A predicate device is a device that most closely resembles the medical device in terms of indications of use and technological characteristics. A predicate medical device has been registered/approved in India. It has the same indications/intentional use, material of construction, and design characteristics as the device being proposed for registration in India. New medical devices are those that have been notified but have not yet been registered in India. A predicate medical device must be registered or approved in India to be considered a new medical device. The Medical Device Advisory Committees (MDAC) are asked for feedback on these medical devices’ safety, efficacy, necessity, and desirability.
Importance of Predicate Device
The importance of predicate and selecting the suitable predicate device from India is essential, and it must be updated by the Central Drug Standard Control Organization CDSCO, which determines product efficacy. The registration process can take around six to nine months. When the products do not have a predicate in India, the processing time will be extended, and a special committee is supposed to be formed to determine the safety and efficacy of the products for the Indian market. Predicate comparisons submitted to CDSCO must have a similar Product description, Intended use, design, Material of construction, Advantage and disadvantage, and Contraindication, all required when compared with products that must be registered.
The device classification from CDSCO, which generally classifies the product as CLASS A, CLASS B, CLASS C, and CLASS D, is based on the risk involved in product usage. Product Code is another critical category in locating the predicate device, regardless of whether they have already registered with CDSCO Classification of the device. Product code is essential in finding predicate devices. A search of the Product code and classification database will yield the device’s classification. This classification database contains the following information: common name, product code, registration number, manufacturer information, and Indian agent details.
Predicate Device as per MDR, 2017
Section 3 (zm) of the Medical Device Rules 2017 defines a predicate device as “a device- first time and first of its kind, approved for manufacture for sale or import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for a licence in India”
The existence of a registered predicate device in the market affects the factors like risk classification, grouping, time and costs. If a medical device is having a medical device registered in India, then form MD-14 is for the application process for the import license. However, if the medical device does not have a predicate device registered along with it, then the data like pre-market data or post-market clinical data from India can be required along with the registration application as decided by the Subject Expert Committee (SEC) on a case-to-case basis.
Conditions for a medical device to be substantially equal to a predicate device
According to the medical device rules 2017, the application for grant of permission to conduct clinical investigation applies a condition, which says that any Medical device that requires any clinical investigation but is claiming the substantial equivalence to a predicate device cannot be marketed unless the Central Licensing Authority approves it. About this rule, for a device to be substantially equivalent to a predicate device, it has to comply with specific conditions. The conditions which are to be fulfilled to make a device substantially equal to a predicate device are-
- The device should have the same intended use and technological characteristics.
- The device can have the same intended use. Still, different technological characteristics, and should it should display that the device is safe and it is as effective as the predicate device.
It is not necessary for a proposed medical device and the predicate device to be identical to be substantially equal. The factors responsible for the substantial equivalence are-
- Intended use
- Energy used/ delivered
- Chemical composition
- Manufacturing process
- Standards, etc.
Conditions of import/ manufacture of the device without a predicate device
To obtain permission to import/manufacture a medical device that does not have its predicate device, there are specific standards to be followed. An application to obtain approval for import/ manufacture of such device is made after completing its clinical investigation to the Central Licensing Authority in MD-26. The form is to be submitted by the authorised agent of the importer/manufacturer, along with the fees specified in the second schedule and the required documents as per part IV of the fourth schedule.
If the medical device does not have a predicate medical device, indicated in specific problems, the clinical data or the animal data shall be omitted, deferred or abbreviated, as per the decisions of the Central Licensing Authority.
The problems for the aforementioned are life-threatening, serious diseases or diseases of particular importance to Indian health, national emergencies, extreme urgency, epidemics and medical devices indicated for conditions, diseases for which there is no therapy.
The Central Licensing Authority may grant permission for import or manufacture of a device which does not have a predicate medical device, in the form MD-27. The CLA may also reject the application within 120+30 days (Including an extension period) from the date of the application. The rejection should be made in writing, with the reasons for the rejection.
Conditions where the device does not have a predicate device and new in-vitro diagnostic medical device
As per MDR 2017, there are conditions for obtaining permission for the purpose of importing or manufacturing a medical device that does not have any predicate medical device and a new In vitro diagnostic medical device. As per rules 63 in form MD-27 and as per rules 64 in form MD-29, permission for the same is provided, subject to certain conditions. The conditions are as follows-
- The medical device must meet the specifications included with the application.
- From the date of market launch, the permit holder of Form MD-27 must submit the Periodic Safety Update Report to the Central Licensing Authority. This report must be submitted every six months for the first two years, then annually for the next two years.
- The permit holder must notify the Central Licensing Authority of the date the medical device will be introduced to the market.
- The permission holder of Form MD-27 shall report any suspected unexpected serious adverse event to the Central Licensing Authority within fifteen days of being aware of the event.
The healthcare sector in India is rapidly expanding and is predicted to reach $280 billion by 2025. India has one of the top 20 global markets for medical devices. By 2025, its estimated value, currently $5.2 billion, will rise to $50 billion. However, India does not produce many medical devices domestically and still imports about 70% of them. Medical device manufacturing and maintenance are highly regulated processes. There were no specific medical device laws in India; instead, the 1940 Drugs and Cosmetics Act governed devices. Indian Medical Device Rules, 2017, the new regulations for medical devices in India, were released by the Central Drug Standard Control Organization to fill this gap. The factors that have contributed to the surge in the medical industry include changes in disease burden, shifting consumer preferences, a growing middle class, and an increase in health insurance, medical support, infrastructure development, policy support, and financial incentives.
Read our Article:Grant of Test License for Import under MDR, 2017