CDSCO License for Retractor
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
Handheld surgical device used to hold soft tissues retracted from the field of view. These include Self- Retaining Retractor,
Comprehensive Guide to CDSCO License for Retractors (Class A Medical Device)
Retractors are essential handheld surgical instruments designed to hold soft tissues away from the operative field, improving visibility and access during procedures. This includes specialized types like Self-Retaining Retractors, widely used in general hospital and orthopedic settings. Given their critical role, Retractors fall under Class A risk category as per CDSCO’s Medical Device Rules, 2017, notified under 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.
Understanding and complying with CDSCO’s regulatory framework is pivotal for manufacturers and importers aiming to introduce Retractors to the Indian healthcare market. With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide you with a detailed, step-by-step guide tailored specifically for Class A Retractors.
CDSCO Regulatory Framework for Retractors
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Retractors, classified as Class A (low risk), require a state-level manufacturing license (MD5) or an import license (MD15 for importers).
Since Retractors are categorized under General Hospital or Orthopaedic Instruments, they are regulated under the Medical Device Rules (MDR), 2017, with the latest notification dated 16.03.2022. Compliance ensures patient safety, product quality, and market acceptance.
For comprehensive classification details, manufacturers can refer to the Medical Device Classification guide.
Risk Classification and License Requirements for Retractors
| Device Name | Risk Class | License Type | Licensing Authority | Typical Timeline | Fees |
|---|---|---|---|---|---|
| Retractor (Handheld Surgical Device) | Class A | MD5 Manufacturing License (Form MD3) | State Licensing Authority | 3-4 months | Rs 5,000 + Rs 500 per product |
Class A devices like Retractors are considered low risk and are eligible for an MD5 license granted by the State Licensing Authority. This contrasts with higher-risk devices requiring central authority approval.
Manufacturing License Process for Retractors (MD5 License)
The MD5 license process for Class A Retractors involves several sequential steps:
Test License Application (Form MD13): Before manufacturing license, apply for a test license to manufacture the product for testing purposes. This typically takes 1.5 to 2 months for approval.
Product Testing: Get Retractors tested in government-approved laboratories for compliance with applicable standards. Refer to the list of CDSCO testing laboratories for authorized facilities.
Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, Quality Management System (QMS) documents, and others.
License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: The State Licensing Authority will coordinate an audit by a notified body listed here to verify compliance of manufacturing premises and processes.
Query Resolution: Address any queries raised by the authority or notified body promptly to avoid delays.
License Issuance (Form MD5): Upon successful audit and document review, the manufacturing license is granted.
For a detailed breakdown, you may consult our expert MD5 License Guide.
Manufacturing License Documents Required for Retractors
Accurate and complete documentation is crucial. For Retractors, expect to prepare and submit the following:
- Certificate of Incorporation and Company Constitution
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification Documents (e.g., Biomedical Engineer, Quality Manager)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process (See Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facilities (See Plant Master File Guide)
- Essential Principles Checklist
- Risk Management File (Risk Management Insights)
- Product Test Reports from CDSCO-approved labs
- Labels, Instructions for Use (IFU), and Packaging Details
- Quality Management System Documents (ISO 13485 compliance recommended)
We recommend early preparation of these files to streamline the application process.
Import License Process for Retractors (MD15 License)
For companies importing Retractors into India, the MD15 license issued by the Central Licensing Authority is mandatory. The process includes:
Document Compilation: Gather necessary documents such as valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
Application Submission: File the application on Form MD14 via the CDSCO MD Online Portal.
Query Handling: Respond effectively to any clarifications sought by CDSCO.
License Grant (Form MD15): Post satisfactory evaluation, CDSCO issues the import license.
Detailed guidance is available in our Import License Guide.
Import License Documents Required
- Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution and Address Proof
Timeline and Processing Duration
| Stage | Timeline |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months (concurrent with documentation) |
| Document Preparation | 2 - 3 weeks |
| License Application & Audit | 1 - 1.5 months |
| Query Resolution | 1 - 2 weeks |
| Total Time for MD5 License | Approximately 3-4 months |
Planning your timeline with these durations in mind helps avoid costly delays.
Government Fees and Costs
- MD5 Manufacturing License Application Fee: Rs 5,000 per application
- Per Product Fee: Rs 500
- Testing and Audit Fees: Varies depending on notified body and lab charges
Budgeting for these fees upfront ensures smooth financial planning.
Common Challenges and Practical Solutions
Challenge: Delays in test report approval due to laboratory backlogs.
Solution: Engage with multiple approved labs early and track sample submissions closely.
Challenge: Incomplete or inconsistent documentation causing audit non-compliance.
Solution: Utilize expert consultancy to review and pre-audit documentation before submission.
Challenge: Misunderstanding regulatory requirements specific to Retractors.
Solution: Stay updated with the latest notifications and consult the CDSCO MD Online Portal regularly.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially with evolving regulations. With our extensive experience in medical device regulatory compliance, we provide end-to-end support—from initial classification and documentation to audit readiness and license acquisition.
Our proven track record with 500+ successful licenses in Class A devices like Retractors means you benefit from practical insights, tailored guidance, and ongoing regulatory updates.
Getting Started with Your CDSCO License Application for Retractors
- Evaluate your product’s classification under current CDSCO rules to confirm the Class A status.
- Register on the CDSCO MD Online Portal to initiate your application process.
- Prepare comprehensive documentation including Device Master File and Plant Master File.
- Apply for the Test License (Form MD13) to begin manufacturing samples for testing.
- Coordinate with CDSCO-approved laboratories for product testing.
- Submit your Manufacturing License application (Form MD3) once test reports are ready.
- Schedule and prepare for the notified body audit ensuring full compliance of your manufacturing site.
- Respond promptly to any queries raised during the review process.
For personalized assistance, feel free to contact our regulatory experts who can help you navigate each step efficiently and cost-effectively.
Embark on your journey to market your Retractors in India with confidence backed by decades of regulatory expertise.
