In the ever-evolving world of healthcare, the development and introduction of  new medical devices play a pivotal role in enhancing patient care and advancing medical science. However, before such innovative devices can reach healthcare professionals and patients, they must achieve compliance with a comprehensive Regulatory framework. In India, securing a manufacturing or import license for new medical devices is a multifaceted process that involves compliance with stringent rules and regulations. In this blog, we shall take a deep dive into the intricate procedure of obtaining the necessary permissions for innovative medical devices without a predicate, shedding light on the key steps and considerations for manufacturers who are looking to bring novel medical technologies to the Indian market.

Understanding the Regulatory Landscape for a Medical Device Without a Predicate

If a medical device falls under the category of a “medical device with no predicate device” and an individual or a company wants to manufacture or import it in India, they need to follow these procedures and requirements for obtaining permission:

  • Application for Permission: If a medical device does not have a similar/predicate device available in the market, individuals or companies seeking to import or manufacture such a device must submit an application for permission. This application should include data from clinical investigations conducted as per Chapter VII. It is to be submitted in Form MD-26 to the Central Licensing Authority. The application should be accompanied by a specified fee and information detailed in Part IV of the Fourth Schedule.
  • Special Considerations: In certain critical situations, such as life-threatening diseases, serious illnesses, diseases that are of significant relevance to India’s health situation, national emergencies, extreme urgency, and epidemics, or for medical devices addressing conditions without existing therapies, the requirements for animal or clinical data may be modified, deferred, or omitted, as deemed appropriate by the Central Licensing Authority. For Class A investigational medical devices, clinical investigation data may not be necessary unless the Central Licensing Authority, for specific reasons, deems such data essential.
  • Relaxation for Devices with Drugs: For medical devices that also contain drugs, requirements related to animal toxicology, reproduction studies, teratogenic studies, perinatal studies, mutagenicity, and carcinogenicity may be relaxed if the drugs have already been approved and marketed in India and are supported by sufficient published evidence regarding their safety.
  • International Approval: Clinical investigation results need not be submitted for investigational/new medical devices that have been approved by Regulatory authorities in countries like the United Kingdom (UK), the United States (US), Australia, Canada, or Japan, and have been on the market for at least two (02) years in those countries. However, certain conditions must be met, including detailed evidence citing that that there are no theoretical differences in the behaviour and performance of the Indian population and an undertaking to conduct post-marketing clinical investigations according to the Central Licensing Authority’s approved protocol.
  • Granting or Rejecting Permission: The Central Licensing Authority, upon reviewing the information provided in the application under sub-rule (1), can grant permission to either import or manufacture the medical device (in Form MD-27) or reject the application. This decision must be made within one hundred and twenty (120) days, with the possibility of extending it for an additional thirty (30) days.
  • Incomplete Information: If the information in the application is inadequate, the Central Licensing Authority must communicate this to the applicant in writing within the specified time frame. If the requested information is not provided by the applicant within ninety (90) days from the date of intimation, and if it is determined that the information could have been provided within that time, the application may be rejected.
  • Appeal Process: If the applicant does not receive permission or if their application is rejected within the specified period, they have the option of appealing to the central government. The central government will then conduct an inquiry and may pass orders within sixty (60) days of the appeal.

Regulatory Compliance for Innovative Devices

To manufacture or import a medical device without an equivalent reference, individuals or companies must fill out the relevant forms to ensure that novel medical devices introduced to the Indian market adhere to the essential Regulatory and safety standards.

The procedure for manufacturing or importing a medical device that does not have a comparable reference (a predicate device) is well defined. To initiate this approval journey, entities are obligated to submit an application using Form MD-26, which serves as the official request for approval to manufacture or import medical devices without a predicate. Following a meticulous review of the necessary documentation, approval is granted in Form MD-27, authorizing the import or manufacture of such devices. These devices are categorized into Classes A, B, C, or D, and a fee of Rs 50,000 is applicable for each device. The Central Drugs Standard Control Organization (CDSCO) is the central Regulatory authority responsible for overseeing this process and ensuring that the innovative medical devices launched into the Indian market are compliant with the established standards and safety requirements.

Securing approval for medical devices without a predicate in India can be a complex challenge to overcome. Stringent regulations and the demand for precise documentation underline the importance of expert guidance. Freyr’s extensive knowledge of India’s evolving Regulatory framework will help you expedite the approval process for your innovative medical devices. Our team of experienced professionals, well-versed in the intricacies of CDSCO and Indian regulations, will ensure that your submission is thorough, compliant, and ready for review.

Are you ready to expedite your medical device approval in India? Partner with Freyr and navigate the complex Regulatory terrain with confidence. Let us bring your innovation to the forefront of Indian healthcare.  Contact us today to kickstart your journey toward success!



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