Introduction to CDSCO MD9 Manufacturing License for Medical Devices
The MD-9 License is a regulatory requirement in India for manufacturers of Class C and Class D medical devices. Governed by the Central Drugs Standard Control Organization (CDSCO), it ensures that these devices meet specific safety and quality standards. Obtaining this license is essential for manufacturers to legally produce and sell their devices within the country. It signifies adherence to India’s stringent medical device regulations, safeguarding public health.
Important Deadline for Class C and D Licensing: CDSCO has transitioned Class C and Class D rehabilitation medical devices from the mandatory registration protocol to a licensing framework as detailed in GSR 102(E) dated 11.02.2020. This pivotal transition will be operational from October 1, 2023. Official Notice – Link
This means you have till Sept 30, 2023, to apply for the License.
Classification of Medical Devices in India
Medical devices in India are classified into four categories based on their potential risk:
Class A (Low Risk) Medical Devices
- Medical Devices that pose minimal potential harm to the user.
- Regulation: Subject to general controls and may be exempt from premarket notification.
- Examples: Elastic Adhesive Bandages, examination gloves, absorbent cotton, and some hand-held surgical instruments.
- Safety Concern: Least potential for harm; mostly external use.
Class B (Low Moderate Risk)
- Definition: Devices with a higher risk than Class A and require greater regulatory controls to provide a reasonable assurance of safety and effectiveness.
- Regulation: Subject to general controls and may need special controls like patient registries for implantable devices.
- Example: Hypodermic needles, suction equipment, thermometer, catheter, IV canula, and blood pressure monitoring devices.
- Safety Concern: Potential harm is moderate; can be both external and internal devices.
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Class C (Moderate-High Risk)
- Definition: Devices that have a higher risk than Class B and are usually implantable or life-supporting.
- Regulation: Subject to general controls, special controls, and MD9 licensing.
- Example: Bone plates, powered wheelchairs, and infusion pumps.
- Safety Concern: Can cause significant harm; often implantable or life-sustaining.
Class D (High Risk)
- Definition: Devices that sustain or support life, are implanted, or present a potentially unreasonable risk of illness or injury.
- Regulation: Subject to the strictest regulatory controls and require premarket approval.
- Examples: Heart valves, implantable pacemakers, ventilators, etc.
- Safety Concern: Highest potential for harm; critical for life support or sustenance.
Class C and Class D devices, given their higher risk potential, require strict regulatory oversight, which is where the MD-9 License is needed
Requirements for CDSCO MD9 Medical Device Manufacturing License
Document Required for the Registration Process:
- Residence Proof
- Constitution Proof (GST Certificate / CIN / MOA AOA)
- Premises Ownership Proof
- Documents of Manufacturing Chemist
- Documents of Chemical Testing Staff
- List of Products
- Fire and Pollution NOCs
- Machine Details
- Device Master Files
- Plant Master Files
- Trademark Certificate
Contents of a Device Master File (DMF):
- Administrative Information: Key contact details and table of contents.
- Device Description: Overview of device and its intended use.
- Materials: List of materials, sources, and quality specifications.
- Manufacturing: Process flow, equipment details, and validation.
- Quality Control: Testing procedures and acceptance criteria.
- Sterilization: Method details and validation.
- Packaging and Labeling: Packaging components and labeling artwork.
- Performance Testing: Bench and in-vivo/in-vitro test summaries.
- Safety Testing: Risk analysis and safety test results.
- Clinical Information: Clinical study design and outcomes.
Read more about Device Master Files
Steps of CDSCO MD9 License Registration
Step 1 – Applicant Registration
- Getting Started: Before diving into the application, ensure you have an active account on the CDSCO online registration portal.
Step 2 – MD9 License Application
- Form Details: The application is filed on Form MD7. The online form will require specifics like the device’s classification, brand name, intended use, and a detailed product description.
- Document Submission: Upload essential documents in line with Indian CDSCO regulations. This might include regulatory certificates like European CE, free sale certificate, ISO 13485, Plant Master File, and Device Master File.
- Fee Payment: Pay the CDSCO fee, which varies based on the device’s classification.
- Confirmation: Once all documents are submitted and fees are paid, you’ll receive an application number, confirming successful submission.
Step 3 – Application Review by CDSCO
- Thorough Examination: CDSCO will meticulously review the application and all attached documents.
- Open Communication: If there are queries or discrepancies, CDSCO will reach out for clarification.
- Your Response: It’s crucial to promptly submit any requested justifications or revised documents through the CDSCO online portal.
Step 4 – CDSCO Audit
- Our Team helps get your factory premises and documentation up to CDSCO standards.
- CDSCO’s officials audit your factory and raise queries if they observe any discrepancy with your factory or documentation.
- Our team replies to those queries
Step 5 – License Approval
- Final Review: CDSCO will once again review and comment on the justifications and documents. If everything aligns with their regulations, they’ll move forward.
- License Grant: Meeting all criteria and addressing all queries will result in the granting of the MD9 Manufacturing license for Class C and Class D medical devices.
- Expertise in CDSCO Regulations: Our team is well-versed with the nuances of CDSCO guidelines and the Indian Medical Device Regulation. We ensure that your application aligns perfectly with the regulatory requirements, increasing the chances of swift approval.
- End-to-End Assistance: From initiating the applicant registration to celebrating the license approval, we’re with you at every step. Our comprehensive service ensures that no detail, however minute, is overlooked.
- Time-Efficient Processes: We understand the value of time in the medical device industry. Our streamlined processes, backed by years of experience, ensure that your application is processed in the shortest time frame possible.
- Document Preparation and Review: With our in-depth knowledge of the required documentation, from Plant Master Files to Device Master Files, we not only assist in preparing these documents but also review them to ensure accuracy and completeness.
- Regular Updates: The waiting period can be stressful. We provide regular updates on the status of your application, ensuring you’re always in the loop.
- Post-License Support: Our relationship doesn’t end with the license approval. We offer post-license support, assisting with renewals and any regulatory changes that might affect your business.
- Cost-Effective Solutions: Quality doesn’t always have to come at a high price. Our competitive pricing ensures you get the best services without burning a hole in your pocket.
- Client-Centric Approach: At Pharmadocx Consultants, our clients are our top priority. We tailor our services to meet your specific needs, ensuring a personalized experience.
In the ever-evolving landscape of medical device regulations in India, having a trusted partner can make all the difference. Let Pharmadocx Consultants be that partner, guiding you toward success in the Indian medical device market. Reach out to us today and take the first step towards hassle-free CDSCO manufacturing licensing.
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Frequently Asked Questions (FAQs)
What is CDSCO and its role in medical device manufacturing licensing?
CDSCO stands for Central Drugs Standard Control Organization. It’s the primary regulatory body in India overseeing the safety, efficacy, and quality of drugs, cosmetics, and medical devices. It’s responsible for granting manufacturing licenses for medical devices.
How long is the CDSCO MD 9 manufacturing license for medical devices valid?
The CDSCO manufacturing license for medical devices has perpetual validity however after every 5 years, a fees of Rs. 50,000 as a retention fees of license is payable.
What documents are required for CDSCO medical device manufacturing licensing?
Residence Proof, Constitution Proof (GST Certificate / CIN / MOA AOA), Premises Ownership Proof, Documents of Manufacturing Chemist, Documents of Chemical Testing Staff, List of Products, Fire and Pollution NOCs, Layout, Machine Details, Device Master Files, Plant Master Files, Trademark Certificate
How does the classification of medical devices by CDSCO impact the licensing process?
CDSCO classifies medical devices based on risk. The classification determines the documentation and fees required.
How long does it typically take to get a CDSCO manufacturing license for medical devices?
Usually it takes 2-3 months to get CDSCO MD9 manufacturing License for Medical Devices. The duration varies based on the device’s classification and documentation. With our 27 years of experience, Pharmadocx Consultants can expedite the process for you.
What are the fees associated with the CDSCO MD9 Manufacturing license application?
The fee is Rs. 50,000 for the license + Rs. 1,000 for each product registration.
What is form MD-7 in CDSCO?
Form MD-7 is the application form for obtaining an MD-9 manufacturing license for medical devices from CDSCO.
Where to apply for a medical device manufacturing license?
Applications are submitted through the CDSCO online portal. Let Pharmadocx Consultants handle the intricacies for you.
Can I transfer my CDSCO manufacturing license to another entity or individual?
No, you can’t transfer a CDSCO MD9 Manufacturing License for Medical Devices to anyone else.
What is a CDSCO MD-9 License?
The MD-15 license is a specific authorization issued by CDSCO for the manufacturing of Class C and Class D medical devices in India, ensuring they meet the necessary safety and quality standards.