CDSCO License for Amniotic membrane perforator, reusable

Comprehensive Guide to CDSCO Licensing for Amniotic Membrane Perforator, Reusable (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience assisting 500+ companies in the Indian medical device market, we understand the nuances of obtaining CDSCO licenses for surgical instruments like the Amniotic membrane perforator, reusable. This device, classified as Class A under the Obstetrical and Gynecological category, plays a crucial role in safely rupturing the amniotic membrane during childbirth without causing harm to mother or fetus. Navigating the regulatory framework effectively is essential to ensure timely market entry and compliance with Indian laws.

CDSCO Regulatory Framework for Amniotic Membrane Perforator

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. The Amniotic membrane perforator falls under Class A, the lowest risk category, and is regulated by the State Licensing Authority. Compliance involves obtaining the MD5 manufacturing license for domestic manufacturers or the MD15 import license for importers.

Risk Classification and License Requirements

• Device Name: Amniotic membrane perforator, reusable
• Risk Class: Class A (Low Risk)
• Category: Obstetrical and Gynecological
• Regulatory Notification: File No. 29/Misc./03/2020-DC (181), dated 03.06.2022

Class A devices require the MD5 license (form MD3) granted by the respective State Licensing Authority. The process includes obtaining a test license (Form MD13), product testing from government-approved laboratories, document submission, audit by notified bodies, and final license grant.

For more details on risk classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD5)

1. Apply for Test License (Form MD13): Initiate by applying for a test license to legally manufacture the device for testing purposes. This step usually takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories to demonstrate safety and efficacy. Refer to the Testing Laboratories list.
3. Document Preparation: Compile all necessary documentation, including quality and risk management files.
4. Submit Manufacturing License Application (Form MD3): Apply for the MD5 license through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts a facility audit to ensure compliance with MDR 2017 requirements. Check the list of notified bodies.
6. Resolve Queries: Address any queries raised by the CDSCO or notified body promptly.
7. License Grant: Upon satisfactory audit and document review, the State Licensing Authority issues the MD5 license (Form MD5).

Our detailed MD5 License guide provides further insights into this process.

Manufacturing License Documents Required

To ensure smooth application processing, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of ownership or lease agreement of manufacturing premises
• Technical staff qualifications and experience certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications and design (see our Device Master File guide)
• Plant Master File describing manufacturing facilities and processes (Plant Master File guide)
• Essential Principles Checklist confirming conformity to regulatory standards
• Risk Management File documenting hazard analysis and mitigation (Risk Management guide)
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents such as ISO 13485 certification

Attention to detail in these documents reduces the risk of delays or rejections.

Import License Process (MD15)

For importers of the Amniotic membrane perforator, the MD15 import license is required, granted by the Central Licensing Authority. The process involves:

• Document preparation including manufacturer’s MD5/MD9 license
• Submission of application on the CDSCO MD Online Portal
• Review and query resolution by CDSCO
• License grant on Form MD15

Since Class A devices have relatively lower import fees and simpler documentation, importers should leverage the Import License guide.

Import License Documents Required

• Manufacturer’s valid MD5 or MD9 manufacturing license
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale license for importer
• Company Constitution

Timeline and Processing Duration

Planning ahead and preparing documents in advance can reduce processing times significantly.

Government Fees and Costs

• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product
• Test License (MD13): Nominal fees apply (varies by state)
• Testing Costs: Depending on test parameters, approximately Rs 50,000 – Rs 1,00,000 per product

Note: Costs can vary based on notified body audit fees and lab testing charges.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all forms and supporting documents are complete and accurate. Use checklists to avoid omissions.
• Delays in Testing: Schedule tests early and choose reputed CDSCO-approved labs.
• Audit Non-Compliance: Prepare your facility and staff to meet MDR 2017 norms. Conduct internal audits beforehand.
• Query Management: Respond to CDSCO queries promptly and comprehensively to avoid prolonged delays.

Our experience shows that proactive communication and thorough preparation are key to overcoming these challenges.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time applicants. With our extensive experience guiding over 500 companies, we offer end-to-end support:

• Documentation review and gap analysis
• Liaison with CDSCO officials and notified bodies
• Audit preparation and mock inspections
• Product testing coordination
• Post-license compliance assistance

Engaging expert consultants can significantly improve approval odds and reduce time-to-market.

Getting Started with Your CDSCO License Application for Amniotic Membrane Perforator

1. Register on the CDSCO MD Online Portal. Secure your user credentials to access application forms.
2. Assess your device classification and licensing requirements. For this Class A device, plan for the MD5 license.
3. Prepare your test license application (Form MD13) and submit early. This allows legal manufacture for testing.
4. Engage a CDSCO-approved testing laboratory and schedule product testing.
5. Develop or update your Device Master File, Plant Master File, and Risk Management File. Ensure compliance with the latest standards.
6. Compile all supporting documents per checklist and submit the MD5 application (Form MD3).
7. Coordinate with notified bodies for audits and respond rapidly to any queries.

Following these practical steps will set a strong foundation for successful CDSCO license acquisition. Reach out to us for tailored support to streamline this journey and achieve compliance efficiently.