Tag: Medical Device

CDSCO Test License for Medical Devices in India

Posted on by manager

Chapters IV and V of the MDR 2017 provide detailed guidelines for manufacturers and importers seeking to manufacture or import small quantities of medical devices for specific purposes in India. These licenses enable companies to conduct clinical investigations, testing, evaluation, demonstrations, or training without the need for full manufacturing or import licenses. In this article, we provide an in-depth overview of the test license regulatory process, eligibility requirements, steps involved, necessary documentation, validity, cancellation conditions, and the benefits associated with obtaining a test license.

Eligibility for Medical Test License:

Any importer or manufacturer aiming to import or manufacture small amounts of medical devices for testing, evaluation, demonstration, or training purposes must obtain a test licence approved by the Central Drugs Standard Control Organization (CDSCO). For commercial purposes, a full import or manufacturing licence is required.

Steps to Apply for Test License:

  1. Create an account on the NSWS portal and register.
  2. Apply for approval using Form MD-16 for import or Form MD-12 for manufacture.
  3. Upload all necessary documents.
  4. Pay the prescribed fee.
  5. CDSCO will review the application form and issue a test license in Form MD-17 for import or Form MD-13 for manufacture if found satisfactory.

Documents Required:

  1. Brief description of the medical device, including intended use, material of construction, and design.
  2. Justification of the proposed quantity
  3. Test protocol/Approved clinical investigation plan
  4. Quality certificates such as QMS
  5. Labels and Instructions for Use (IFU)
  6. Undertaking stating the use of the medical device for non-commercial purpose.
  7. Undertaking from the testing laboratory confirming the provision of required facilities.
Steps to Obtain CDSCO Medical Test Licence

Applicable Fees:
1. Test license for manufacture: 500 Rs for each distinct medical device
2. Test license for import: 100USD for each distinct medical device

Validity: The test license remains valid for 3 years from the date of issue.

Cancellation of Test License: If a licensee contravenes any provisions of the rules, the Central Licensing Authority may issue a show cause notice for cancellation. The licensee has the right to appeal to the Central Government within forty-five days from the date of the cancellation order.

Benefits:
1. Facilitates innovation while ensuring compliance with regulatory standards
2. Allows companies to do product testing/ clinical investigation prior to market introduction.
3. Provides opportunity for companies to conduct internal trainings prior to full-scale commercial launch.

Conclusion:

Obtaining a test license for medical devices in India is essential for companies engaging in testing, evaluation, demonstration, or training activities. By adhering to regulatory standards and obtaining expert guidance, companies can navigate the licensing process effectively and contribute to advancing healthcare innovation in India.

Why RSI ?

Regulatory Solutions India (RSI) provides comprehensive regulatory consulting services to assist companies in obtaining test license for medical devices in India. With expertise in eligibility criteria, documentation preparation, submission, and compliance with regulatory requirements, RSI can streamline the licensing process, mitigate risks, and accelerate market entry of your medical device in India.

Contact us for all regulatory needs.

FAQ's

Test License For Manufacturing:

1. What records does the licensee need to maintain under the test license for manufacture?

The licensee must keep a detailed record of the quantity of products manufactured under the test license.

2. How should the medical device be used under the test license for manufacture?

The medical device manufactured under the test license should be used exclusively for clinical investigations, tests, evaluations, examinations, demonstrations, or training at the specified location mentioned in the license.

3. Can Medical Device Officers inspect the manufacturing premises?

Yes, Medical Device Officers have the authority to enter the manufacturing premises, with or without notice, to ensure that only authorised activities are being conducted.

4. What other records are required to be maintained by the licensee?

The licensee should maintain records of the quantity of medical devices manufactured, tested, and stocked, along with their disposition.

Test License For Import:

1. How should the medical device be used under the test license for import?

The medical device imported under the test license should be used exclusively for clinical investigations, tests, evaluations, demonstrations, or training at the specified location mentioned in the license.

2. Can the medical device be taken to places other than those mentioned in the test license?

No, if the medical device needs to be taken to a place other than those specified in the license, written permission must be obtained from the Central Licensing Authority.

What activities should the holder of the test license maintain records of?

The holder of the test license must maintain records of activities undertaken, including the name of the manufacturer, quantity imported, and date of import.

4. What documents should accompany the consignment of medical devices?

The consignment of medical devices should be accompanied by an invoice or statement showing the name and quantity of the medical devices.

5. What should be done with unused medical devices?

Unused medical devices, including in vitro diagnostic medical devices, may be exported or destroyed with intimation to the Central Licensing Authority.

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Understanding Post-Approval Changes in Medical Devices: A Comprehensive Guide

Posted on by manager

Introduction :

The introduction of a medical device into the market is a complex process that starts with necessary approval from the licensing authority. Once a device has been approved, any changes made to it can potentially impact its performance, quality, safety, and effectiveness. To address this issue, the central government has included a provision in the sixth schedule of the Medical Device Rules (2017) that requires all post-approval changes to be communicated to the licensing authority.

What are Post-Approval Changes in Medical Devices?

Post-approval changes in medical devices refer to any modifications or alterations made to a device or to any of the manufacturing steps after an import license has been issued by CDSCO. These changes may include modifications to the device's design, manufacturing processes, intended use, or indication for use. Any such changes have the potential to affect the device's performance, quality, safety, and effectiveness. Therefore, it is crucial to manage these changes effectively to ensure that the device continues to meet regulatory requirements.

Types of Post-Approval Changes

Post-approval changes in medical devices can be classified into two categories: major changes and minor changes.

1. Major Changes: Major changes refer to any changes that have a significant impact on the device's performance, quality, safety, or effectiveness. These changes include:

  • Material of construction
  • Design affecting the quality
  • Intended use or indication for use
  • Sterilization method
  • Approved shelf life
  • Name or address of licensee or manufacturer
  • Labeling excluding font type/size, color, design
  • Manufacturing processes, equipment, or testing affecting the quality
  • Primary packaging material

If any major changes are made to the device, the manufacturer/Importer must notify the licensing authority and obtain approval before implementing the changes. The changes in medical devices must be approved or rejected by the central licensing authority within 45 days, otherwise the changes are deemed approved.

2. Minor Changes: Changes to the following  are considered minor change:

  • Design which does not affect quality in respect of its specifications. Indications for use,  performance and stability of the medical device  
  • Manufacturing processes, equipment, or testing which does not affect quality of the device.
  • Packaging specifications excluding primary packaging material.

If any minor changes are made to the device, the manufacturer must inform the licensing authority within 30 days of implementing the changes. However, prior approval from the licensing authority is not required for minor changes.

Process for Managing Post-Approval Changes

The process for managing post-approval changes in medical devices includes the following steps:

  1. Identification of Changes: The first step is to identify any changes that have been made to the device. This may involve conducting an impact assessment to determine whether the changes are major or minor.
  1. Notify and obtain approval from the Licensing Authority: If any major changes have been made to the device, the manufacturer/ importer must notify the licensing authority and obtain approval before implementing the changes. The notification must include details of the changes, such as the reason for the change and supporting documents.

Post approval changes in medical devices-RSI

Conclusion:

Post-approval changes in medical devices are an essential aspect of the development process. Manufacturers must be aware of the types of changes and the process for notifying the licensing authority about the changes. By ensuring compliance with regulations, manufacturers can make necessary changes to improve the device's performance, quality, safety, and effectiveness while ensuring patient safety.
Regulatory Solutions India has a team of experienced regulatory consultants who can assist you in implementing post-approval changes and obtaining approval from the licensing authority. By working with our team, you can ensure compliance with regulations while making necessary changes to improve the device's performance, quality, safety, and effectiveness.

Don't hesitate to contact us to discuss your regulatory needs and how we can assist you.

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New Medical Device Rules in India: Registration Certificate for Sale

Posted on by manager

The Indian medical device industry is currently experiencing a significant transformation with the Ministry of Health and Family Welfare (MoHFW) introducing amendments to the Medical Device Rule 2017 to strengthen the medical devices ecosystem further.

A notification was issued on 30th Sep 22 by the Ministry of Health & Family Welfare introducing the concept of “Registration Certificate” in Form MD-42 as an alternative to the wholesale license in Form 20B & 21B to sell, distribute, or offer medical devices for sale in India. This is indeed a welcome move on two main accounts:

  1. Allows importers/distributors an easier & faster process for getting necessary approvals to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical devices.
  2. Wholesale License holders for medical device currently need to comply with drug specific storage requirements whereas this draft notification stresses on complying to requirements as applicable to the medical device being stored.

This blog will provide an overview of the new regulations and the process for obtaining a registration certificate for the sale of medical devices in India.

Key Point of Medical Devices (Fifth Amendment) Rules, 2022

The new amendment to the Medical Device Rule 2017, mandates persons or businesses to obtain a registration certificate for sale to sell, distribute, or offer medical devices for sale in India. The new rules in Medical Device Rule 2022 have been inserted after Rule 87 and are as follows:

“Rule 87(A). Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.” —

Under this sub rule, the State Licensing Authority shall appoint licensing authorities to issue registration certificates. The applicant submits the application in Form MD-41 along with various documents and fees, including a self-certification of compliance with Good Distribution Compliance and proof of identification, ownership, or occupancy, technical staff qualifications, and an undertaking to comply with storage requirements. The State Licensing Authority will grant the registration certificate in Form MD-42 if all requirements are met.

“Rule 87(B). Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.” —

Rule 87(B) outlines the conditions that must be met by the holder of a registration certificate which include prominently displaying the registration certificate, providing adequate storage space and proper storage conditions, maintaining the required temperature and lighting, purchasing medical devices only from licensed manufacturers or entities, and maintaining detailed records of purchases and sales. These records must be open to inspection by a medical device officer, who may also take samples for testing. All registers and records must be preserved for a minimum of two years, and an inspection book must be maintained in Form MD-43 for the Medical Devices Officer to record their observations and findings.

“Rule 87(C). Validity of registration certificate.” —

According to Sub rule 87(C), a registration certificate issued in Form MD-42 will remain valid permanently if the registration certificate retention fee is paid before completion of five years from the date of its issue.

“Rule 87(D). Suspension and cancellation of Registration Certificate.” —

As per the sub rule 87(D), if the holder of a registration certificate violates any provisions of the Act or rules, the State Licensing Authority can suspend or cancel the certificate by issuing a written order after giving the holder an opportunity to explain why such action should not be taken.

Steps to Obtain a Registration Certificate:

Step 1: Apply on Form 41 for the grant of a registration certificate to the State Licensing Authority (SLA).

Step 2: Upload the prescribed fees challan as per the second schedule of Medical Device Rules 2017 and amendments thereof.

Step 3: The State Licensing Authority will review the application and, if found satisfactory, will grant the registration certificate in Form 42.

If rejected, the applicant may file an appeal with the state government within 45 days of rejection.

Step 4: Maintain an inspection book in Form MD-43 for the medical officer to record their observations and findings.

Steps to obtain registration certificate for sale of medical device

About Regulatory Solutions India

Regulatory Solutions India (RSI) is a company that has been paving the way in regulatory consulting since its inception in 2011. RSI has successfully registered over 400 products in India, including medical devices, IVDs, and cosmetics across 25+ categories, such as stents, catheters, intraocular lenses, orthopedic implants, ablation devices, surgical dressings, hypodermic syringes and needles, and many more. With satisfied clients from 15+ countries, RSI offers a unique combination of technical, strategic, and project management support, all backed by their extensive industry experience.
At Regulatory Solutions India, we understand that the process of registering products can be daunting, which is why we offer comprehensive support throughout the entire lifecycle. We assist companies in preparing their applications and navigating the complexities of the central licensing authority in India, CDSCO. We work tirelessly to ensure that our clients' products obtain successful registrations, making it possible to market their products in India. Let Regulatory Solutions India guide you through the regulatory process and help you unlock the potential of the Indian market.

FAQ’s

1. Do I need a warehouse/distributor license to sell medical supplies in India?

Yes, After the implementation of medical device rule 2022, any person or individual who wishes to sell, stock, exhibit, offer for sale, or distribute a medical device, including an in-vitro diagnostic medical device, will require a registration certificate in Form 42 (i.e. wholesale/distributor license) from the respective state licensing authority.

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2. What is form 41?

The application form to be filled out by the applicant and submitted to the State Licensing Authority (SLA) for the grant of a registration certificate to sell, stock, exhibit, or offer for sale or distribution.

3. What is form 42?

After the successful submission of the application in Form 41, the SLA will review your application and, if found satisfactory, will issue a registration certificate in Form 42.

4. What is form 43?

Form 43 is an inspection book that must be maintained by the applicant for the medical device officer to record their observations and findings.

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