CDSCO License for Anaesthesia Facemask, single use (paediatric)
Medical Device Information
Intended Use
A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. It may be stabilized with a headstrap. It is constructed of nonwoven materials such as conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 15 mm connector (paediatric), and is available in a range of sizes. This device is sometimes used in association with a manual resuscitator. It is a single use, disposable device that is provided non-sterile.
Comprehensive Guide to CDSCO Licensing for Anaesthesia Facemask (Single Use, Paediatric)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized products like the paediatric single-use anaesthesia facemask. As a trusted regulatory consultancy with over 25 years of experience and having assisted 500+ manufacturers and importers, we provide you with expert, step-by-step guidance on securing your CDSCO license efficiently and compliantly.
Understanding Your Device and Its Regulatory Importance
The anaesthesia facemask (single use, paediatric) is a Class B medical device under CDSCO’s risk classification. This device plays a critical role in pediatric and neonatology care by providing a safe and effective means to deliver anaesthetic gases while acting as a barrier against microorganisms and particulates. Given its direct contact with the patient’s respiratory tract and role in anaesthesia administration, stringent regulatory compliance ensures safety, efficacy, and quality.
CDSCO Regulatory Framework for Paediatric Anaesthesia Facemask
The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. For Class B devices such as your anaesthesia facemask, the licensing process is managed by the State Licensing Authority and involves obtaining an MD5 Manufacturing License.
Your device falls under the pediatrics and neonatology category, making compliance with specific standards and documentation mandatory.
Risk Classification and License Requirements for Class B Devices
Class B devices are considered low to moderate risk. The licensing requirements, therefore, focus on ensuring manufacturing processes meet quality standards, supported by required documentation and product testing.
- License Type: MD5 (Manufacturing License for Class A & B devices)
- Authority: State Licensing Authority
- Application Form: MD3
- Total Timeline: Approximately 3-4 months (including test license and audit)
- Fees: ₹5,000 per application + ₹500 per product
For detailed classification, visit our Medical Device Classification guide.
Step-by-Step Manufacturing License Process (MD5) for Anaesthesia Facemask
Obtain Test License (Form MD13):
- Duration: 1.5 to 2 months
- Allows you to manufacture the device for testing purposes.
Product Testing:
- Conduct testing at CDSCO-approved government laboratories.
- Refer to the Testing Laboratories list to identify authorized labs.
Document Preparation:
- Assemble all required documents including Device Master File, Plant Master File, Risk Management File, and more.
Submit Application (Form MD3) for MD5 License:
- Use the CDSCO MD Online Portal for application submission.
Audit by Notified Body:
- The notified body conducts a thorough audit of your manufacturing site.
- Find a suitable auditor from the Notified Bodies List.
Resolve Queries:
- Address any observations or queries raised by the department or notified body promptly.
Grant of MD5 License:
- Upon satisfactory compliance, the license is granted on Form MD5.
For more detailed insights, our MD5 License guide is an excellent resource.
Manufacturing License Documents Required for Anaesthesia Facemask
- Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association.
- Proof of Ownership or Lease of Manufacturing Premises: Rent agreement or sale deed.
- Technical Staff Qualifications: CVs and qualification certificates of technical personnel.
- Fire NOC & Pollution Control Certificate: Mandatory clearances from respective authorities.
- Device Master File (DMF): Detailed device description, specifications, manufacturing process. Refer to our Device Master File guide.
- Plant Master File (PMF): Details about the manufacturing facility per our Plant Master File guide.
- Essential Principles Checklist: Compliance with Indian Medical Device Rules and ISO 13485 requirements.
- Risk Management File: Documentation of hazard analysis and mitigation strategies (see our Risk Management guide).
- Test Reports: From CDSCO-approved labs.
- Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
- Quality Management System (QMS) Documents: ISO 13485 certification and supporting procedures.
Import License Process (MD15) for Anaesthesia Facemask
If you plan to import the anaesthesia facemask, an MD15 Import License issued by the Central Licensing Authority is mandatory.
- Application Form: MD14
- Timeline: 5-6 months
- Fees: Vary by device class; for Class B devices approximately ₹2,000 per site + ₹1,000 per product
- Documents Required:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device and Plant Master Files
- Wholesale License
- Company Constitution Documents
The Import License guide offers detailed procedural information.
Timeline and Processing Duration
| Process Step | Estimated Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 3 weeks |
| MD5 License Application | 1 week (submission) |
| Audit by Notified Body | 4 - 6 weeks |
| Query Resolution | 2 - 3 weeks |
| License Grant | Within 1 week post audit |
Total Time: Approximately 3-4 months from start to finish.
Government Fees and Costs Breakdown
| Fee Type | Amount (INR) |
|---|---|
| Test License Fee | Included in application |
| MD5 Manufacturing Fee | ₹5,000 per application |
| Product Fee | ₹500 per product |
| Audit Fees | Typically borne by applicant; varies by notified body |
Budgeting for these fees early in your project timeline is essential to prevent delays.
Common Challenges and Solutions in CDSCO Licensing
- Incomplete Documentation: Missing or improperly formatted documents cause major delays. Solution: Rely on expert review and standardized templates.
- Delayed Product Testing: Limited slots at government labs can bottleneck testing. Solution: Schedule tests early and consider batch testing.
- Audit Non-Compliance: Audit observations on facility or QMS gaps. Solution: Conduct internal pre-audits and corrective action plans.
- Query Resolution Delays: Slow responses increase overall timeline. Solution: Assign dedicated regulatory personnel for prompt correspondence.
Expert Consultation and Support
Our proven track record with over 500 successful CDSCO license approvals enables us to anticipate and mitigate regulatory hurdles. We offer:
- Customized gap analysis for your manufacturing setup
- End-to-end document preparation and review
- Liaison with CDSCO officials and notified bodies
- Training on compliance and audit readiness
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your anaesthesia facemask is Class B under CDSCO MDR.
- Plan Your Testing Strategy: Book slots at approved testing labs early.
- Prepare Comprehensive Documentation: Utilize our Device Master File and Plant Master File guides.
- Submit Test License Application: Through the CDSCO MD Online Portal.
- Engage a Notified Body Early: Select from the Notified Bodies List to schedule your audit.
- Maintain Open Communication: Track application status regularly and respond swiftly to queries.
By following this roadmap and leveraging our expertise, manufacturers and importers can achieve timely and compliant market entry for their paediatric anaesthesia facemasks. Contact us today to begin your CDSCO licensing journey with confidence.
