CDSCO License for Surgical drape and drape accessories
Medical Device Information
Intended Use
A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination.
Comprehensive Guide to CDSCO Licensing for Surgical Drapes and Drape Accessories (Class B)
Surgical drapes and drape accessories play a critical role in ensuring sterile conditions during surgical procedures by isolating the surgical site from microbial contamination. As devices categorized under Dermatological & Plastic Surgery, these products are classified as Class B medical devices by the Central Drugs Standard Control Organization (CDSCO) in India. Given the importance of maintaining patient safety, obtaining the appropriate CDSCO licensing is mandatory for manufacturers and importers aiming to market surgical drapes in India.
With over 25 years of experience helping 500+ companies navigate the CDSCO regulatory framework, we bring you an expert-level overview tailored specifically to surgical drapes—covering every step from documentation to audit, timelines, and costs.
CDSCO Regulatory Framework for Surgical Drapes and Accessories
Surgical drapes fall under Class B medical devices according to the CDSCO classification, as outlined in Notification 29/Misc./03/2020-DC (147) dated 26.7.2021. The regulatory framework mandates compliance with the Medical Device Rules, 2017, and requires manufacturers to obtain a manufacturing license (MD5) issued by the State Licensing Authority.
Manufacturers must adhere to quality standards such as ISO 13485 and ensure their devices meet the Essential Principles checklist, including biocompatibility and sterility requirements. Compliance with risk management processes is equally vital to demonstrate control over potential hazards inherent in surgical drapes.
Risk Classification and License Requirements for Surgical Drapes
- Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Issuing Authority: State Licensing Authority
- Total Processing Time: Approximately 3 to 4 months
Class B devices like surgical drapes require a test license on Form MD13 before applying for the manufacturing license. This ensures the product undergoes necessary testing and quality verification.
Manufacturing License Process for Surgical Drapes (MD5)
The manufacturing license process involves several key phases:
- Test License Application (Form MD13): Obtain a test license to manufacture and test samples. This takes about 1.5 to 2 months.
- Product Testing: Conduct mandatory testing at CDSCO-approved government laboratories to validate device safety and performance. You can find the list of approved testing laboratories here.
- Document Preparation: Compile technical documentation including Device Master File, Plant Master File, Essential Principles checklist, and Risk Management File.
- Manufacturing License Application (Form MD3): Submit the application through the CDSCO MD Online Portal.
- Audit by Notified Body: Undergo an audit by a CDSCO-recognized notified body. The list of notified bodies is available here.
- Query Resolution: Respond promptly to any queries raised by the licensing authority or notified body.
- License Grant: Receive the MD5 license permitting commercial manufacturing.
Manufacturing License Documents Required
To ensure a smooth application, prepare the following documents meticulously:
- Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Qualification and Experience Certificates
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed product specifications, manufacturing process, and quality control procedures (Learn more about DMF)
- Plant Master File (PMF): Facility layout, equipment details, and quality systems (PMF Guide)
- Essential Principles Checklist: Compliance with safety and performance standards
- Risk Management File: Hazard analysis and mitigation strategies (Risk Management Best Practices)
- Test Reports from Approved Labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documentation (e.g., ISO 13485 certificate)
Import License Process for Surgical Drapes (MD15)
For importers looking to bring surgical drapes into India, an MD15 Import License is mandatory. The process is managed by the Central Licensing Authority and typically takes 5 to 6 months.
Steps include:
- Document Preparation: Compile all necessary certificates such as Free Sale Certificate, ISO 13485:2016, CE Certificate, along with Device and Plant Master Files.
- License Application (Form MD14): Submit application via the CDSCO MD Online Portal.
- Query Resolution: Address any departmental queries swiftly.
- License Grant: Obtain the Import License (Form MD15).
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or Equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | 2 to 3 weeks |
| Manufacturing License (MD5) Processing | 1 to 1.5 months |
| Total Time for MD5 License | 3 to 4 months |
| Import License (MD15) Processing | 5 to 6 months |
Government Fees and Costs
For surgical drapes (Class B), the fee structure is as follows:
- MD5 Manufacturing License:
- Application Fee: ₹5,000
- Per Product Fee: ₹500
- MD13 Test License:
- Included in initial application process
Costs for notified body audits and testing lab fees vary depending on scope and volume but typically range between ₹50,000 to ₹1,50,000.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Pre-book testing slots at government-approved labs and ensure samples meet submission criteria to avoid retesting.
Challenge 2: Incomplete Documentation
- Solution: Use detailed checklists and engage expert consultants to review files before submission.
Challenge 3: Audit Non-Compliance
- Solution: Conduct thorough internal audits against CDSCO standards and notified body requirements prior to official inspection.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory officer for prompt and clear communication with CDSCO.
Expert Consultation and Support
Our team has successfully guided over 500 medical device manufacturers and importers through the CDSCO licensing maze. From document preparation and test license procurement to audit readiness and timely query handling, we provide end-to-end support. Our expertise includes tailored solutions for Class B devices like surgical drapes, ensuring compliance with the latest regulatory updates.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class B using the Medical Device Classification tool.
- Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
- Plan Product Testing: Coordinate with approved labs early to avoid bottlenecks.
- Compile Documentation: Start assembling your Device Master File, Plant Master File, and other mandatory documents.
- Schedule Pre-Audit: Conduct internal audits and gap assessments.
- Submit Manufacturing License Application: Apply on the CDSCO portal using Form MD3.
- Prepare for Audit: Engage with a notified body and ensure compliance.
By following this structured approach and leveraging expert guidance, manufacturers and importers can significantly reduce approval timelines and ensure smooth entry of surgical drapes into the Indian market. For personalized assistance, reach out to our regulatory consultancy team to kick-start your CDSCO licensing journey with confidence.
