When you want to import any of the medical devices then you must not be aware of the license and application process. Just to make you aware of regulatory norms here we conduct information on FORM MD 14 CDSCO.
DO YOU KNOW WHAT IS MD 14 & IS THIS REQUIRED IN YOUR BUSINESS TOO?
No, Need to worry with the help of the mentioned information you can simply understand for what purpose it is required.
MD 14 is an application that is required to obtain a license of import for medical devices. India’s medical device sector operates under stringent regulatory norms for the safety and security of medical devices. One of the aspects of this regulatory framework is the requirement for obtaining a specific license for various purposes. Among these, Form MD 14, regulated under the Medical Device Rules, 2017, plays a vital role.
Form MD 14 CDSCO
Form MD 14 is an application for an import license. It is required to legally import notified medical devices into India. The application for the MD 14 is submitted under the Medical Device Rules, 2017. The license is mandatory for Class A, B, C, and D medical devices.
Once the application of Form MD 14 is approved the CDSCO department will issue MD 15 Import License. This will allow the authorized Indian agent to import the medical devices.
Who Needs To Apply For The Form MD 14 Application?
The below-mentioned categories must apply for the MD 14 application to grow their business in India:
- Foreign manufacturers looking to import medical devices into India.
- Indian distributors or authorized agents representing foreign manufacturers.
- Companies engaged in the trade of medical equipment.
What are the Eligibility Criteria for a Medical Device Import License?
When you are willing to import medical devices to India then a foreign manufacturer must have:
- You must appoint an Authorized Indian Agent (IAR) who holds a valid CDSCO Wholesale Drug License.
- Ensure that the companies and their products meets all the CDSCO safety & quality regulations.
- Provide required regulatory approvals from the country of origin (Free Sale Certificate, GMP, ISO 13485, etc.).
Steps To Apply For Form MD 14 Registration
All the importers of medical devices must understand the process of MD 14 Registration in India. This will help to regulate medical devices in India freely:-
Classification of Medical Device
The first step in importing a medical device is to determine if it requires registration under the Medical Device Rules of 2017 and whether it is classified as a regulated or unregulated item. In circumstances where registration is required, an assessment of the medical equipment must be performed using the risk-oriented categories indicated above.
Appointment of an Authorized Indian Agent (IAR)
A foreign producer cannot apply directly for a medical device import license. The regulations state that the manufacturer does not have the power to approach CDSCO for application submission directly. As a result, the manufacturer is required to work with an approved license agent, who might be either a business or an individual. In this case, the manufacturer must provide this agent power of attorney, allowing them to apply in the manufacturer’s name and contact the licensing body on the manufacturer’s behalf, submitting relevant data and papers.
Submission of Application using Form MD 14
Any medical device importer who wishes to register through the online portal must complete Form MD 14 and submit all required attachments. However, if the manufacturer/importer’s objective is to get the registration for training or research purposes, an application in form MD-16 must be filed, and the appropriate license certificate in form MD-17 will be provided. Before filing this application on behalf of the foreign manufacturer, the importer’s authorized agent must hold a Form 20 license for stock and sale, as well as a Form 21 B license for sale and distribution under the Medical Device Rules of 2017.
Grant of MD Import Registration in Form MD-15
After reviewing the application, if the authorizing authority believes that the applicant’s medical device is genuine and made by the pre-specified parameters, it may authorize registration and notify the applicant in the form MD-15. Any approval or rejection of the application will be communicated via the registered email address.
Documents Required For Form MD 14 License
Here are the documents mentioned below:-
- Certificate of Incorporation/partnership deed
- A valid copy of the Medical Device wholesale license
- Power of attorney duly notarized
- Notarized copy of overseas manufacturing site or establishment or plant registration
- Animal studies Preclinical data
- Stability validation data, Clinical evidence
- Post Marketing Surveillance data
- Batch Release Certificates or Certificates of Analysis of finished product
- Biocompatibility validation data
- Medicinal substances data if the device contains Drug
- Biological Safety (TSE/BSE), Sterilization Validation data
- Label and IFU
- Device Design and Manufacturing process with flow chart
- Essential Principles Checklist
- Copy of the Device Master File
- Details of the Authorised Indian Agent
- ISO 13485 certificate for quality assurance
- Copy of latest inspection/audit report
- Reference to predicate or previous generations of the device
- Certificate of full quality assurance
- CE certification for designs
- Statement of Compliance
- Free sale certificate, duly apostille/notarized
- Regulatory approvals, if necessary
- A copy of the Plant Master File
What are the Common Reasons For the Rejection of Form MD-14?
Here are the common reasons which your application must be rejected:
- Incomplete documentation
- Incorrect classification of the device
- Non-compliance with CDSCO regulations
- Failure to appoint an Indian Authorized Representative (IAR)
Can You Amend Form MD-14 After Submission?
Yes, You can amend the MD 14 application before approval if CDSCO requests modifications.
Can an Import License be Transferred to Another Entity?
No, the MD 15 is a non-transferable license. A new entity must need to apply separately.
What are the Common Reasons for the Rejection of Form MD-14?
The common reasons for the rejection of the Form MD 14 Application are as follow:
- Incomplete Documentation
- Incorrect Classification Of the Device
- Non-Compliance With CDSCO Regulations
- Failure to appoint an Indian Authorized Representative (IAR)
Role of ELT Regulatory Services
ELT Regulatory Services is one of the leading companies in the world of legal. Anyone can take free business consultation with a few easy steps. Professionals here are well-experienced in the field and always ready to help. To take any advice from ELT regulatory services simply call on the no. mentioned above on the page.
FAQ (Frequently Asked Questions)
What is the medical device import license?
The medical device import license is a regulatory authorization provided by the Central Drugs Standard Control Organization (CDSCO) to permit the importation of medical devices into India.
Can I import medical devices without a license?
You can only import Medical Devices into India with a proper Importer License.
Are there any specific regulations or guidelines to comply with for importing medical devices into India?
Yes, Medical Device Importers in India must follow all the Medical Device Rules. Covering aspects are labeling requirements, device qualification, post-market surveillance, and quality management systems.
How do I apply for a medical device import license in India?
To apply for a Medical Device Import Licence in India, one has to submit all the important documents on the online CDSCO online portal.
Can there be multiple importers for the same product?
Yes, there can be Multiple Importers for similar products, but keep this in mind to fulfill all the requirements.
