Medical Device Import License by CDSCO: How to Get Form MD 15
The Indian healthcare industry has experienced significant growth in recent years, with a market size of $190 billion in 2020. According to projections by the India Brand Equity Foundation, this industry is expected to reach $370 billion by 2024-2025. The driving force behind this growth is the increasing demand for specialized and high-quality healthcare services. Various factors contribute to this expansion, including hospitals, medical devices, clinical trials, telemedicine, medical tourism, health insurance, and medical equipment.
Licensing Authority for Import License MD 15
The Central Drugs Standard Control Organization (CDSCO) is the licensing authority for Medical Device Import License MD 15 in India. All importers of medical devices and in-vitro diagnostic devices must obtain an MD 15 License to Import Medical Devices from the CDSCO before importing into India.
Overview of Medical Device Import License by CDSCO - MD 15 License
The Indian medical device industry heavily relies on imports to meet its demand for a wide range of healthcare devices. While India has a growing domestic manufacturing sector, it is still largely dependent on imported medical devices to fulfil the requirements of its healthcare system.
To import medical devices, including in-vitro diagnostic devices, into India, it is mandatory for the importer to obtain a medical device import license (MD 15 License) from the Central Drugs Standard Control Organization (CDSCO). This requirement is outlined in the Medical Device Rules of 2017, which govern the import, manufacturing, distribution, and sale of medical devices in India.
The Central Drugs Standard Control Organization (CDSCO) plays a crucial role in ensuring the safety and quality of medical devices imported into India. As part of its regulatory oversight, the CDSCO issues medical device import licenses to authorized agents who comply with the established rules and regulations.
CDSCO grants licenses through a structured process involving evaluation, inspection, and strict criteria adherence. Their aim is to safeguard public health and ensure the entry of safe and effective medical devices into India.
Let’s delve deeper into the key aspects and procedures involved in obtaining a medical device import license through the CDSCO.
MD 15 License to Import Medical Devices & IVDs: Get Expert Guidance from MedDev Experts
MedDev Experts, a leading medical device consulting company in India, provides complete guide, procedures, requirements, and regulations for MD 15 License to Import Medical Devices & In-Vitro Diagnostic Devices.
What is form MD 14?
Form MD 14 is known as the CDSCO application form to import medical devices into India. When a foreign manufacturer seeks to export medical devices to India, the application must be submitted through an authorized Indian agent or distributor. This representative must possess a valid wholesale license (MD 42) that allows the sale of medical devices in India.
What is MD 15 License?
The MD 15 license is granted to import medical devices into India issued by the CDSCO. The MD 15 license is a mandatory requirement for importing any medical device into India. MD 15 License is the gateway to import and sale medical devices and in-vitro medical devices in India.
How to Sell Medical Devices in India as a Foreign Manufacturer
To sell medical devices in India as a foreign manufacturer, you must:
- Appoint an authorized agent in India.
- Obtain an MD 15 license from the Central Drugs Standard Control Organization (CDSCO).
Your authorized agent will act as a liaison between you and the CDSCO and will assist you with the MD 15 license application process.
Who Can Apply for an MD 15 License to Import Medical Devices in India?
Any Indian business entity authorized by the actual foreign manufacturer and having a license to manufacture for sale or distribution (MD 5 or MD 9) or wholesale license (MD 42) for sale or distribution of medical devices can apply for an MD 15 License.
Importers and Wholesalers: Get an MD 15 License to Import Medical Devices in India
As an importer or wholesaler of medical devices and in-vitro diagnostic devices in India, you must obtain an MD 15 License prior to importing the devices into the country. This license is issued by the CDSCO to ensure the safety and quality of medical devices imported and sold in India.
Once you have obtained an MD 15 License, you will be able to import medical devices and in-vitro diagnostic devices into India and sell them under your trade name or manufacturer’s trade name.
Foreign Manufacturers: Get an MD 15 License to Sell Medical Devices in India
As a foreign manufacturer of medical devices, you must obtain an MD 15 License from the CDSCO before you can sell your products in the Indian market. To apply for an MD 15 License, you must appoint an authorized agent in India.
Your authorized agent will act as a liaison between you and the CDSCO and will assist you with the license application process. Once you have obtained an MD 15 License, you will be able to sell your medical devices in India through your authorized agent.
Hospitals and Healthcare Providers: Get an MD 15 License to Import Medical Devices
If you need to import specialized medical devices, testing devices, or custom-made devices for your patients, you must obtain an MD 15 License from the CDSCO.
Once you have obtained an MD 15 License, you will be able to import medical devices, testing devices, or custom-made devices for your patients.
Research Institutions: Get an MD 15 License to Import Medical Devices for Testing and Evaluation
If you are a research institution in India, you must obtain an MD 15 License from the CDSCO before you can import medical devices for clinical research or trials, essential equipment, or investigational medical devices for testing or evaluation.
Once you have obtained an MD 15 License, you will be able to import medical devices for clinical research or trials, essential equipment, or investigational medical devices for testing or evaluation.
MedDev Experts is a leading provider of authorized agent services in India for medical device manufacturers. We can help you to register your products with the CDSCO and start selling in the Indian market.
As your authorized agent, we will:
- Represent you in all dealings with the CDSCO
- Manage the import and distribution of your devices in India
- Ensure compliance with all Indian medical device regulations
We have a team of experienced professionals who can help you to navigate the complex regulatory landscape in India. We can also provide you with guidance on market access and marketing strategies.
Contact us today to learn more about our authorized agent services and how we can help you to bring your medical devices to the Indian market.
Deadline to Get MD 15 License to Import Medical Devices into India
October 1, 2023 is the deadline for all importers of medical devices to obtain an MD 15 License from the CDSCO. After this date, no medical devices will be allowed to be imported into India without a valid MD 15 License.
MedDev Experts is a leading medical device consulting firm that can help you with the MD 15 License application process. We have a team of experienced professionals who are experts in the MD 15 License requirements and can help you to ensure that your application is complete and accurate.
Contact us today for a free consultation to learn more about how we can help you get your MD 15 License.
How to apply online for MD 15 Import License?
Step 1: Applicant Registration
To apply for a medical device import license, you must register on the official CDSCO portal. It is important to ensure that your documents are in order to avoid rejection during the registration process. If your documents meet the requirements, your registration will be approved.
Step 2: Classification of your Device
Before applying for medical device import license, it is important to classify your device appropriately. The Central Drugs Standard Control Organization (CDSCO) periodically categorize medical devices based on their level of risk. To determine the accurate classification for your device, it is advisable to go through the classification notification issued by CDSCO.
By adhering to these guidelines, you can ensure that your device is classified correctly in accordance with the applicable regulations.
Step 3: Submit the Application
Once you have classified your devices, the next step is to apply the medical device import license online on the CDSCO SUGAM portal. During the application process, it is crucial to upload all the required documents accurately. These documents include information such as product details, manufacturing processes, quality certifications, and any other relevant information that demonstrates the safety and effectiveness of the devices.
After submitting all the required documents, you have to make the prescribed fee online through the Bharatkosh portal. To finalize your application, it is necessary to upload the digitally signed Form MD-14.
Once you have completed all the necessary steps and submitted your application to CDSCO, you will receive an application number. This number serves as a reference point for tracking the progress of your application and facilitates communication with CDSCO regarding any further requirements or inquiries.
To apply for a medical device import license, you must register on the official CDSCO portal at https://cdscomdonline.gov.in/. It is important to ensure that your documents are in order to avoid rejection during the registration process. If your documents meet the requirements, your registration will be approved.
Step 4: Assessment by CDSCO
After submitting your application for a medical device import license to CDSCO, they will assess your application for compliance with the applicable regulations. During this assessment, if CDSCO identifies any areas of non-compliance or requires further clarification, they may raise a query regarding your application.
Upon receiving a query, it is essential to promptly address and provide a satisfactory response to CDSCO. This may involve providing additional documentation, clarification, or any other information they request. Addressing the query in a timely and comprehensive manner is crucial to ensure a smooth evaluation process.
Step 5: Approval of License
Once CDSCO verifies the information provided and is satisfied with your response to the query, they will proceed with granting the import license. The grant of the import license is typically issued in the form of Form 15, which officially authorizes you to import the medical devices specified in your application.
Documents required to get medical device import license
To obtain a medical device import license, you need to upload the required documents on the CDSCO Portal.
- Power of Attorney authenticated in India either by a Magistrate of First Class or by the Indian Embassy in the country of origin or by an equivalent authority through apostille along with undertaking from the authorized agent.
- Self-attested copy of valid manufacturing license.
- Duly apostilled/notarized copy of Free Sale Certificate, Marketing Authorization of the product from National Regulatory Authority of country of origin.
- Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years.
- Notarized copy of ISO 13485 Certificate of Actual Manufacturer
- Notarized Full Quality Assurance Certificate/CE type examination Certificate/CE product quality assurance.
- Notarized CE design Certificate
- Notarized Declaration of conformity
- Notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority
- Constitution details of domestic authorized agent
- Plant Master file from the Manufacturer
- Device Master file from the Manufacturer.
The device master file should include the following key points for a comprehensive documentation:
- Executive Summary of the Device
- Reference to predicate or previous generations of the device
- Label & Instructions for Use
- Device Design and Manufacturing process with flow chart
- Essential Principles Checklist
- Risk analysis and control summary
- Design Verification and validation of the medical device
- Biocompatibility validation data
- Medicinal substances data if the device contains Drug
- Biological Safety (TSE/BSE)
- Sterilization Validation data, if the device is supplied in a sterile state
- Software verification and validation, if the device incorporates any software
- Animal studies Preclinical data
- Stability validation data
- Clinical evidence
- Post Marketing Surveillance data
- Batch Release Certificates or Certificate of Analysis of finished product for minimum 3 consecutive batches.
Fee for Medical Device Import License
Medical Device Classification in India: Everything You Need to Know
In India, all medical devices and in-vitro diagnostic devices are classified into four categories:
- Class A: Low risk
- Class B: Low moderate risk
- Class C: Moderate high risk
- Class D: High risk
Medical devices are classified according to the Medical Device Rules of 2017. The classification process is primarily determined by factors related to device risk, intended purpose, invasiveness, usage duration, and potential for harm. It is important to classify your devices properly prior to applying for an MD 15 license to import medical devices.
Class A Devices:
Class A devices are low risk devices with low complexity and minimal potential harm. Examples of Class A devices include bandages and surgical masks.
Class B Devices:
Class B devices are low-moderate risk devices with moderate complexity and have greater potential for harm if not used properly. Examples of Class B devices include syringes, dental cement, pregnancy detection kits, and nebulizers.
Class C Devices:
Class C devices are moderate-high risk devices with higher complexity and higher potential for harm if not used correctly or if any malfunctions occur. Examples of Class C devices include implantable devices, surgical lasers, and cardiac pacemakers.
Class D Devices:
Class D devices are highly complex and invasive devices with significant potential for harm if not used appropriately. Examples of Class D devices include heart valves, advanced surgical instruments, and life-supporting devices.
How to Classify Your Medical Devices
To classify your medical devices, you can refer to the List of Notified Medical Devices published by the CDSCO on their website. This list contains a comprehensive list of medical devices and their corresponding classification. You can download the list from our Download Section.
If you are unsure about the classification of your medical devices, you can contact MedDev Experts.
Validity of Import License
A license will remain valid indefinitely unless it is canceled or surrendered. To maintain the license’s validity, the licensee must deposit the license retention fee with the Central Licensing Authority every five years from the date of issuance.
If the fee is not deposited within the stipulated period, the license will be considered canceled. However, the Central Licensing Authority may allow the fee to be deposited with a late fee of two percent per month within 90 days after the due date.
How MedDev Experts will help you to get Medical Device Import License?
MedDev Experts, a trusted name in medical device regulatory consulting, offers comprehensive assistance for importers seeking medical device import licenses in India. With in-depth expertise, we guide clients through the process of obtaining licenses required to import medical devices into India.
Our services include classification, document preparation, CDSCO fee payment guidance, and resolution of queries. With a successful track record of 200+ CDSCO registrations and a global presence in 25 countries, MedDev Experts ensure a smooth and compliant import process for medical devices into India.
10 Essential Tips for Obtaining an MD 15 Import License for Medical Devices in India
Getting an MD 15 import license for medical devices in India can be a complex process, but it is essential for foreign manufacturers who want to sell their products in the Indian market. Here are 10 essential tips to help you get started:
- Appoint an Indian agent who has an MD 42 license to sell and distribute medical devices in India. Your authorized agent will act as your representative in all dealings with the CDSCO and will help you to navigate the regulatory landscape.
- Get the Power of Attorney legalized from the Indian Embassy in the manufacturer’s country. This document will give your authorized agent the legal authority to act on your behalf in India.
- Prepare the Power of Attorney in accordance with the Medical Device Rules, 2017. This document must be carefully drafted to ensure that it complies with all applicable regulations.
- Prepare the Device Master File as prescribed in the Medical Device Rules, 2017. This document contains detailed information about your medical device, including its design, manufacturing process, and quality control procedures.
- Prepare the Site Master File as prescribed by the CDSCO. This document contains detailed information about your manufacturing facility, including its equipment, personnel, and quality control system.
- Submit a notarized copy of the free sale certificate and manufacturing license. These documents are required to prove that your medical device is approved for sale and manufacture in the origin country.
- Submit the properly identified predicate device details to the licensing authority. A predicate device is a similar medical device that has already been approved for sale in India. By identifying a predicate device, you can streamline the approval process for your own medical device.
- Submit biocompatibility or evaluation report as applicable, or justification in the absence of these reports. These reports are required to prove that your medical device is safe for use.
- Get a free sale certificate from Australia, Canada, Japan, European Union Countries, or the United States of America in case of Class C or Class D devices. Class C and Class D devices are considered to be high-risk devices and require additional documentation for approval.
- Take guidance from regulatory experts like MedDev Experts prior to submission of the import license. Regulatory experts can help you to ensure that your application is complete and accurate, and that you have met all of the applicable requirements.
Once you have obtained an MD 15 License, you will be able to import medical devices and in-vitro diagnostic devices into India and sell them under your trade name or manufacturer’s trade name.
By following these tips, you can increase your chances of success in obtaining an MD 15 import license for medical devices in India.
Staying compliant within India’s medical device industry requires timely renewal of your MD 15 License. This crucial step safeguards your ability to manufacture and distribute medical devices legally. To avoid potential penalties or license revocation, let’s delve into the key deadlines, fees, and steps involved in the renewal process.
- Recommit to Compliance Every 5 Years: Your MD 15 License undergoes revalidation every 5 years to ensure alignment with updated regulations and industry standards.
- Grace Period for Timely Action: Should you inadvertently miss the renewal deadline, a 90-day extension is available to rectify the situation. However, a 2% monthly late fee applies to incentivize adherence to timelines.
- Avoid Automatic License Termination: Prompt payment within the 90-day window is crucial. Delaying payment beyond this grace period results in automatic license revocation, necessitating a new application process to resume operations.
Uninterrupted manufacturing and regulatory compliance go hand-in-hand. Renewing your MD 15 License ensures smooth operations and avoids potential hiccups. This step-by-step guide empowers you to navigate the process online confidently.
- SUGAM Portal: Head to SUGAM, the central online hub for medical device licensing in India.
- Renew, not New: Under “Renewal Application,” select “MD 15 License Retention.”
- Follow the Flow: The SUGAM portal will guide you through the required steps, including fee payment and document submission.
Remember, timely renewal keeps your business running smoothly and avoids unnecessary hassles. Take charge today and enjoy peace of mind knowing your MD 15 License is up-to-date!
To renew the MD 15 License, the applicant should provide the following documents:
1. Covering Letter
Just write a quick letter to the licensing authority explaining you’re requesting retention of your MD 15 License. Be sure to list all the devices covered and mention the fee payment details.
2. Base MD 15 License
You need to submit the copy of your MD 15 license for which retention is applied.
3. Undertaking
To renew your MD 15 License, just submit a signed statement from the actual manufacturer stating that:
- There is no change in the Plant Master File & Device Master File.
- Both the Manufacturer and the Indian Authorized Agent stating are agreed for further retention of the Import License MD 15.
- There is no change in the Power of Attorney (POA). If there is any change in the POA, submit the revised copy of POA.
- There is no change in the Certificate of Incorporation.
- You will submit the requisite fees for all the devices endorsed in the base license before completion of the five years from the date of issue of the base license.
4. Post Marketing Surveillance data
To keep your MD 15 License valid, tell the story of your commitment to safe devices. Just include the following in your renewal:
- Sales Data: Share the past 5 years of your medical device sales in India– transparency builds trust!
- Customer Complaint: List any complaints received in the last 5 years – showing you address customer complaint is key.
- Responsible Recalls: If you ever had to recall a product, briefly explain why and what you did to improve. It demonstrates proactive care.
- Continuous Improvement: Did you implement any corrective and preventive actions (CAPA) for any concerns? Share them – it showcases your dedication to quality.
5. Post Approval Change Applications (If Any)
Did you modify your medical device after getting your MD 15 License? No worries! Just include details of any “post-approval changes” you made, like new features or adjustments. It helps keep everything up-to-date and your license secure.
6. Fee for MD 15 License Renewal
Pay the fee for the renewal of MD 15 license and submit the payment deposit slip. Include the late fee (if any).
Upload the valid Free Sale Certificate/Marketing Authorization of the product from National Regulatory Authority of country of origin (if any) and Free Sale Certificate/Marketing Authorization of the product from National Regulatory Authority of any of the following countries viz USA, EU, UK, Canada, Japan, Australia.
8. Reason for Exclusion of any Devices from Renewal
If you want to exclude any device from renewal, you need to provide the reason thereof.
You need to provide the valid ISO 13485 certificate copy of the actual manufacturer.
You need to provide the valid CE Certificate copy of the actual manufacturer.
Frequently Asked Question on Medical Device Import License - MD 15 License
What is the medical device import license?
The medical device import license is a regulatory authorization granted by the Central Drugs Standard Control Organization (CDSCO) to allow the importation of medical devices into India.
What is form MD-14?
Form MD-14 is known as the CDSCO application form to import medical devices into India. When a foreign manufacturer seeks to export medical devices to India, the application must be submitted through an authorized Indian agent or distributor. This representative must possess a valid wholesale license (Form MD-42) that allows the sale of medical devices in India.
What is MD-15 License?
The MD-15 license is issued by the CDSCO to import medical devices and in-vitro medical diagnostic medical devices into India . The MD-15 license is a mandatory requirement for importing any medical device into India.
In which Form the application shall be made for import license?
The importer should apply for the Medical Device Import license in form MD-14 and the permission will be granted on MD-15.
Who requires a medical device import license in India?
Any individual or organization that intends to import medical devices into India for commercial purposes generally requires a medical device import license.
How do I apply for a medical device import license in India?
The application process for a medical device import license involves submitting the necessary documents and information through the CDSCO online portal.
How long does it take to obtain a medical device import license in India?
The processing time for a medical device import license can vary, but it typically takes 3 to 6 months. The timeline depends on factors such as the completeness of the application, the complexity of the device, and the workload of the regulatory authorities.
Are there any specific regulations or guidelines to comply with for importing medical devices into India?
Yes, medical device importers in India need to comply with the Medical Device Rules of 2017. The regulations cover aspects such as device classification, labeling requirements, quality management systems, and post-market surveillance.
Can I import medical devices without a license?
No, you cannot import a medical device into India without the import license.
MedDev Experts Provides Consultancy Services to Get Medical Device Import license Across Multiple Cities in India
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