CDSCO License for Surgical Helmet
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
Intended to protect healthcare workers from contaminants & debris on head.
Comprehensive Guide to CDSCO Licensing for Surgical Helmets (Class A)
Surgical helmets are vital Personal Protective Equipment (PPE) designed to shield healthcare workers from contaminants and debris during surgical procedures. As a Class A medical device under the Indian regulatory framework, surgical helmets require compliance with specific CDSCO licensing mandates to ensure safety, quality, and market access.
Drawing from our 25+ years of experience supporting over 500 companies in successfully navigating CDSCO regulations, this guide unfolds the precise steps, documentation, timelines, and fees necessary to obtain the MD5 manufacturing license for surgical helmets.
Understanding the CDSCO Regulatory Framework for Surgical Helmets
The Central Drugs Standard Control Organization (CDSCO) classifies medical devices into four risk classes: A, B, C, and D. Surgical helmets fall under Class A, denoting low risk. Consequently, manufacturers must apply for an MD5 license, issued by the State Licensing Authority, to legally produce these devices in India.
The regulatory framework mandates adherence to the Medical Device Rules 2017, following the notification File No. 29/Misc./03/2020-DC (186) dated 13.9.2021, which specifically covers surgical helmets.
Risk Classification and License Requirements for Surgical Helmets
- Device Name: Surgical Helmet
- Risk Class: A (Low risk)
- Intended Use: Protect healthcare workers’ heads from contaminants and debris
- Category: Personal Protective Equipment (PPE)
- License Type: MD5 Manufacturing License
Class A devices like surgical helmets require compliance with essential principles, quality management systems, and testing before licensing.
The MD5 Manufacturing License Process for Surgical Helmets
The entire MD5 licensing process typically spans 3 to 4 months and includes the following stages:
Test License Application (Form MD13): Initially, apply for a test license, valid for 6 months, allowing product testing. This stage takes approximately 1.5 to 2 months.
Product Testing: Mandatory testing at CDSCO-approved laboratories (Testing Laboratories List) to verify compliance with applicable standards.
Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.
License Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: An audit conducted by a notified body from the Notified Bodies List assesses compliance with manufacturing and quality standards.
Query Resolution: Address any queries or deficiencies raised by the CDSCO or notified body.
Grant of MD5 License: Upon satisfactory review and audit, the State Licensing Authority issues the MD5 license.
Manufacturing License Documents Required for Surgical Helmets
Accurate and complete documentation accelerates approval. Key documents include:
- Company Constitution: Incorporation certificate, memorandum and articles of association.
- Proof of Ownership or Tenancy of Manufacturing Premises: Registered lease or ownership documents.
- Details of Technical Staff: Qualification and experience certificates.
- Fire Safety and Pollution Control NOCs: Valid certificates from local authorities.
- Device Master File (DMF): Detailed product specifications, design, manufacturing process (Device Master File Guide).
- Plant Master File (PMF): Facility layout, equipment details, and quality control systems (Plant Master File Guide).
- Essential Principles Checklist: Declaration of conformity with Indian Medical Device Rules.
- Risk Management File: Risk analysis and mitigation strategies following ISO 14971 principles (Risk Management Guide).
- Test Reports: From CDSCO-approved labs validating product performance and safety.
- Labels and Instructions for Use (IFU): Compliant with Indian regulations.
- Quality Management System Documents: ISO 13485:2016 certification and related SOPs.
Import License Process (MD15) for Surgical Helmets
For importers of surgical helmets, the MD15 license is mandatory and issued by the Central Licensing Authority. This process generally takes 5 to 6 months and requires documents such as:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device Master File and Plant Master File
- Wholesale drug license
- Company constitution and registration documents
Detailed guidance on import licensing is available in our Import License Guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| License Application (MD3) | Immediate submission post-prep |
| Notified Body Audit | 3 – 4 weeks |
| Query Resolution | 2 – 3 weeks |
| Total Estimated Time | 3 – 4 months |
Government Fees and Costs
- MD5 License Application Fee: Rs 5,000 per application
- Per Product Fee: Rs 500
- Test License Fee (Form MD13): Included in application process
- Testing Charges: Varies by lab; budget approximately Rs 50,000 – Rs 1,00,000 depending on test scope
- Notified Body Audit Fees: Charged separately by the notified body; ranges from Rs 50,000 to Rs 1,50,000
Budgeting accurately for these fees and associated consultancy or documentation preparation services avoids delays.
Common Challenges and Practical Solutions
Incomplete Documentation: Many applicants submit partial DMF or PMF files. Ensure all sections, including risk management and essential principles, are thoroughly compiled.
Delayed Testing: Prioritize scheduling tests with CDSCO-approved labs early to prevent bottlenecks.
Audit Non-Compliance: Prepare your facilities and QMS meticulously; pre-audit mock checks can identify gaps.
Query Management: Respond promptly and comprehensively to queries; use expert consultants to draft technical responses.
Our hands-on experience enables us to proactively tackle these hurdles, streamlining your path to license grant.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time manufacturers. Leveraging expert consultancy:
- Saves time by ensuring correct documentation
- Provides insights on regulatory updates
- Facilitates communication with CDSCO and notified bodies
- Helps implement robust QMS and risk management
Our team has successfully guided 500+ companies through this process, offering tailored solutions for surgical helmet manufacturers.
Getting Started with Your CDSCO License Application for Surgical Helmets
Register on the CDSCO MD Online Portal. This is mandatory for all submissions.
Initiate a Test License (MD13) application to allow product testing.
Engage with a CDSCO-approved testing laboratory early to schedule product testing.
Prepare comprehensive documentation including Device Master File, Plant Master File, risk management, and QMS documents.
Shortlist and appoint a notified body from the official Notified Bodies List for audit scheduling.
Maintain readiness for audit and queries by conducting internal reviews.
Submit the MD5 license application (Form MD3) via the portal once test reports and documents are ready.
Starting early, ensuring thorough preparation, and partnering with experienced consultants can dramatically accelerate your CDSCO licensing journey for surgical helmets. We invite you to contact us for personalized support and to leverage our proven expertise in India's medical device regulatory landscape.
