CDSCO License for Patient care reverse isolation chamber.

Comprehensive CDSCO Licensing Guide for Patient Care Reverse Isolation Chambers (Class B)

As a vital medical device designed to protect immunocompromised patients—such as those undergoing burn treatment or suffering from congenital immunodeficiencies—the Patient Care Reverse Isolation Chamber falls under Class B risk classification. Classified under General Hospital or Orthopaedic Instruments and notified as per 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, this device requires a meticulous approach to obtain the necessary license from the Central Drugs Standard Control Organization (CDSCO).

With over 25 years of experience helping more than 500 companies successfully navigate CDSCO licensing, we understand the unique challenges manufacturers and importers face. Below is a detailed breakdown of the regulatory framework, step-by-step license application process, timelines, fees, and practical tips specific to Patient Care Reverse Isolation Chambers.

CDSCO Regulatory Framework for Patient Care Reverse Isolation Chambers

The CDSCO regulates medical devices based on their risk class. Your device, categorized as Class B (low to moderate risk), requires a manufacturing license through the State Licensing Authority via the MD5 license pathway. Importers apply through the Central Licensing Authority for an MD15 import license.

Compliance with the Medical Device Rules, 2017, along with adherence to essential principles for safety and performance, is mandatory. The device must also meet quality management standards such as ISO 13485:2016.

Risk Classification and License Requirements

• Risk Class: B (Low to moderate risk)
• License Type for Manufacturing: MD5 (Form MD3 application)
• Issuing Authority: State Licensing Authority
• License for Import: MD15 (Form MD14 application) via Central Licensing Authority

Class B devices require a test license (MD13) before the manufacturing license application, product testing in government-approved labs, followed by an audit from a notified body.

Manufacturing License Process (MD5)

Step 1: Obtain Test License (Form MD13)

• Purpose: Allows sample testing of your product in CDSCO-approved laboratories.
• Timeline: Approximately 1.5 to 2 months.

Step 2: Product Testing

• Conduct comprehensive testing in government-approved labs listed on the CDSCO Testing Laboratories page.
• Testing confirms the device complies with safety, performance, and quality requirements.

Step 3: Prepare Documentation

• Assemble all technical and quality-related documents, including Device Master File and Plant Master File.

Step 4: Submit Manufacturing License Application (Form MD3)

• Apply through the CDSCO MD Online Portal.
• Include required documents and fees.

Step 5: Audit by Notified Body

• A notified body from the CDSCO Notified Bodies List will audit your manufacturing facility.

Step 6: Address Queries and Obtain License

• Respond promptly to any queries from CDSCO or the notified body.
• Upon satisfactory review, the license on Form MD5 will be granted.

For a detailed guide, refer to our MD5 License Guide.

Manufacturing License Documents Required for Patient Care Reverse Isolation Chambers

• Company constitution and incorporation documents
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, manufacturing, and quality controls (See our DMF guide)
• Plant Master File (PMF) outlining manufacturing site details (Learn more about PMF)
• Essential Principles Compliance Checklist
• Risk Management File documenting hazard analysis and mitigation strategies (Risk Management guidance)
• Test reports from certified laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15)

Step 1: Document Preparation

• Collect all import-related documents including manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, DMF, PMF, and wholesale license.

Step 2: Submit Application (Form MD14)

• Apply via the CDSCO MD Online Portal.

Step 3: Query Resolution

• Promptly address any CDSCO queries.

Step 4: License Grant

• Upon approval, MD15 license is issued enabling import of the Patient Care Reverse Isolation Chamber.

Detailed import guidance is available in our Import License Guide.

Import License Documents Required

• Valid manufacturing license (MD5 or MD9)
• Free Sale Certificate from country of origin
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale drug license
• Company incorporation documents

Timeline and Processing Duration

Note: Delays often occur due to incomplete documentation or slow query responses.

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Fees included in application process
• MD15 Import License:
  • Class B Devices: Rs 2,000 per site + Rs 1,000 per product

Budget for additional costs such as notified body audits, lab testing, and consultancy fees.

Common Challenges and Solutions

• Incomplete Documentation: Thoroughly review document checklists; seek expert consultation to avoid rejections.
• Delayed Testing: Engage with CDSCO-approved labs early to schedule tests and avoid bottlenecks.
• Audit Non-Conformities: Prepare your manufacturing site and QMS for notified body audits by conducting internal audits first.
• Regulatory Updates: Keep abreast of CDSCO notifications and amendments to ensure ongoing compliance.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like Patient Care Reverse Isolation Chambers. Our regulatory consultants have guided 500+ companies through this process, helping reduce timelines and mitigate audit risks.

We offer:

• End-to-end license application support
• Document preparation and review
• Internal audits and gap analysis
• Training on regulatory requirements

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your device is Class B using the Medical Device Classification resource.
2. Compile documentation: Begin assembling your Device Master File and Plant Master File.
3. Apply for the Test License (MD13): Submit the test license application via the CDSCO MD Online Portal.
4. Schedule product testing: Coordinate with approved testing laboratories early.
5. Prepare for audit: Choose a notified body from the official list and conduct internal readiness audits.
6. Submit manufacturing license application (MD5): Complete and submit Form MD3 with all supporting documents.
7. Maintain communication: Respond promptly to any queries from CDSCO or auditors.

By following these actionable steps and leveraging our expertise, manufacturers and importers can confidently bring Patient Care Reverse Isolation Chambers to the Indian market with a compliant CDSCO license.

For personalized support, reach out to us today and safeguard your regulatory success.