CDSCO License for Dermatome skin approximation tape
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 tape that comes in various sizes with adhesive on both sides. It is attached onto a skin graft knife to collect a skin graft tissue. This device is for single- use.
Introduction to Dermatome Skin Approximation Tape and Regulatory Importance
Dermatome skin approximation tape is a crucial single-use medical device designed for dermatological and plastic surgery applications. Specifically, this double-sided adhesive tape is attached to a skin graft knife, facilitating the collection of skin graft tissue with precision and care. Given its direct role in surgical procedures, regulatory compliance is paramount to ensure patient safety and product efficacy.
In India, regulatory oversight for this device falls under the Central Drugs Standard Control Organization (CDSCO), governed by Notification 29/Misc./03/2020-DC (147), dated 26.7.2021. For manufacturers and importers, obtaining the correct CDSCO license is not just a legal formality but a critical step to access the growing Indian market confidently.
CDSCO Regulatory Framework for Dermatome Skin Approximation Tape
As a Class A medical device, dermatome skin approximation tape is categorized as low risk under the Indian regulatory system. This classification dictates the license type, documentation, and authority responsible for granting the manufacturing or import license.
The CDSCO framework mandates that Class A devices obtain the MD5 manufacturing license granted by the State Licensing Authority. Importers must secure the MD15 import license from the Central Licensing Authority. Both licenses ensure compliance with Indian regulations, including quality management, safety, and performance standards.
Risk Classification and License Requirements for Dermatome Skin Approximation Tape
- Risk Class: A (Low Risk)
- License Required: MD5 Manufacturing License (Form MD3) for local manufacturing
- Authority: State Licensing Authority
- Import License: MD15 (Form MD14) granted by Central Licensing Authority
This classification simplifies the regulatory pathway compared to higher-risk devices but still involves stringent documentation, testing, and audit processes to uphold standards.
Manufacturing License Process (MD5) for Dermatome Skin Approximation Tape
The MD5 license process involves multiple steps, each critical for ensuring compliance:
Test License (Form MD13): Initially, manufacturers must obtain a test license, which takes approximately 1.5 to 2 months. This allows for product testing and validation.
Product Testing: Conducted at CDSCO-approved testing laboratories to verify safety and performance. For a list of approved testing laboratories, manufacturers can refer to the CDSCO portal.
Document Preparation: Assemble all required documentation, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, and Risk Management File.
Application Submission: Submit the manufacturing license application via Form MD3 on the CDSCO MD Online Portal.
Audit by Notified Body: A compliance audit by a notified body is mandatory. Manufacturers should consult the list of notified bodies to identify an authorized auditor.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
Grant of License: Upon satisfactory audit and documentation review, the State Licensing Authority issues the MD5 license.
Total time for the entire MD5 process averages 3 to 4 months.
Manufacturing License Documents Required for Dermatome Skin Approximation Tape
Manufacturers must prepare and submit comprehensive documentation, including but not limited to:
- Company constitution and incorporation documents
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and pollution clearance certificates
- Device Master File (DMF) detailing device design and specifications (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing environment and facilities (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with Indian regulations
- Risk Management File demonstrating risk assessment and mitigation (Risk Management)
- Product test reports from approved laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485 certified
Practical Tip: Early preparation of Device and Plant Master Files can significantly reduce application delays.
Import License Process (MD15) for Dermatome Skin Approximation Tape
For importers of dermatome skin approximation tape into India, the MD15 license is mandatory:
Document Preparation: Gather necessary documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), DMF, PMF, wholesale license, and company constitution.
Application Submission: Submit the MD15 application using Form MD14 via the CDSCO MD Online Portal.
Query Resolution: Respond promptly to any queries from the Central Licensing Authority.
License Grant: Upon successful review, the MD15 import license is granted.
Import license processing takes approximately 5 to 6 months. Unlike manufacturing licenses, test license and product testing are not mandatory for imports but having robust documentation accelerates approval.
Import License Documents Required for Dermatome Skin Approximation Tape
- Valid manufacturing license from the country of origin
- Free Sale Certificate (FSC)
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale drug license for import and distribution
- Company constitution and incorporation proof
Ensuring all documents are current and correctly certified is essential to prevent delays.
Timeline and Processing Duration
| License Type | Process Steps | Duration |
|---|---|---|
| MD5 Manufacturing | Test License (1.5-2 months) + Audit + Queries | 3-4 months total |
| MD15 Import License | Document review + Queries + Approval | 5-6 months total |
Planning your project timeline in advance with buffer periods for audit scheduling and query resolution is advisable.
Government Fees and Costs for Dermatome Skin Approximation Tape
- MD5 License: Application fee Rs 5,000 + Rs 500 per product
- MD15 Import License:
- Class A Devices: 50 per product
Manufacturers should budget not only for government fees but also for notified body audits, product testing, and document preparation.
Common Challenges and Solutions
- Delayed Testing Reports: Choose CDSCO-approved testing labs with efficient turnaround times. Early booking of test slots can avoid delays.
- Incomplete Documentation: Utilize expert regulatory consultants to review your DMF and PMF against CDSCO checklists.
- Audit Scheduling Conflicts: Engage notified bodies early to schedule audits; maintaining a good relationship expedites the process.
- Query Resolution Delays: Assign a dedicated regulatory point person for prompt communication with CDSCO authorities.
Real-world Insight: We helped a leading skin care device manufacturer reduce license approval time by 30% by preemptively addressing audit non-conformities and ensuring lab testing was completed before application submission.
Expert Consultation and Support
With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we provide end-to-end regulatory support—from documentation to audit facilitation. Our expertise extends to:
- Preparing Device and Plant Master Files tailored for dermatome skin approximation tape
- Navigating audit processes with notified bodies
- Liaising with CDSCO for swift query resolution
- Advising on quality management and risk assessments
Partnering with seasoned consultants can transform a complex licensing journey into a streamlined, successful market entry.
Getting Started with Your CDSCO License Application for Dermatome Skin Approximation Tape
- Determine Your Licensing Needs: Confirm whether you require a manufacturing (MD5) or import (MD15) license.
- Register on CDSCO MD Online Portal: All applications must be submitted electronically via the CDSCO MD Online Portal.
- Prepare Essential Documents: Begin compiling your Device Master File, Plant Master File, and other mandatory documents early.
- Engage Testing Laboratories: Schedule your product testing at CDSCO-approved labs to avoid bottlenecks.
- Select a Notified Body: Identify and coordinate with a notified body for your audit from the official list of notified bodies.
- Submit Test License Application (if manufacturing): Apply for the test license (Form MD13) to initiate product testing.
- Maintain Clear Communication: Assign a dedicated person to monitor application status and respond to authority queries promptly.
Taking these proactive steps will help streamline your CDSCO license application and ensure timely market access for your dermatome skin approximation tape.
For detailed guidance and personalized assistance, reach out to our regulatory consulting team with 25+ years of proven success in navigating India's medical device regulatory landscape.
