Permission to Import a New Medical Device (MD 26/27)
The market for medical devices in India is huge and has been growing steadily in recent years. A manufacturer from India must have both the registration certificate and the import license to import any medical devices into India. If a company wants to import its medical devices into India but does not already have a registered office, then a CDSCO-approved Indian agent must be appointed.
In India, registration and a license are required for the import of medical devices. The approval of a competent body is necessary for the import of medical devices into India. The primary goal of device imports into India is to supply safe, effective, and high-quality products that comply with the highest standard of scientific development and regulatory processes. Operon Strategist provides high-quality consultancy services for medical device import licenses.
You can also check our service page on the CDSCO import license for more details.
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As per the medical device rule 2017, notified medical devices need to submit an application using form MD 26. The FORM MD 26 is required to grant approval for the importation of these medical devices.
What are CDSCO Forms MD 26 and 27?
Forms MD26 and MD27 are the names of the forms that a manufacturer or business owner can use to file an application and request permission to import of a new medical device into the country. This medical device must be new to the Indian Market.
What Is the Difference Between MD 26 and MD 27?
MD26 is a sort of application form that is required to import medical devices that do not have predicate medical devices in India, whereas MD27 is a permission form to import the devices for sale or distribution in the market.
One of the major benefits of this license is that CDSCO ensures that the new product coming into India is extensively validated and verified for its intended purpose. When CDSCO certifies a medical device, it passes quality assurance testing at an authorized laboratory & has a quality certificate. This also provides the best results for the class that it represents. These types of qualified devices are safe to use and sell in the market
Who Can Apply for New Medical Device Import License(MD 26/27)?
As per the CDSCO guidelines the Authorized Indian Agent who have license to manufacture medical devices for sell or distribute or wholesale license can apply for this license. Applicants need to apply to CLA (Central License Authority) via online portal of CDSCO
What Is the Procedure for Applying for an Import License for New Medical Devices?
Follow these simple steps to submit an application for a new medical device import license:
- Evaluate the product as per Indian MDR 2017
- Classify your product based on risk category
- Follow the checklist of form MD 26 and prepare the documents
- Appointment of Authorized agents
- Online registration
- Payment of fees
Simplify Medical Device Import License Process With Operon Strategist.
How Can an Operon Strategist Help You?
We support product understanding and classification, documentation preparation, submission, and licensing with CDSCO. Our team of experts expedites the overall process strategically and ensures the license in the best timelines.
Contact Operon Strategist for expert guidance and quality-assured consultancy services. Feel free to WhatsApp or Call +91 9370283428 or enquiry@operonstrategist.com
