logo
. . .

License to Import of Medical Devices - MD-15

Discover the comprehensive guide to obtaining an MD-15 license for importing medical devices in India. Explore device classification, regulatory requirements, and documentation needed to navigate the process smoothly. Form MD 14 & MD 15

0

Satisfied Customers

0

Global Business Setups

0

Professionals (CA,CS, Lawyers)

0

Offices

[ Rated 4.9 Stars By 7863+ Customers Globally]
Slider One

Permission to Import Medical Devices in India

The regulatory mechanism in India is made up of a variety of primary stakeholders in the fields of biotechnology, biomedical sciences, forestry, health care, animal science and the environment. The Indian drug regulatory system is therefore divided into central (federal) and state (provincial) authorities.

In recent times, India has emerged as the world's leading manufacturer of medical products. The medical device industry is a multi-product sector, manufacturing a wide variety of products. India's medical sector is rising as a key market for medical devices and diagnostics. These medical devices have not been controlled at an early stage, but according to the amended Drugs & Cosmetics Act, 1940, in 2006, the Central Drugs Quality Control Organization (CDSCO) clarified that medical products must be controlled under the Medical Device Regulations, 2017. CDSCO will also control the import, manufacture, distribution and selling of medical devices.

The goal of CDSCO is to safeguard and improve public health by ensuring the safety, effectiveness and efficiency of medicines, cosmetics and medical devices. CDSCO also regulates the standard of imported medical devices in port offices by the Central Licensing Authority and the State Licensing Authority. Although there is a limited list of regulated products, CDSCO periodically adds new items to the lists as well as changes to the regulatory framework in India. This article provides a summary of India's current regulatory system.

The new regulatory framework published by the Central Drugs Standard Control Organization (CDSCO) has developed new guidance documents or legal documents for the registration and re-registration of notified medical devices. Those legal guidelines were drawn up on the basis of the 2017 regulations on medical devices, which legally came into force on 11 January 2018. CDSCO is authorised for approving the application for permission to import medical devices in India, Import, Distribution And Registration Of Medical Devices In India.

In India there is a specific permission required to be obtained from the CDSCO for the import of medical device in India:

1. In Vitro Diagnostic Test Kits or medical test kits or In Vitro diagnostic Devices (This includes importing Covid Test kits like RT-PCR, Rapid Test Kits, Antigen Kits and Antibody Kits. This also includes HIV, HBsAg and HCV)

2. Disposable Hypodermic Syringes

3. Disposable Hypodermic Needles

4. Disposable Perfusion Sets

5. Cardiac Stents

6. Drug Eluting Stents

7. Catheters

8. Intra Ocular Lenses

9. I.V. Cannulae

10. Bone Cements

11. Heart Valves

12. Scalp Vein Set

13. Orthopedic Implants

14. Internal Prosthetic Replacements

15. Ablation Devices

Who needs to apply for permission to import medical devices?

Chapter 5 of the 2017 Medical Rules applies to the Legislation on the Manufacture of Medical Devices for Sale and Distribution in India. Any approved agent who already holds a license to manufacture medical devices for sale or distribution can apply for an import license. In addition, any wholesaler who wishes to import medical devices for sale and transfer shall also apply for an import license.

An importer of Rapid test kits for Corona Virus or Covid-19 strain will need to apply for permission for import of such kits. Any foreign manufacturer willing to supply test kits for corona virus in India will need to avail this permission for import in MD 15.

The licensing process is governed by the Ministry of Health and Family Welfare of the Central Government. The Ministry has an electronic portal from which an application for an import license has to be made. The application shall be made to the Central Licensing Authority using Form MD-14.

The applicant is also expected to request a number of additional documents along with the verification application form. First and foremost, the application must have a cover letter in the appropriate format and contain the correct information for the submission. We at Corpzo help our clients design an immaculate cover letter for their submission.

In addition, the applicant must apply a valid wholesale / manufacturer license for the Indian medical device agent. This is an essential prerequisite for the submission of an application. The applicant must also apply a Free Sales Certificate (FSC) with the submission. A Free Selling Certificate (FSC) is a document that means that the medical devices being imported are freely available on the open market in the exporting country and are licensed for export and trade liberalization.


1. Importing Companies:

a. Launching new medical devices: Importing companies must obtain permission when they plan to introduce new medical devices to the Indian market, especially when these devices have not been previously approved by the CDSCO. b. Importing updated or modified devices: If the importing company is dealing with an updated or modified version of a previously approved medical device, it must seek permission to ensure that the changes comply with the existing regulations and guidelines. c. Importing devices under new regulations: If there are changes to the existing regulations, importing companies may need to apply for permission to import medical devices that are now subject to the updated guidelines.

2. Medical Device Manufacturers:

a. Entering the Indian market: Foreign medical device manufacturers looking to introduce their products to the Indian market must apply for permission to import, ensuring that their devices comply with Indian regulations. b. Devices for clinical trials: If manufacturers need to import their devices for clinical trials or investigational purposes in India, they must apply for permission to do so.

3. Healthcare Providers:

a. Importing specialized equipment: Healthcare providers may need to import specialized medical devices or equipment that are not readily available in India, requiring them to apply for permission. b. Replacing outdated equipment: If healthcare providers intend to replace outdated equipment with imported devices, they must apply for permission to import the new devices. c. Expansion or renovation: Healthcare facilities undergoing expansion or renovation may require additional medical devices, necessitating permission to import.

4. Research Institutions:

a. Devices for clinical research: When research institutions require medical devices for clinical research or trials, they must apply for permission to import the necessary equipment. b. Investigational devices: If a research institution needs to import investigational medical devices for testing or evaluation purposes, it must apply for permission.

5. Non-Governmental Organizations (NGOs):

a. Humanitarian aid: NGOs involved in humanitarian aid or disaster relief efforts may require medical devices that are not readily available in India, necessitating permission to import the equipment. b. Healthcare initiatives: If an NGO is planning a healthcare initiative that involves the use of medical devices, it must apply for permission to import the required devices, ensuring they comply with the necessary safety and quality standards.

In each of these instances, the entities must obtain the necessary permissions and licenses, such as the MD-15 License, from the CDSCO to ensure that the imported medical devices meet the required safety and quality standards for their intended use.

Step wise process for Obtaining MD-15 License

Part 1: Process to Obtain License to Import Medical Devices (MD-15 License)

1. Collation of Documents:

Before initiating the application process, gather all the necessary documents required for the MD-15 License. Some of the essential documents include:

  • Legal documentation of the importing firm or individual (e.g., Certificate of Incorporation, Partnership Deed, or Proprietorship Proof).
  • Import Export Code (IEC) issued by the Directorate General of Foreign Trade (DGFT).
  • Authorization letter from the foreign manufacturer or their authorized representative.
  • Registration Certificate or Marketing Authorization issued by the regulatory authority in the country of origin.
  • ISO Certificate or other relevant quality certifications.
  • Product-specific technical documents, including device description, specifications, and labeling information.

2. SUGAM Portal Registration:

Register on the CDSCO's online portal, the SUGAM system (https://cdscoonline.gov.in), to initiate the application process. Create a user account and complete the registration process as per the guidelines provided on the portal.

3. Application Submission:

Log in to the SUGAM portal and submit the completed Form MD-15, along with the required documentation mentioned in step 1. Ensure that all the information provided is accurate and complete to avoid any delays or issues during the review process.

4. Application Review and Queries:

The CDSCO will review the application and may raise queries or request additional information if necessary. Respond to these queries promptly and provide any additional documentation requested to ensure a smooth review process.

5. Fees Payment:

Pay the applicable fees for the MD-15 License as specified by the CDSCO. The fees can be paid online through the SUGAM portal using the available payment methods.

6. Inspection and Audit:

The CDSCO may conduct an inspection or audit of the importing firm's facilities and processes to verify compliance with the established quality standards and guidelines. Ensure that your facility is prepared for this inspection, and address any issues or concerns raised by the auditors.

7. Approval and Issuance of MD-15 License:

Once the CDSCO is satisfied with the application, documentation, and inspection results, they will approve the MD-15 License. The license will be issued and made available for download through the SUGAM portal. The MD-15 License is generally valid for three years from the date of issue and may be renewed thereafter.


Part 2: Process to Import Medical Devices

8. Importation and Compliance:

With the MD-15 License in hand, you can now import the approved medical devices into India. Ensure ongoing compliance with the CDSCO's regulations and guidelines and maintain proper documentation to support any future audits or inspections.

By following this step-wise process, you can successfully obtain the MD-15 License to import medical devices into India. Ensure that you maintain compliance with the CDSCO's regulations and guidelines throughout the importation process to contribute to the safety and well-being of the public and the healthcare industry.

9. Customs Clearance:

Once the medical devices have arrived at the port of entry in India, you will need to clear them through customs. Prepare and submit the necessary documents, including the MD-15 License, Invoice, Packing List, Bill of Lading or Airway Bill, and any other required documents specified by the customs authorities. The customs officials may inspect the consignment to verify compliance with the applicable regulations and guidelines.

10. Import Duty and Taxes:

Pay the applicable import duties and taxes on the medical devices, as determined by the customs authorities. The duty and tax rates may vary depending on the type of medical device, its value, and the country of origin. It is essential to factor in these costs when importing medical devices.

11. Warehousing and Storage:

Once the medical devices have cleared customs, arrange for their transportation to a suitable warehousing or storage facility. Ensure that the facility meets the required storage conditions and standards for the medical devices, such as temperature, humidity, and cleanliness, to maintain their quality and effectiveness.

12. Distribution and Marketing:

With the medical devices safely stored, you can begin the process of distributing and marketing them within India. Develop a distribution network, including wholesalers, retailers, and healthcare facilities, and create marketing materials to promote the devices to the target audience. Ensure that all promotional materials are compliant with the CDSCO's regulations and guidelines.

13. Post-Market Surveillance and Vigilance:

After the medical devices have been distributed and are in use, it is essential to monitor their performance and safety through post-market surveillance and vigilance activities. Collect and analyze data on the devices' performance, adverse events, and customer feedback to identify any potential safety issues or areas for improvement. If any issues are detected, promptly report them to the CDSCO and take appropriate action to address the concerns.

14. License Renewal and Maintenance:

The MD-15 License is typically valid for three years from the date of issue. To continue importing medical devices, you will need to apply for license renewal before the expiration date. Ensure that you maintain compliance with the CDSCO's regulations and guidelines throughout the importation process and keep proper documentation to support any future audits or inspections.

By following these steps, you can successfully import medical devices into India while ensuring compliance with the necessary regulations and guidelines. This process helps maintain the safety and well-being of the public and contributes to the integrity of the healthcare industry.

Classification of Medical Devices by CDSCO

Understanding medical device classification is crucial for businesses planning to import medical devices in India, as it determines the appropriate regulatory pathway and the level of scrutiny required during the MD-15 license application process. This in-depth guide focuses on the medical device classification system for obtaining the MD-15 license in India, overseen by the Central Drugs Standard Control Organization (CDSCO). By comprehending the classification system, businesses can ensure compliance with regulatory requirements and a seamless application process. 

Several factors influence the classification of medical devices, including the device's intended use, invasiveness, duration of use, and potential harm. Here are some key factors that may impact a device's classification:

  1. Intended Use: The device's intended purpose or medical indication can greatly influence its classification. Devices designed for diagnostic purposes may have different risk levels compared to those used for therapeutic purposes.

  2. Invasiveness: The degree to which a device invades the body affects its classification. Non-invasive devices generally pose lower risks, while invasive devices that penetrate the body, such as implants or surgical instruments, carry higher risks.

  3. Duration of Use: The length of time a device is intended to be used can impact its classification. Devices meant for short-term or temporary use may pose lower risks than those designed for long-term or permanent use.

  4. Potential Harm: The potential harm a device may cause to patients or users is a critical factor in classification. Devices with a higher likelihood of causing harm, such as implantable devices, may be subject to more stringent regulatory requirements.

  5. Technological Complexity: The complexity of a device, including its design and technological features, can influence its classification. Devices with complex technological features, such as software or advanced materials, may require a higher level of regulatory scrutiny.

 


Medical Device Classification in India

Medical devices in India are classified based on their associated risk levels. The CDSCO follows four primary classes for this classification: A, B, C, and D. Each class represents a different degree of risk, and understanding the classification is essential for complying with the regulatory requirements and ensuring a smooth application process for the MD-15 license.

 

 

CLASSIFICATION

EXAMPLES

RISK LEVEL

TYPE OF REGULATION

Class A

Thermometers, tongue depressors

Low

License not required but voluntarily applied to be licensed by State Licensing Authorities (SLA)

Class B

Hypodermic needles, suction equipment

Low Moderate

Approval by the SLAs

Class C

Lung ventilator, bone fixation

Moderate High

Approval by Central Licensing Authority (CLA)

Class D

Heart valves, implantable devices

High

Approval by Central Licensing Authority (CLA)

 

  1. Class A (Low Risk): Devices in this category pose minimal risk to patients or users. They are usually non-invasive and simple to use, with a low likelihood of causing harm. Examples of Class A medical devices include:

    • Surgical instruments: These are tools or devices used by healthcare professionals during surgical procedures, such as scalpels, forceps, and scissors.

    • Tongue depressors: These are simple devices used to hold down the tongue during a medical examination of the mouth and throat.

    • Bandages: These are materials used to wrap or cover a wound, providing support and protection to the injured area.

  2. Class B (Low-Moderate Risk): Devices in this category pose a low to moderate risk to patients or users. They are typically non-invasive or minimally invasive devices with limited potential for harm. Examples of Class B medical devices include:

    • Hypodermic needles: These are hollow needles used to inject medications, vaccines, or other substances into the body, or to withdraw fluids, such as blood samples.

    • Suction equipment: These devices are used to remove fluids, gases, or other substances from the body, typically during surgical procedures or medical examinations.

    • Hearing aids: These are electronic devices worn in or behind the ear, designed to amplify sound and help individuals with hearing loss.

  3. Class C (Moderate-High Risk): Devices in this category pose a moderate to high risk to patients or users. They are often invasive, life-sustaining, or life-supporting, and may require a higher level of scrutiny during the regulatory process. Examples of Class C medical devices include:

    • Lung ventilators: These are machines used to support or replace the function of the lungs, typically in patients who are unable to breathe on their own.

    • Bone fixation plates: These are metal plates used to hold broken bones in place, allowing them to heal properly.

    • Blood bags: These are containers used to collect, store, and transport blood or blood components for transfusions.

  4. Class D (High Risk): Devices in this category pose a high risk to patients or users and are typically life-sustaining or life-supporting. They are often implantable devices that remain in the body for extended periods and require the highest level of regulatory scrutiny. Examples of Class D medical devices include:

    • Implantable cardiac pacemakers: These are small electronic devices implanted in the chest to help regulate the heartbeat in patients with abnormal heart rhythms.

    • Heart valves: These are prosthetic devices used to replace damaged or diseased heart valves, allowing blood to flow properly through the heart.

    • Orthopedic implants: These are devices, such as artificial joints or bone plates, used to replace or support damaged or diseased

Documents Required for obtaining MD-15 (License to Import Medical Devices in India)

Applicant and Manufacturer Information:

  • Applicant's name, address, and contact details;
  • Foreign manufacturer's name, address, and manufacturing premises;
  • Copy of the Plant Master File;
  • Importer's name and address;
  • Local authorized representative's name and address;
  • Local manufacturer details, if any processing occurs within the country.

Product Details:

  • Brand or proprietary name of the device;
  • Device category;
  • Method of use and intended purpose;
  • Brief description of the device;
  • Overview of manufacturing techniques and materials used;
  • Device variations in style, size, or shape, if any;
  • Recommended storage conditions;
  • Warnings, contraindications, and precautions for potential adverse events;
  • Summary of any reported issues;
  • Quantitative and qualitative particulars of the components;
  • Device standards compliance and a copy of the standard;
  • List of accessories and other devices used in conjunction with the device;
  • Packaging description, including package sizes;
  • Labeling details in compliance with the Drugs & Cosmetics Rules, 1945;
  • Promotional literature and physician manual in English;
  • Medical specialty in which the device is used.

Regulatory Approvals and Certifications:

  • Product approvals from other regulatory agencies, including:
    • CE Certificate from the EU;
    • Approval from other countries;
    • US FDA Approval or Clearance;
    • Approval from Japan, Australia, or Canada;
  • List of countries where the device is currently being marketed;
  • EN or ISO Certification for the manufacturing facility, if available;
  • List of countries where the device was withdrawn from sale, if applicable.

Master File and Quality Assurance:

  • Device's shelf life;
  • Device Master File;
  • Functionality test protocol and report, if applicable;
  • Stability data or statement for materials used, as relevant;
  • Manufacturing process flowchart;
  • Risk assessment following ISO 14971;
  • Quality assurance procedures or process controls;
  • Sterilization process and verification or validation;
  • Device GMP Certificate;
  • Materials or components used;
  • Final product testing and design verification, if applicable;
  • Biocompatibility and toxicological data, if relevant.

Devices Incorporating Medicinal Products:

  • Clinical data and published articles, if available;
  • Clinical trial reports, sales details, and product complaint details for devices not authorized for marketing in the country, if applicable;
  • Data on the safety, quality, and usefulness of the medicinal substance, if the device incorporates a medicinal product with a secondary effect;
  • Batch Release Certificate for products with medicinal substances of animal origin;
  • Compatibility data for devices designed to deliver medicinal products.

Post-Market Surveillance:

  • Handling of complaints;
  • Procedures for record distribution;
  • Product recall process;
  • Adverse incident reporting.

Conformity Undertaking: Declaration concerning product standards, safety and efficacy requirements, and quality systems in the country of origin.

This list provides a comprehensive overview of the required documents and information for importing medical devices. Please note that specific requirements may vary depending on the device and the importing country's regulations. It is advisable to consult the relevant regulatory body for up-to-date information.

Timeline for Grant of Licence (MD-15)

The timeline for obtaining an import license for medical equipment in India can vary depending on various factors, such as the complexity of the device, the completeness of the submitted documentation, and the efficiency of the regulatory authorities. Generally, the process can take anywhere from 2 to 6 months, or even longer in some cases. However, here is a general outline of the process and estimated timeframes:

  1. Preparation of documentation: Gather all the necessary documentation and ensure that it meets the requirements of the regulatory body. This process can take several weeks to months, depending on the complexity of the device and the availability of the required information.

  2. Submission of application: Submit the application, along with the required documentation, to the appropriate regulatory authority. The time it takes to submit an application depends on the applicant's preparedness and the specific submission process.

  3. Review of application: The regulatory authority will review the application and may request additional information or clarification. This review process can take anywhere from a few weeks to several months, depending on the complexity of the device, the completeness of the application, and the workload of the regulatory body.

  4. Inspection: Some regulatory authorities may require an inspection of the manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP). The timeframe for scheduling and conducting the inspection depends on the availability of the inspectors and the manufacturer's readiness for inspection.

  5. Decision: Once the application review and, if applicable, the inspection are complete, the regulatory authority will make a decision on whether to grant the license. This decision-making process can take a few weeks to several months, depending on the specific regulatory authority and the complexity of the application.

  6. Issuance of the license: If the regulatory authority approves the application, they will issue the license, allowing the applicant to import the medical devices. The time it takes to issue the license can vary depending on the regulatory authority's processes.

In summary, the process of obtaining a license to import medical devices can take anywhere from a few months, depending on the specific circumstances. It is essential to plan ahead and ensure that all documentation is complete and accurate to minimize delays. Additionally, keep in mind that the timeline may vary depending on the specific regulatory authority and the device's classification.

 

Once you submit your application to the Central Drugs Standard Control Organization (CDSCO) along with the required documents, the CDSCO will review the application and assess the compliance of the medical equipment with the applicable regulations. This review process can take several weeks or months, depending on the workload of the CDSCO and the nature of the medical device.

If the CDSCO approves your application, they will issue an import license, which is generally valid for three years. However, it is essential to note that the timeline can vary depending on specific circumstances, and there could be delays due to regulatory backlogs or other unforeseen issues.

To expedite the process, it is crucial to ensure that your application is complete, accurate, and supported by all the necessary documents. Working with an experienced consultant or advisory firm can help you navigate the process more efficiently and ensure compliance with all regulatory requirements.

 

Procedure for getting Permission to Import In-Vitro Diagnostic Test Kits (Covid Test Kits)

For the importation of Class A, B, C & D In Vitro Diagnostic Kits, the applicant (foreign manufacturers) must apply the documentation as set out in Part I, Part II and Part III of the Fourth Schedule (Appendix I & III only), along with the fee specified in the second Schedule of the new medical device rules.

An approved agent holding a manufacturing or wholesale license for sale and distribution issued pursuant to MDR 2017 may, on behalf of the distributor, apply to the Authority for an import license for IVD in Form MD-14. The license will then be obtained in the form MD-15.

The licensing process is governed by the Ministry of Health and Family Welfare of the Central Government. The Central Drugs Standard Control Organization (CDSCO) has created a separate online safety platform for the Pre-Registration of Applicants prior to filing for registration of their expected Vitro Diagnostic Kits in India.

The CDSCO Online Licensing Portal was launched on 14 November 2015 and was called "SUGAM." It is a secure, fast and spam-free portal launched by the Ministry of Health and Family Welfare. Our team of experienced professionals will be pleased to represent you on Sugam Registration. 

Why CorpZo?

Navigating the complex process of obtaining an import license for medical equipment in India can be a daunting task. With Corpzo by your side, you can rest assured that our team of experienced professionals will guide you every step of the way. Having successfully facilitated over 100 import licenses for our clients, we have the expertise and knowledge to help you achieve your goals in a smooth and hassle-free manner.

How Corpzo Can Help You:

  1. Expert Guidance: Our team of skilled professionals has in-depth knowledge of the regulatory requirements for medical equipment imports in India. We stay updated with the latest changes in regulations and provide you with accurate and reliable advice tailored to your specific needs.

  2. Comprehensive Support: Corpzo offers end-to-end support throughout the import license application process. From obtaining an Import Export Code (IEC) to registering with the CDSCO and submitting the license application, our team will assist you in every stage to ensure compliance with all requirements.

  3. Documentation Assistance: Preparing the necessary documents for your import license application can be time-consuming and challenging. Corpzo's experts will help you compile and review the required documents, ensuring that your application is complete and accurate.

  4. Expedited Processing: With our extensive experience and strong relationships with regulatory authorities, we can help expedite the processing of your import license application. Our team will closely monitor the progress of your application and communicate with the authorities to address any queries or concerns promptly.

  5. Post-License Support: Corpzo's commitment to your success extends beyond obtaining the import license. We provide ongoing support to ensure that you maintain compliance with all applicable regulations, including labeling and packaging requirements, and any post-market surveillance requirements as mandated by the CDSCO.

Choose Corpzo for a seamless and efficient medical equipment import license process. Our track record of facilitating over 150 licenses for our clients speaks to our expertise and dedication to helping businesses succeed in the medical equipment import industry. Contact us today at +91-9999139391 or reach@corpzo.com to learn more about our services and how we can help you achieve your business goals.

FAQ's for MD-15 (License to Import Medical Devices)

Q: How can I import Covid (In-Vitro Diagnostic Test Kits?

ANS: In order to import an type of medical device including In-Vitro Diagnostic Devices for covid (including RT-PCR kits, Rapid Test Kits, Antigen Test Kits and Antibody test kits)


Q: What is MD-15?

ANS: MD-15 is a permission to import Medical devices in India MD-15 is a permission to import any type of medical device (including In-Vitro Diagnostic Kits) in India. This License/permission is granted by CDSCO and is to be mandatory applied by a person who wishes to import medical equipment or In Vitro Diagnostic Devices.


Q: Who needs permission to import in MD 15?

ANS: Any person who wishes to import medical equipment or In Vitro Diagnostic Devices of any kind manufactured or supplied a person outside India needs a permission to do so.


Q: What is the governing body for grant of permission to import medical devices?

ANS: All medical devices are governed by the Indian Drug Controller General (DCGI) under the Central Drugs Standard Control Organization (CDSCO); part of the Ministry of Health and Family Welfare (MHFW).


Q: What is a Medical Device?

ANS: 'medical device' means,-(a) an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including software or accessories, intended by its manufacturer to be used specifically for humans or animals which do not have the primary intended effect on the human body or animals by any pharmacological or immunological or metabolic means;


Q: What are the categories of Medical Device defined under the Medical Device Rules?

ANS:

INTERNATIONAL CLASSIFICATION

EXAMPLES

RISK LEVEL

TYPE OF REGULATION

Class A

Thermometers, tongue depressors

Low

License not required but voluntarily applied to be licensed by State Licensing Authorities (SLA)

Class B

Hypodermic needles, suction equipment

Low Moderate

Approval by the SLAs

Class C

Lung ventilator, bone fixation

Moderate High

Approval by Central Licensing Authority (CLA)

Class D

Heart valves, implantable devices

High

 

 


Q: What is the Process of Approval?

PRE-MARKET APPROVAL PROCESS *

CLASS A

CLASS B

CLASS C

CLASS D

SELF-REGULATION

APPROVAL BY SLA

APPROVAL BY CLA

Application for registration (appoint an authorized Indian agent)

Registration certificate issued by CDSCO

Application for import license

Import License issued by CDSCO


Q: What is the validity if this licence?

ANS: New Medical Device rule published in October, 17, 2016. Device registration do not expire but keep paying the fee every 5 years.


Q: Do the Medical devices which have already been marketed in India before the start of these rules need this licence?

ANS: Medical devices which have already been marketed in India before the start of these rules shall continue to be marketed as before the expiry of 18 months or the current validity of the license from the beginning of these rules.

Such devices are known as Predicate: It is one of the most important things under the process of registration. Hence, it is a must to have a predicate device locally in India. Without a predicate device the process becomes tedious and time consuming. If a predicate is not available the application is to be filed vide MD-26 and registration is to be obtained in MD-27.


Q: Is there any additional licence required for this licence?

ANS: A license shall be granted if the medical device has a Free Sale Certificate (FSC) provided by the national regulatory authority or any other competent authority in any of the countries (Australia, Canada, Japan, the countries of the European Union or the United States of America).


Q: What are the types of licence for importing of medical devices required by foreign Companies/manufacturers in India?

ANS:

a) Manufacturing License of Medical Devices

For an application for a license to manufacture for distribution/sale of Class A & B devices, the application should be made online in Form MD- 3 or Form MD- 4 (for loan license) along with a fee. The license will be obtained under Form MD-5 or Form MD- 6 (for loan license).

For an application for manufacture for distribution/sale of Class C & D devices, the application should be made online in Form MD- 7 or Form MD-8 (for loan license) along with a fee. The license will be obtained under Form MD-9 or Form MD- 10 (for loan license).

b) Medical Devices

An application should be made online to the Central Licensing Authority (CLA) under Form MD- 14 for obtaining a license to import for sale or distribution via an authorized agent already possessing a license for manufacture for sale/distribution of medical devices or a wholesale license for sale/distribution of medical devices.

If the registration is compliant, the license will be issued under Form MD-15.


Q: What is an import license for medical equipment in India, and why do I need it?

A: An import license for medical equipment is a legal authorization granted by the Central Drugs Standard Control Organization (CDSCO) to import medical devices and equipment into India for sale, distribution, or use. You need this license to ensure compliance with the guidelines and regulations set forth by the CDSCO, which aim to protect public health and ensure the safety, efficacy, and quality of medical devices in the country.


Q: What are the different classifications of medical devices in India?

A: Medical devices in India are classified into four categories based on their risk level: Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), and Class D (high risk). The classification determines the specific regulatory requirements and approval process for each medical device.


Q: How long does it take to obtain an import license for medical equipment in India?

A: The timeline for obtaining an import license can vary depending on various factors, such as the complexity of the device, the completeness of the submitted documentation, and the efficiency of the regulatory authorities. Generally, the process can take anywhere from 2 to 6 months or even longer in some cases.


Q: What is the validity period of the import license for medical equipment?

A: The import license for medical equipment in India is generally valid for three years from the date of issue. After the license expires, you need to apply for a renewal to continue importing medical devices.


Q: Can I import medical equipment without an Import Export Code (IEC)?

A: No, an Import Export Code (IEC) is a mandatory requirement for every importer and exporter in India. You need to obtain an IEC from the Directorate General of Foreign Trade (DGFT) before applying for an import license.


Q: Are there any specific quality certifications required for importing medical equipment in India?

A: Yes, depending on the classification of the medical device, you may need specific quality certifications, such as ISO 13485 certification, CE marking, or US FDA approval. These certifications demonstrate that the medical equipment meets international quality and safety standards.


Q: Can I import medical equipment for personal use without an import license?

A: Importing medical equipment for personal use without an import license may be allowed in some cases, depending on the type and quantity of the equipment. However, it is essential to consult with the regulatory authorities or seek professional advice to understand the specific requirements and exemptions applicable to your situation.


Q: How can Corpzo help me in obtaining an import license for medical equipment in India?

A: Corpzo offers comprehensive support throughout the import license application process, including expert guidance, documentation assistance, expedited processing, and post-license support. Our team of experienced professionals will help you navigate the complex regulatory landscape and ensure compliance with all requirements, making the process seamless and hassle-free.


Q: Are there any penalties for non-compliance with the import regulations for medical equipment?

A: Yes, non-compliance with the import regulations for medical equipment in India can lead to penalties, including fines, suspension or revocation of the import license, and even criminal prosecution in severe cases. It is crucial to ensure compliance with all applicable regulations to avoid such consequences.


READ DETAILED FAQ'S

  • STAGE 1

    CONNECT WITH US

    We are just a call or message away!

    Call or WhatsApp us on +91-99991-39391 for free consultation from our team of experts. You can also email us on reach@corpzo.com.

  • STAGE 2

    PROCESS AND DOCUMENTATION

    Your consent is essential!

    We share the detailed and reasonable estimated costs, documents and prerequisites for the complete process before starting the process to ensure transparency.

  • STAGE 3

    SHARE YOUR DOCUMENTS

    We ensure timelines are met!

    Our team warrants hassle free documentation. We collect the necessary documents and share the relevant drafts to ensure a timely filing and delivery.

  • STAGE 4

    PROCESSING AND UPDATE

    Precision is our speciality!

    Upon collecting the necessary documents and information, we waste no time in preparation and filing of your application. development on your application is brought to your attention.

  • STAGE 5

    SUCCESSFUL COMPLETION

    We deliver what we commit!

    On successful completion of the case we share all the relevant documents electronically and physically along with an assurance to pay you back if something is wrong.

Request A Callback
Related Services

Expert Legal Advisory Our Customers Love

Bespoke advisory focused on mission critical legal, financial and business aspects.

server room

Trusted By Clients And Industry Experts

Uniquely repurpose strategic core competencies with progressive content. Assertively transition ethical imperatives and collaborative manufactured products.

Write About us
Let’s chat? - We're online
Corpzo Chat Now Corpzo Chat Image
Book An Appointent

Shabnam

From Mumbai Recently Purchased @Partnership Firm Registration