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ZYPS — TRUSTED REGULATORY PARTNER

MD 5 License

Class A & B · Medical Device Manufacturing India

Complete assistance from Form MD 3 application

to final MD 5 license approval from SLA.

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Form MD 3
Application
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SLA Approval
State Authority
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Factory Audit
Preparation
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Document
Filing Support
MDR 2017
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EXPERIENCE
5+ Years
MD 5 License Regulatory Consultant ZYPS India
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In India, the regulation of all medical devices and in-vitro diagnostic devices falls under the Medical Device Rule, 2017. These devices are categorized into four groups - A, B, C, and D - based on their associated risk levels. Any company intending to manufacture medical devices in India must obtain a medical device manufacturing license from the appropriate licensing authority.

For Class A and B devices, the State Licensing Authority is responsible for issuing manufacturing licenses. The Central Licensing Authority, CDSCO, handles licenses for Class C and D devices. To manufacture Class A and Class B devices, one must obtain the Medical Device Manufacturing License (Form MD 5) from the State Licensing Authority.

The application process for the MD 5 License to Manufacture Class A or B Medical Devices and IVDs involves submitting Form MD 3, and the license itself is granted under MD 5. Before applying for the MD 5 License, applicants must ensure compliance with the requirements outlined in the Medical Device Rule, 2017.

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At ZYPS Experts, we specialize in advising our clients on adhering to the regulations set forth in the Medical Device Rule, 2017, and obtaining the MD 5 License for manufacturing Class A or B Medical Devices and IVDs. Our team of seasoned regulatory experts provides comprehensive guidance every step of the way, starting from conducting gap analyses to completing the application process and securing the MD 5 License for manufacturing Medical Devices and IVDs.

How to Determine Your Device Classification?

Manufacturers are tasked with classifying devices according to the guidelines outlined in Chapter 2 of the Medical Device Rules, 2017, taking into account the risk associated with each device. Class A devices, characterized by simplicity, present the lowest risk and minimal potential for harm. In contrast, Class B devices carry a higher risk level, falling into the category of low to moderate risk, with greater potential for harm compared to Class A devices.

The CDSCO releases a compilation of notified devices along with their respective classifications on its website. You can access and download this list of notified devices from our designated download page.

What does MD 3 refer to in the context of medical devices?

Form MD 3 is the application form that manufacturers of Class A or Class B Devices must submit to the State Licensing Authority when applying for the MD 5 License to Manufacture Medical Devices and IVDs in India.

What does "MD 5" signify in the domain of medical devices?

Form MD 5 represents the license issued by the State Licensing Authority to manufacturers of Class A or Class B Devices, permitting them to produce and distribute medical devices, including in-vitro diagnostic devices, within India.

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Who can apply for MD 5 License?

Enterprises aiming to produce Class A or Class B medical devices and in-vitro diagnostic devices onsite are eligible to apply for the MD 5 License.

Why do you need an MD 5 License?

In order to lawfully produce Class A or Class B medical devices or in-vitro diagnostic devices in India, possession of an MD 5 License is required.

Documents required for MD 5 License?

As per the regulations outlined in the Medical Device Rules, 2017 and CDSCO guidelines, applicants must submit the following compulsory documents when applying for the MD-5 License.

  • Application Form (MD-3)
  • Site master file
  • Device master file
  • ISO 13485 Certificate
  • Receipt of the Fee
  • Company Identity
    • Partnership deed / Memorandum of Association
    • List of directors/partners
    • Sale deed/rent deed
  • Performance evaluation report (if IVDs)
  • Test License, if any

What is the process for applying to obtain the MD 5 License?

  • Step 1: Register Your Organization on CDSCO's SUGAM Portal: Complete user registration on the SUGAM Portal of CDSCO for your organization.

  • Step 2: Complete Application Form MD-3: Fill out the designated application form (MD-3) and submit it via CDSCO's online SUGAM Portal.

  • Step 3: Submit Documents and Make Payment: Upload essential documents such as the site master file, device master file, along with any other required paperwork, and proceed with the payment.

  • Step 4: Application Review by Licensing Authority: The State Licensing Authority will examine your application. If it meets the criteria, it will advance to a quality management system compliance audit.

  • Step 5: Audit Conducted by Notified Body: An accredited notified body endorsed by CDSCO will conduct an audit of your facilities. Should any Non-Conformance (NC) be identified, you will need to furnish an NC closure report.

  • Step 6: Issuance of MD-5 License: Upon fulfillment of all requirements, the state licensing authority will authorize the issuance of the license.

We've compiled an extensive guide on obtaining a Medical Device Manufacturing License in India. Our blog provides comprehensive information on the application process, along with a step-by-step walkthrough for applying for the license. Should you require any assistance with the application procedure, please don't hesitate to reach out to us. We're here to assist you every step of the way.

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Requirements for MD 5 License

It is necessary to:

  • 1. Present your license to the Medical Device Officer or another senior officer upon request.

  • 2. Notify the State or Central Licensing Authority of any significant adverse events and actions taken within a 15-day period.

  • 3. Obtain approval in advance from the State Licensing Authority for any significant alterations to your manufacturing process.

  • 4. Notify the State or Central Licensing Authority of any minor adjustments to your manufacturing process within a 30-day timeframe.

  • 5. Ensure that every batch of products undergoes testing before being approved for sale.

  • 6. In the event of non-conformance with the Act and rules, withdraw any batch of products and initiate a recall of any affected items already sold if directed by the State Licensing Authority.

  • 7. Maintain an audit or inspection log for the Notified Body or Medical Device Officer to document their observations and any instances of non-conformity.

  • 8. Retain a minimum of one unit sample from each batch of invasive medical devices and in vitro diagnostic medical devices manufactured for reference purposes for a period of 180 days following the batch expiry date.

  • 9. Maintain records of manufacturing and sales that are subject to inspection by a Medical Device Officer.

  • 10. If applicable, ensure that medical devices are accompanied by a package insert or user manual when they are offered for sale.

  • 11. Manufacture or conduct testing of medical devices solely under the guidance and supervision of competent technical personnel.

  • 12. Notify the State Licensing Authority in the event of cessation of manufacturing activities or closure of your manufacturing site for a period of 30 days or longer.

Adhering to these conditions ensures the validity of your MD5 license and confirms your operation's compliance with legal requirements.

Alteration in Organization structure

If your company undergoes a change in ownership or structure and holds a license for medical device manufacturing, it is imperative to inform the State Licensing Authority within 45 days. Additionally, you must apply for a new license within 180 days. Your existing license will remain valid until a new one is obtained or until your application is declined. In the event of application rejection, you have the option to appeal to the State Government within 60 days.


The State Licensing Authority performs surprise inspections at medical device manufacturing sites.

The State Licensing Authority has the authority to conduct unannounced inspections at medical device manufacturing sites. These inspections, overseen by a Medical Device Officer, occur randomly and are conducted at least 2% of the time.


Understanding the Process of Suspending and Canceling Medical Device Licenses

In case of rule violations by a medical device manufacturer, the government reserves the right to suspend or revoke their license. The manufacturer will be provided with an opportunity to present their case and justify why their license should not be suspended or revoked prior to a final decision being reached.

Should a manufacturer's license face suspension or cancellation, they have the option to appeal to the government within a 45-day period. The government will grant the manufacturer a hearing before rendering a decision. The government retains the authority to rescind a suspension order if deemed appropriate.

Prerequisites for Acquiring MD 5 License for Manufacturing Medical Devices and IVDs

To obtain the MD 5 Medical Device Manufacturing License, the manufacturing site's Quality Management System must be certified with ISO 13485 or ICMED 13485. Additionally, the manufacturer must appoint proficient technical personnel for both device manufacturing and testing purposes.


Fee associated with the MD 5 License

The fee is outlined in the Second Schedule of the Medical Device Rule, 2017. For the MD 5 License to Manufacture Class A or B Medical Devices and IVDs in India, the manufacturer is required to pay ₹5,000/- per site and ₹500/- for each distinct device.


Renewal and Duration of Validity for MD 5 License

Once issued, the license will remain valid indefinitely, contingent upon the applicant's payment of the retention fee every five years from the date of issuance.


Timeframe for Obtaining MD-5 License

Obtaining the MD-5 License from the state licensing authority typically requires a period of 3 to 6 months.


Who can assist with obtaining the MD-5 License?

ZYPS Experts, a regulatory consultancy with over 5+ years of experience, specializes in assisting companies in obtaining MD-5 Licenses.

Preparing for an Audit by the Notified Body for MD 5 License

Your manufacturing facility is scheduled for an audit by a Notified Body registered with the CDSCO to ensure compliance with the Medical Device Rules, 2017. This thorough audit encompasses critical areas including facility preparedness, quality management systems, device master files, risk management, validation, testing, and manufacturing procedures.

Obtaining your MD 5 License and entering the rapidly growing Indian medical device market is an attainable objective. While facing the Notified Body audit may appear intimidating, rest assured – we're here to equip you with the resources and expertise needed to overcome any challenges!


Below are five effective steps to guarantee a seamless and triumphant Notified Body audit:

1. Paperwork Perfection: Refine Your Documentation for a Flawless Audit

  • Conduct a comprehensive review of your quality management systems, quality manual, manufacturing procedures, product specifications, risk management plan, device master file, and site master file.

  • Ensure that your documentation is up-to-date, accurate, and adheres to the most recent MD 5 License stipulations. Avoid encountering inconsistencies or obsolete details.

  • Elevate your Quality Management System to align with global standards like ISO 13485 or ICMED 13485. Impress auditors with robust design control, risk management, and post-market surveillance procedures.


2. Prepare Your Facility: Transform Your Environment to Align with GMP Standards

  • Upgrade your manufacturing facility to comply with Good Manufacturing Practices (GMP), focusing on cleanliness, organization, and efficiency.

  • Resolve any non-compliance issues promptly.

  • Keep in mind that Notified Body auditors thoroughly scrutinize your surroundings, so ensure it is impeccably maintained!


3. Device Testing: Showcase the Superiority of Your Products

  • Subject your medical devices to rigorous testing and validation, ensuring conformity with designated standards, including biocompatibility, sterilization, and other relevant aspects.

  • Eliminate any doubt by conducting thorough testing, showcasing your unwavering commitment to quality and safety.


4. Mastering Risk Mitigation: Excelling in Preventing Incidents

  • Become proficient in risk management! Identify, evaluate, and preemptively address potential risks associated with your devices.

  • Thoroughly document your risk assessments and mitigation strategies to underscore your commitment to patient safety.


5. Team Empowerment: Foster a Group of Quality Champions

  • Invest in your team's skills! Offer training on the most recent regulatory mandates and guarantee proficiency in executing quality protocols.

  • A skilled and knowledgeable team not only impresses auditors but also ensures consistent quality.

By following these 5 impactful steps, you can transform your Notified Body audit from a daunting challenge into a victorious opportunity.

Feeling apprehensive about the upcoming Notified Body Audit?

ZYPS Experts provides comprehensive guidance throughout the audit process, ensuring adherence to the Medical Device Rules, 2017. Our experts evaluate facility preparedness, quality management systems, device master files, risk management, validation, testing, and manufacturing procedures.

Book a complimentary consultation today and discover how we can assist you in securing seamless MD 5 License approval.

Quality Management System ISO 13485 for MD-5 License

ISO 13485:2016 Medical Device Quality Management System is a mandatory requirement for all medical device and in-vitro diagnostic device manufacturers. It delineates the criteria for establishing a quality management system.

This system is vital for organizations aiming to showcase their proficiency in consistently providing medical devices and related services that not only meet customer expectations but also adhere to pertinent regulatory requirements.

These organizations may be involved in different phases of a product's lifecycle, including design and development, manufacturing, storage, distribution, installation, servicing of medical devices, as well as the design, development, or provision of complementary functions (e.g., technical support).

Moreover, ISO 13485:2016 can act as a valuable resource for suppliers and external entities offering products or services related to quality management systems to these organizations.

ZYPS Experts provides ISO 13485 Certification Services. Contact us now to get certified.

How ZYPS Experts can assist you in obtaining an MD 5 License

ZYPS Experts, a premier medical device consulting firm in India, offers services aimed at assisting companies in securing MD 5 Licenses. We provide a wide array of comprehensive services, including:

  • Submission of Application Form MD-3: We will assist you in completing and submitting Form MD-3, the application form for obtaining a Manufacturing License for Class A and B medical devices and in-vitro diagnostic devices.

  • Development of SOPs and Formats: We will provide guidance in creating thorough Standard Operating Procedures (SOPs) and documentation formats tailored to meet your Quality Management System (QMS) needs and regulatory standards.

  • QMS Certification: We will assist you in developing and implementing a resilient QMS customized to comply with ISO 13485 standards and offer ISO 13485 certification.

  • Mock Audit Readiness: Internally, we will perform a mock audit to pinpoint areas for enhancement and guarantee preparedness for the impending audit by Notified Bodies.

  • Notified Body Audit: We will facilitate and actively engage in the audit process led by the Notified Body, ensuring full compliance with all requirements.

  • SUGAM Portal Query Handling: We will assist you in preparing and submitting comprehensive responses to any queries raised by the licensing authority throughout the licensing process.

Are you in search of an MD-5 License to Manufacture Medical Devices & IVDs in India?

Reach out to ZYPS Experts today! Our team of seasoned professionals is equipped to guide you through the intricate regulatory procedures and facilitate the approval of your MD-5 license.

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What makes ZYPS Experts the ideal choice?

  • With more than 5 years of expertise in medical device regulatory compliance services.

  • Our team comprises seasoned and qualified professionals who are authorities in medical device regulatory compliance.

  • We provide an extensive array of services that encompass every facet of the MD 5 licensing process.

  • We are dedicated to delivering top-notch services and assistance to our clients.

Frequently Asked Questions — MD-5 License

What is MD 5 license for medical devices?

MD 5 is the manufacturing license issued by State Licensing Authority for Class A and B medical devices in India under Medical Device Rules 2017.

What is Form MD 3?

Form MD-3 is the application form submitted to State Licensing Authority to obtain MD-5 manufacturing license for Class A and B medical devices.

What is the fee for MD 5 license?

The fee for MD-5 license is Rs. 5,000 per manufacturing site and Rs. 500 for each distinct medical device.

Is ISO 13485 required for MD 5 license?

Yes, ISO 13485 or ICMED 13485 certification is mandatory for obtaining MD-5 license for Class A and B medical device manufacturing.

Who issues MD 5 license in India?

MD-5 license is issued by the State Licensing Authority (State FDA) of the respective state where manufacturing takes place.

You can reach us anytime via info@zyps.co.in

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