize the amount of time spent making medical devices that enter the market.
- Facilitates uniformity in compliance and in meeting all regulatory standards.
- Reduce document preparation and submission fees for getting licenses for multiple devices.
- Reduce compliance cost associated with registration of multiple devices.
Medical Device Grouping in India
Medical devices are grouped into Single, Family, Group, System, In vitro diagnostics Test Kit and In vitro diagnostics cluster.
1. Single
A single medical device is a medical device sold as a distinct packaged entity and does not meet the criteria for family, IVD test kit, system, IVD cluster or a group. It may be sold in a range of package sizes.
The medical devices that cannot be assigned to family, IVD test kit, system, IVD cluster or a group must be licensed separately.
The medical devices which are a part of a group must be licensed separately before it sold separately as individual medical devices.
Example:
- Condoms are sold in package of 3, 10 or 16 can be licensed a single medical device application.
- A company that assembles and licensed a first aid kit has now decided to also supply each of medical devices in the first aid kit individually. In such cases, each medical device supplied individually must be licensed as a single medical device.
2. Family
A medical device family is a collection of medical devices and each medical Device:
- is from same license holder;
- is of same risk classification class;
- has a common intended use;
- has the same design and manufacturing process;
- has variations that are within the scope of the permissible variants.
The characteristics of a medical device may be considered as permissible variant under clause (I), if –
- the physical design and material of construction of the medical device are the same or very similar;
- the manufacturing processes, including sterilization method, for the medical devices are the same or very similar;
- the intended purpose of medical devices is the same; and
- the risk profile of the medical device, taking into account the above factors are same
Example:
- Condoms that differ in colour, size and texture but are manufactured from the same material and manufacturing process and share a common intended purpose can be licensed as a Family.
- Spherical contact lens with additional features of UV protection can be licensed as part of a Family, as this feature does not affect the basic design or manufacturing of the lens.
- Contact lens are available as toric lens and spherical lens. These products have different intended purposes and performances. They are designed and manufactured differently. Due to these differences, they shall not be considered as members of a Family.
3. Group
A medical device Group is a collection of two or more medical devices, supplied in a single package by same license holder, which are:
- sold under single proprietary Group name; and
- a common intended purpose.
The medical device in the Group may have different proprietary name and intended purpose and designed and sold by different license holder.
The collection of medical devices in a Group may differ in the number and combination of products that comprises each Group, while maintaining the same proprietary Group name and Group’s intended purpose.
The medical device in a Group is supplied for use in another Group, such a medical device shall be included in the application of that other Group.
Example: A first aid kit consisting of medical devices such as bandages, gauzes, drapes and thermometers, when assembled together as one package, can be licensed as a Group.
4. System
The medical devices comprises system, that are:
- from same license holder;
- Intended to be used in combination to complete a common intended purpose;
- Compatible when used as system; and
- sold under single proprietary system name;
The constituent component in a system which is supplied for use in more than one System, such constituent components shall be included in the application for licence for each of other System.
If the several system fulfil the conditions, as specified in clause (b), to be grouped as Family, they may be licensed as family.
Example:
- A hip replacement system comprising of femoral and acetabular components can be licenced as system. The components must be used in combination to achieve a common intended purpose of total hip replacement. The size of component may vary.
- A glucose monitoring System comprising of a glucose meter, test strips, control solutions and linearity solutions can be licenced as a System
5. In Vitro Diagnostics Test Kit
An in-vitro diagnostics kit is a device that consists of reagents or articles which are:
- from same license holder;
- intended to be used in combination to complete a specific intended purpose;
- sold under single proprietary Test Kit name; and
- compatible when used as a Test Kit;
An in-vitro diagnostics kit does not include the instruments, such as analysers, need to be perform the test.
Individual reagents or articles can be supplied separately as replacement items for kit. If the reagents or articles in a Test Kit are supplied for use in more than one Test Kit, such reagents or articles shall be included in the application of the other Test Kits.
Example:
- Human Immunodeficiency Virus (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 licensed as Test Kit. These reagents and articles can be supplied separately as replacement items for that particular Test Kit.
6. In Vitro Diagnostics Cluster
An in-vitro diagnostics cluster comprises of a number of in-vitro diagnostics reagents or articles which are:
- from same license holder;
- of a common methodology;
- sold under single proprietary name; and
- compatible when used as a Test Kit.
Challenges Faced by Medical Device Importers and Manufacturers
The medical device industry in India has grown a lot in recent years. However, importers & manufacturers continue to encounter challenges that prevent them from experiencing growth similar to those in other countries. They face several challenges in grouping medical devices and acquiring licenses. The following are the major hurdles that need to be resolved:
- The rules for Indian medical devices are quite complex. The medical device grouping rules by MDR are still not properly understood by new manufacturers/ Importers. It increases the time and cost involved in registering medical devices.
- The regulatory guidelines are not followed consistently at the state level. Inadequate infrastructure and resources to check compliance create disparities in regulatory practices.
The many challenges necessitate manufacturers to take the help of trusted regulatory solutions providers. Dueran Consultant’s seasoned regulatory experts will fast-track your compliance with CDSCO regulations, the registration process, and license approval so you can enter the Indian market successfully.
Conclusion:
Medical device grouping by Dueran Consultant‘s simplifies the registration process of devices. There are six major grouping categories, each with their own requirements. Medical device Importers & Manufacturers must identify a group for their devices to prevent them from lengthy registration processes.
You can get complete assistance in this process from Dueran Consultant. Our team will help you every step of the way to obtain an import license, manufacturing license and post-approval registration support.
Frequently Asked Questions (FAQ’s)
What are class A and class B medical devices?
Low-risk devices like thermometers that don’t need a conformity assessment belong to class A. Class B medical devices are low-to-moderate-risk devices, like pregnancy self-tests.
What are class C and D medical devices?
Class C devices have high risk as they come into contact with the bodily fluids. An example is bone fixation implants. Class D medical devices are very high-risk devices, like defibrillators and pacemakers.
