+91 9910316549
info@zyps.co.in
Contact
Contact
Contact
Contact

License for Manufacturing Class C and D Medical Devices in India - MD 9

Manufacturers of Class C and Class D medical devices in India are obligated to obtain the MD 9 Medical Device License, which is issued by the Central Drugs Standard Control Organisation (CDSCO).

Acquiring an MD 9 License necessitates compliance with specific criteria, such as maintaining a skilled workforce, possessing an appropriate production facility, and implementing a robust quality management system. The procedure for obtaining an MD 9 License is intricate and may extend over several months.

For manufacturers of Class C or Class D medical devices in India, securing an MD 9 License is imperative for legal business operations. Reach out to ZYPS Experts today for further information on the MD 9 Medical Device License and the application procedure.

ZYPS Experts offers comprehensive services to facilitate the application and acquisition of the MD 9 License from the CDSCO for manufacturing Class C and D Medical Devices, including In-Vitro Diagnostic Devices. Our all-inclusive solution ensures a seamless process from initiation to the successful issuance of the MD 9 license.

Attention to all medical device manufacturers in India!

Final opportunity to apply for the MD 9 Medical Device License for Class C and D devices!

The Ministry of Health and Family Welfare has provided a transition period of 42 months to obtain an MD 9 Medical Device License for Class C and Class D Devices. This implies that the deadline to apply for the license is September 30, 2023. Subsequently, it will be compulsory for all manufacturers to possess an MD-9 License to engage in the manufacturing, sale, or distribution of Class C and Class D medical devices in India.

The transition period outlined in Notification No. GSR 102 (E) is scheduled to end on September 30, 2023.

Apply for your MD 9 Medical Device License today.

The Classification of Medical Devices in India

Medical devices in India are categorized into four classes according to the degree of risk they present to patients. This classification framework is outlined in Chapter 2 of the Medical Device Rules, 2017, and encompasses all medical devices, including in-vitro diagnostic devices.

Class A

  • Low risk
  • Low complexity
  • Minimal potential harm
  • Examples: tongue depressors, bandages, and surgical masks

Class B

  • Low to moderate risk
  • Moderate complexity
  • Greater potential for harm if not used properly
  • Examples: syringes, dental cement, pregnancy detection kits, and nebulizers

Class C

  • Moderate to high risk
  • High complexity
  • Higher potential for harm if not used correctly or if any malfunctions occur
  • Examples: implantable devices, surgical lasers, and cardiac pacemakers

Class D

  • High risk
  • Highly complex and invasive
  • Significant potential for harm if not used appropriately
  • Examples: heart valves, advanced surgical instruments, life-supporting devices

The Central Licensing Authority (CLA) categorizes medical devices according to their intended purposes and defined criteria, and releases the List of Notified Medical Devices on the Central Drugs Standard Control Organisation (CDSCO) website.

bg-1
What is Form MD 7?
  • Form MD 7 serves as the official application document required to request a license for manufacturing Class C or Class D medical devices in India.
  • It is provided by the Central Drugs Standard Control Organisation (CDSCO).
  • Manufacturers are required to submit Form MD 7 in order to obtain the MD 9 License for manufacturing Class C or Class D medical devices in India.

What is Form MD 9?
  • MD 9 is the official license issued by CDSCO for the production of Class C or Class D medical devices in India.

  • It is granted subsequent to the CDSCO's review and approval of the application form.

  • To legally manufacture, sell, or distribute their products, manufacturers of Class C or Class D medical devices in India must possess an MD 9 medical device license.
bg-1
bg-1

Requirements for Acquiring MD 9 Medical Device License for Class C and Class D Devices

To secure an MD 9 Medical Device License for Class C and Class D Devices, the applicant must fulfill the following criteria:

  • The manufacturing facility must adhere to the Quality Management System standards of ISO 13485 or ICMED 13485.
  • Adherence to environmental regulations.
  • All required documentation for the MD 9 License.
  • The applicant must designate skilled technical personnel for the manufacturing and testing of medical devices.

Manufacturing Staff

The manufacturing personnel must possess the following qualifications and experience:

  • A recognized university degree in engineering, pharmacy, or science, along with a minimum of 2 years of experience in medical device manufacturing.
  • A diploma in engineering or pharmacy from an accredited institute, coupled with a minimum of 4 years of experience in medical device manufacturing.

Testing Staff

The testing personnel must possess a degree or diploma in engineering, pharmacy, or science, along with a minimum of 2 years of experience in testing medical devices.

Documentation required for submission to CDSCO for the MD 9 Medical Device License.

  • An application Form MD 7
  • Covering Letter
  • Constitution of the Firm
  • Sale Deed / Rent Deed
  • ISO 13485 Certificate
  • Quality Manual
  • Quality Management System Procedures
  • Site Master File
  • Executive Summary of the Device
  • Device Description and product specifications, including variants and accessories
  • Product Specification
  • Reference to predicate or previous generations of the device
  • Labels and Instruction for Use
  • Device Design and Manufacturing Information
  • Essential Principles Checklist
  • Risk analysis and control summary
  • Verification and validation of the medical device
  • Design verification and validation
  • Biocompatibility validation data
  • Medicinal substances data (if device contains Drug)
  • Biological Safety
  • Sterilization Validation data
  • Software verification and validation (if software used)
  • Animal studies – Preclinical data
  • Stability validation data
  • Clinical evidence
  • Post Marketing Surveillance data
  • Certificate of Analysis of finished product for minimum 3 consecutive batches
  • Prescribed Fee

Applying for an MD 9 Medical Device License

When submitting an application to acquire an MD 9 Medical Device License for Class C and Class D Devices, the applicant must meet the following criteria:

  • Step 1: Enroll your organization on the CDSCO's SUGAM Portal.
  • Step 2: Submit your application for the MD-9 Medical Device License for Class C and Class D Devices via Form MD-7 on the CDSCO's online SUGAM Portal.
  • Step 3: Upload the necessary documents and proceed with the payment of the fee. The essential documents comprise the Memorandum of Association, Sale/Rent Deed, Plant Layout, Site Master File, Device Master File for each product, Performance Evaluation Report, etc.
  • Step 4: The CDSCO team will review your application for compliance. If it meets the requirements, it will proceed to undergo a quality management system compliance audit conducted by the CDSCO team.
  • Step 5: The CDSCO Team will perform the audit at the applicant's manufacturing premises. If any Non-Conformance (NC) is identified by the audit team, it will be communicated through the CDSCO's SUGAM Portal, and you will be required to submit a NC closure report along with supporting evidence.
  • Step 6: Upon fulfillment of all conditions outlined in the MD-9 Medical Device License for Class C and Class D Devices, the CDSCO will grant the license.

Are you in search of an MD 9 License to manufacture Class C or D 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 ensure the approval of your MD 9 license.

CONTACT US NOW

What is the processing time for obtaining the MD 9 License?

It can take 3 to 6 months to get an MD 9 License to manufacture Class C or D Devices from the CDSCO.

MD 9 Medical Device License Validity

A license issued in Form MD-9 shall remain valid indefinitely, as long as the applicant pays the retention fee every five years from the date of issue of the license.

MD 9 Medical Device License Renewal

To keep your MD 9 Medical Device License valid, you must pay the retention fee every five years from the date of issue.

The Fee of an MD 9 Medical Device License in India

The manufacturing license for Class C or D medical devices in India is priced at ₹50,000. An additional fee of ₹1,000 will be applied for each unique medical device.

How does ZYPS Experts assist in obtaining MD 9 Medical Device License for Class C-D Devices in India?

  • We will check and guide you to classify your devices depending on their risk and give you clear guidance.
  • We will conduct a pre-audit to check whether or not your manufacturing unit complies with CDSCO requirements.
  • We will help and assist you to prepare your Device Master File as per Medical Device Rule.
  • We will guide you to prepare and comply with the Audits by CDSCO.
  • If any query is raised by the assessing team of regulatory body, we will guide you to submit compliance for the raised query.
  • We provide reliable and on-time complete end-to-end guidance to get your Medical Device Licence at an affordable cost.

How to comply with the Quality Management System for MD 9 License?

To comply with the Quality Management System for MD 9 License, you can follow these steps:

  • 1. Get ISO 13485:2016 certified. ISO 13485 is an international standard that sets out the requirements for a quality management system for the design, development, production, installation, and servicing of medical devices. Getting ISO 13485 certified is the best way to demonstrate to the CDSCO that your quality management system meets the requirements of the MD 9 License.

  • 2. Implement a quality management system that complies with the requirements of ISO 13485:2016. This includes developing and implementing procedures for all aspects of your medical device business, such as product design, development, manufacturing, quality control, and customer service.

  • 3. Maintain your quality management system. This includes conducting regular internal audits to ensure that your system is still effective and making any necessary changes to improve your system.

You can also contact ZYPS Experts to help you comply with the Quality Management System for MD 9 License. We can help you develop and implement a quality management system, get ISO 13485 certified, and maintain your quality management system.

Additional tips for complying with the QMS for MD 9 License:

  • Make sure that your quality management system is documented and that all employees are trained on the procedures.

  • Conduct regular risk assessments to identify and mitigate potential risks to the quality of your medical devices.

  • Get regular external audits from a qualified auditor to ensure that your quality management system meets the requirements of ISO 13485:2016.

By following these tips, you can ensure that your quality management system meets the requirements of the MD 9 License and that you are producing high-quality medical devices.

Passing Your CDSCO Audit for MD 9 License: Key Steps for Manufacturers

The CDSCO conducts a thorough audit of your manufacturing premises to ensure compliance with Medical Device Rules, 2017. This audit covers critical areas like facility readiness, quality management systems, device master files, risk management, validation, testing, and manufacturing processes.

Obtaining your MD 9 License and entering the thriving Indian medical device market is within reach. But navigating the CDSCO audit can feel like scaling Mount Everest. Don’t worry, we’re here to equip you with the tools and knowledge to reach the summit!

Here are 5 powerful steps to ensure a smooth and successful CDSCO audit:

1. Documentation Detox: Polish Your Paperwork for Perfection

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

  • Ensure your documentation is up-to-date, accurate, and aligned with the latest MD 9 License requirements. Don’t let inconsistencies or outdated info trip you up!

  • Upgrade your QMS to international standards like ISO 13485. Robust design control, risk management, and post-market surveillance processes impress auditors.

2. Facility Readiness: Transform Your Space for GMP Compliance

  • Give your manufacturing facility a thorough makeover to comply with Good Manufacturing Practices (GMP). Cleanliness, organization, and functionality are key.

  • Address any non-compliance issues promptly.

  • Remember, CDSCO auditors scrutinize your environment, so make it shine!

3. Testing of Devices: Prove Your Products' Prowess

  • Put your medical devices through their paces with rigorous testing and validation. Ensure they meet all specified standards and have undergone testing for biocompatibility, sterilization, and other relevant aspects.

  • Leave no room for doubt – thorough testing demonstrates your commitment to quality and safety.

4. Risk Management: Master the Art of Mitigating Mishaps

  • Become a risk management ninja! Identify, assess, and proactively mitigate potential risks associated with your devices.

  • Document your risk assessments and mitigation strategies clearly to showcase your dedication to patient safety.

5. Training Needs: Build a Team of Quality Crusaders

  • Invest in your team’s expertise! Train your staff on the latest regulatory requirements and ensure they’re competent in implementing quality procedures.

  • A well-trained and knowledgeable team impresses auditors and guarantees consistent quality.

By following these 5 powerful steps, you’ll transform your CDSCO audit from a daunting challenge into a triumphant opportunity. Remember, with meticulous preparation and expert guidance, securing your MD 9 License and launching your medical devices in India is a dream you can hold in your hands.

Concerned about the upcoming CDSCO Audit?

ZYPS Experts guides you through every step of the audit process, ensuring compliance with Medical Device Rules, 2017. Our experts assess facility readiness, quality management systems, device master files, risk management, validation, testing, and manufacturing processes.

Schedule a free consultation today and learn how we can help you achieve smooth CDSCO approval.

CONTACT US NOW

How to Renew Your MD 9 License: Process & Required Documents

Renewing your MD 9 License is crucial to maintain compliance and continue manufacturing or selling medical devices in India. Here’s a breakdown of the key deadlines and fees to avoid penalties or license cancellation:

Key Renewal Deadlines:

  • 5-Year Renewal Period: Your MD 9 License must be renewed every 5 years from the original date of issue.

  • Grace Period for Late Payments: If you miss the renewal deadline, you have a 180-day grace period to pay the renewal fee, but a late fee of 2% per month will be added.

  • License Cancellation: Failure to pay the renewal fee within 180 days will result in automatic cancellation of your license.

Renew Your MD 9 License Effortlessly: A Step-by-Step Guide for Manufacturers

Want to ensure uninterrupted manufacturing of your medical devices in India? Renewing your MD 9 License is key! Here’s the simple way to do it online:

  • Head to the SUGAM Portal: This is the official platform for medical device licensing in India.

  • Choose “Retention”: Let the system know you’re not applying for a new license, but renewing your existing one.

  • Download the Guide: For step-by-step instructions with screenshots, grab the handy guide right on the SUGAM Portal.

That’s it! Just follow the clear instructions and submit your application along with the required documents. It’s smooth sailing from there!

Remember: Staying compliant with MD 9 license renewal keeps your business running smoothly and avoids any hassles. So, start the process today and enjoy peace of mind!

Documents required to get renew of MD 9 License

To renew the MD 9 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 9 License. Be sure to list all the devices covered and mention the fee payment details.

2. Undertaking

To renew your MD 9 License, just submit a signed statement saying your company structure (Constitution of the Firm) and product information (Plant Master File & Device Master File) haven’t changed.

3. Details of Technical staff

To renew your MD 9 License, showcase your expert technical staff who ensures top-notch device manufacturing. Just share details of your technical staff like:

  • Engineers or scientists: With a relevant degree and at least 2 years of experience in medical device manufacturing or testing.

  • Pharmacists or engineers with diplomas: In relevant fields, and at least 4 years of experience in making or testing medical devices.

Don’t forget! Include details of someone with a degree/diploma and at least 2 years of testing experience to oversee those important quality checks.

4. Post Marketing Surveillance data

To keep your MD 9 License going strong, 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 – 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. Manufacturing License

You need to submit the copy of existing manufacturing license for which retention is applied.

6. Post Approval Change Applications (If Any)

Did you modify your medical device after getting your MD 9 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.

Frequently Asked Questions for MD 9 Medical Device License

Who can apply for MD 9 License?

Companies that intend to manufacture Class C or Class D medical devices and in-vitro diagnostic devices on their premises can apply for MD 9 License.

Why do you need an MD 9 Medical Device License?

To legally manufacture Class C or Class D medical devices or in-vitro diagnostic devices in India, you need an MD 9 License.

Where can I get the Device Master File (DMF) for the MD 9 License?

ZYPS Experts provides the Device Master File for medical devices and in-vitro diagnostic medical devices.

Where can I get the Plant Master File required by the CDSCO?

ZYPS Experts provides customized and CDSCO-compliant plant master files.

How long does it take to get the MD 9 License?

It can take 3 to 6 months to get an MD 9 License to manufacture Class C or D Devices from the CDSCO.

Who issues the MD 9 license?

The MD 9 license is issued by the Central Drugs Standard Control Organisation (CDSCO) in India to manufacture Class C or D medical devices and in-vitro medical devices.

What is the difference between Form MD 7 and MD 9?

Form MD 7 is the application form to get a license to manufacture Class C or Class D devices and Form MD 9 is a legal license issued by the CDSCO to the applicant to manufacture Class C or D devices in India.

Can I change the manufacturing location after obtaining an MD 9 License?

Any change in the manufacturing location can be done through post-approval changes.

Our Services

We offer a comprehensive service of medical device licensing and registration in India, including:

  • Medical Device Registration and License

  • Medical Device Import License

  • Medical Device Wholesale License

  • ISO Certification

  • GMP Compliance

  • FDA Product Listing

  • 510(k) Submission

  • CE Documentation

  • BIS Certification (ISI Marking)

  • Import License for Cosmetic Products

  • Medical Device Labeling Compliance

  • Cosmetic Import License from CDSCO

bg-1

How ZYPS Experts can help you get an MD 9 License

ZYPS Experts is a leading medical device consulting company in India that provides services to help companies obtain MD 9 Licenses. We offer a comprehensive range of services, including:

  • Application Form MD 7 Submission: We will help you complete and submit Form MD 7, the application form for the grant of license to manufacture Class C or D medical devices and in-vitro diagnostic devices.

  • SOP and Format Development: We will guide you in developing comprehensive Standard Operating Procedures (SOPs) and documentation formats that align with your Quality Management System (QMS) requirements and regulatory standards.

  • QMS Certification: We will help you create and establish a robust QMS tailored to meet ISO 13485 standards and provide ISO 13485 certification.

  • Mock Audit Preparation: We will conduct a mock audit internally to identify areas for improvement and ensure readiness for the upcoming audit by Notified Bodies.

  • Audit by CDSCO: We will facilitate and actively participate during the audit process conducted by the CDSCO, ensuring all compliance measures are met.

  • SUGAM Portal Query Responses: We will guide you in preparing and submitting detailed responses to any queries raised by the licensing authority (CDSCO) during the licensing process.

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

Meet Our Experts