CDSCO License for Plastic surgery osteotome
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument.
Comprehensive Guide to CDSCO Licensing for Plastic Surgery Osteotomes (Class A Medical Device)
As a trusted regulatory consultant with over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we understand the critical regulatory landscape for medical devices in India. This guide specifically addresses the licensing requirements for Plastic Surgery Osteotomes, classified as Class A devices under the CDSCO framework. Our goal is to provide detailed, actionable insights into the licensing process, timelines, costs, and necessary documentation to help manufacturers and importers successfully navigate Indian regulations.
Understanding Plastic Surgery Osteotomes and Their Regulatory Importance
A Plastic Surgery Osteotome is a surgical, chisel-like instrument used primarily in dermatological and plastic surgery to cut or shape small bones and cartilage. It is manually operated with a surgical mallet, making it a precision device requiring strict compliance with regulatory standards to ensure patient safety and device efficacy.
Given its classification as a Class A medical device—a low-risk category under the CDSCO Medical Device Rules—it must adhere to specific licensing protocols before market entry in India. Complying with these regulations is essential for legal distribution and maintaining high-quality standards.
CDSCO Regulatory Framework for Plastic Surgery Osteotomes
The Central Drugs Standard Control Organization (CDSCO) oversees medical device regulation in India. For Class A devices like the Plastic Surgery Osteotome, manufacturing licenses are issued by the State Licensing Authority through the MD5 license process. This process includes initial testing, documentation, audits by notified bodies, and adherence to quality management systems.
Risk Classification and License Requirements for Plastic Surgery Osteotomes
Plastic Surgery Osteotomes fall under Class A according to the CDSCO notification 29/Misc./03/2020-DC (147) dated 26.7.2021. This classification denotes a low-risk device, subject to the following:
- Manufacturing License: MD5 license (Application Form MD3)
- Issuing Authority: State Licensing Authority
- Total Processing Time: Approximately 3-4 months
- Initial Test License: MD13 (Test License)
For a thorough explanation of device classification, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process for Plastic Surgery Osteotomes (MD5 License)
The MD5 license process involves several key steps:
- Apply for Test License (Form MD13): Allows product testing in government-approved laboratories. This step takes about 1.5 to 2 months.
- Product Testing: Conducted at CDSCO-approved labs. Refer to the Testing Laboratories list for options.
- Document Preparation: Compile all technical and regulatory documents, including Device Master File and Plant Master File.
- Application Submission: File the MD5 license application (Form MD3) via the CDSCO MD Online Portal.
- Audit by Notified Body: An audit is conducted to verify compliance. Check the list of notified bodies for authorized auditors.
- Query Resolution: Address any queries raised during the audit or by the licensing authority.
- License Grant: Upon successful evaluation, the license is granted on Form MD5.
Documents Required for MD5 Manufacturing License Application
Manufacturers must prepare a comprehensive set of documents, including:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire No-Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design and specifications (Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing processes (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with CDSCO standards
- Risk Management File documenting hazard analysis and mitigation (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485 certification recommended)
Import License Process for Plastic Surgery Osteotomes (MD15 License)
If you are an importer rather than a manufacturer, the import license process differs and is governed by the MD15 license issued by the Central Licensing Authority. This process generally takes 5-6 months and does not require a test license. Key steps include:
- Document preparation (including manufacturing license from country of origin, Free Sale Certificate, ISO 13485, CE Certificate, DMF, PMF, wholesale license)
- Application submission on the CDSCO MD Online Portal
- Resolution of any queries raised
- License grant on Form MD15
For detailed guidance, consult our Import License guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| Application Review & Audit | 1 – 1.5 months |
| Query Resolution & Final Grant | 2 – 4 weeks |
Total estimated time: 3 to 4 months for MD5 license issuance.
Government Fees and Costs
- MD5 Manufacturing License: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs include testing fees at government-approved labs and potential audit charges by notified bodies.
Common Challenges and Practical Solutions
- Incomplete Documentation: Many applicants face delays due to missing or insufficient technical files. We recommend early preparation of Device Master Files and Plant Master Files to streamline the process.
- Delayed Testing: Scheduling product testing can be time-consuming. Plan testing early and select accredited labs from the Testing Laboratories list.
- Audit Readiness: Non-compliance found during audits can postpone licensing. Engage with experienced notified bodies listed here and conduct internal pre-audit checks.
- Query Management: Prompt and thorough responses to CDSCO queries are essential. Maintain a dedicated regulatory team or consultant to address these efficiently.
Expert Consultation and Support
With decades of regulatory expertise, we guide manufacturers and importers through every step—from initial classification and documentation to audit preparation and final license issuance. Our proactive approach ensures compliance with evolving CDSCO standards and minimizes time-to-market.
Getting Started with Your CDSCO License Application
- Confirm Device Classification: Double-check your device class and risk categorization.
- Initiate Test License Application (MD13): Submit early through the CDSCO MD Online Portal.
- Prepare Technical Documentation: Use our detailed guides on Device Master File and Plant Master File to assemble your dossier.
- Select a Notified Body: Schedule your audit with an accredited body.
- Plan for Product Testing: Book slots at CDSCO-recognized labs.
- Submit MD5 License Application (Form MD3): Once test results and audit are ready, apply online.
- Engage Expert Support: Consider partnering with experienced regulatory consultants to navigate complexities.
By following these structured steps tailored for Plastic Surgery Osteotomes, manufacturers and importers can confidently enter the Indian market with full regulatory compliance. Our 25+ years of industry experience and proven track record empower you to achieve licensing success efficiently and effectively.
