An Overview:
Medical devices play a crucial role in modern healthcare, ensuring effective diagnosis and treatment. However, before a medical device can be imported and marketed in India, it must comply with the regulations laid out by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules, 2017. One of the primary requirements is obtaining an import license in Form MD-15.
In this blog, we outline the comprehensive checklist for applying for a fresh import license, endorsement for additional devices, and retention of an existing import license under Form MD-15.
Also read our blog on MD 15 License: Gateway to Import Medical Devices in India.
Looking For a Medical Device Regulatory Consultant?
Let’s have a word about your next project
What is Form MD-15 Under Medical Devices Rules, 2017?
Form MD-15 is the official license granted by CDSCO for the import of medical devices in India. It ensures that the devices meet safety and quality standards and have been assessed according to international and Indian regulatory requirements.
To obtain Form MD-15, applicants need to submit an application via Form MD-14. The checklist varies slightly depending on whether the application is for a new license, endorsement of additional devices, or retention of an existing license.
Checklist for Fresh Applications in Form MD-14
If you’re applying for a new import license, ensure that the following documents are prepared:
- Covering Letter – A detailed application overview.
- Application in Form MD-14 – Complete with all relevant details.
- Fee Challan – Proof of payment.
- Power of Attorney – Authenticated by relevant authorities in India or abroad.
- Wholesale/Manufacturing License – Proof of authorization.
- Constitution Details – Of the authorized agent.
- Regulatory Certificates:
- Free Sale Certificate from the country of origin or trusted markets like the US, EU, or Japan.
- Manufacturing site registration and audit reports.
- Quality Certificates:
- Quality Management System (QMS) Certificate.
- CE Certification or equivalent.
- Plant Master File – As per Appendix I of the Fourth Schedule.
- Device Master File – Detailed as per Appendix II, including specifications, safety compliance, risk analysis, and clinical data.
- Additional Documents – As applicable.
Checklist for Endorsement Applications
To endorse additional devices to an existing license:
- Submit a fresh Form MD-14 and Power of Attorney.
- Include the existing import license.
- Provide updated Regulatory Certificates and Quality Certificates.
- Ensure the Device Master File reflects accurate grouping and specifications for the new devices.
Checklist for Retention of Import License
For retaining an existing license, CDSCO mandates:
- Retention Form and Fee Challan.
- A copy of the existing import license and its endorsements.
- Post-marketing surveillance data, including complaints and recalls.
- Valid Free Sale Certificates and Quality Certificates.
- An undertaking confirming no changes in the Device Master File or Plant Master File unless updated.
Key Considerations for Compliance
- Regulatory Certificates must be duly notarized.
- Documentation Accuracy is essential to avoid delays in approval.
- The manufacturer must provide valid declarations for conformity, quality management, and post-market surveillance.
- Fees must align with the number of products and their classifications.
How Operon Strategist Can Assist You
Navigating the intricate regulatory pathways for obtaining an MD-15 import license can be overwhelming. At Operon Strategist, we specialize in providing end-to-end consulting services for medical device manufacturers and importers.
- Document Preparation: We ensure your application meets CDSCO requirements.
- Regulatory Compliance: Expert guidance on fulfilling quality and safety certifications.
- Turnkey Solutions: Comprehensive support for establishing compliance-ready systems.
Simplify Your Form MD-15 Import License Process With Operon Strategist’s Expert Guidance!
Conclusion
Obtaining an import license in Form MD-15 is a critical step for importing medical devices into India. By adhering to the CDSCO checklist and ensuring proper documentation, you can secure a seamless approval process. With expert partners like Operon Strategist, your compliance journey becomes efficient and hassle-free.
For more insights and assistance, reach out to Operon Strategist—your trusted partner in medical device regulatory consulting.
