CDSCO License for Powered suction pump.

Introduction to Powered Suction Pump and Its Regulatory Importance

Powered suction pumps play a critical role in healthcare, especially in dermatological and plastic surgery settings. These devices, powered by AC or compressed air, effectively remove infectious materials or fluids from wounds and patients’ airways, enhancing surgical outcomes and patient safety. Given their vital function and direct patient contact, regulatory compliance is non-negotiable. For manufacturers and importers targeting the Indian market, securing the appropriate CDSCO license is essential to ensure legal marketing, patient safety, and product credibility.

With over 25 years of experience and having assisted more than 500 companies in navigating CDSCO regulations, we provide a detailed roadmap to obtain the MD5 manufacturing license for your Powered Suction Pump, classified as Risk Class B under Indian regulations.

CDSCO Regulatory Framework for Powered Suction Pump

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Powered suction pumps fall under the Dermatological & Plastic Surgery category and are notified under the gazette notification 29/Misc./03/2020-DC (147) dated 26.7.2021.

Classified as Risk Class B, these devices require compliance with the Medical Device Rules, 2017. Licensing is mandatory prior to manufacturing or import and involves a multi-step process including laboratory testing, documentation, and audits.

Risk Classification and License Requirements for Powered Suction Pump

Powered suction pumps are classified as Class B devices, indicating a moderate risk level. According to CDSCO:

Class A/B devices require an MD5 manufacturing license issued by the respective State Licensing Authority.
The process includes obtaining a test license (MD13), product testing at government-approved labs, documentation submission, audit by a notified body, and final license issuance.

For detailed classification guidance, refer to our Medical Device Classification resource.

Manufacturing License Process for Powered Suction Pump (MD5 License)

The MD5 license is mandatory for manufacturing Class B devices like powered suction pumps. The process can be broken down as follows:

Test License Application (Form MD13): Apply for a test license to legally manufacture the device prototype for testing purposes. This takes about 1.5–2 months.
Product Testing: Conduct testing at CDSCO-approved laboratories to verify compliance with essential principles and standards. See the list of testing laboratories for options.
Document Preparation: Compile all technical and quality documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit conducted by a notified body from the CDSCO list. Check the notified bodies list to appoint an auditor.
Queries and Clarifications: Address any queries raised during the audit or application review.
Grant of MD5 License: Upon successful completion, the State Licensing Authority issues the MD5 license on Form MD5.

The entire process spans approximately 3–4 months, including testing and audit.

Manufacturing License Documents Required for Powered Suction Pump

Accurate and thorough documentation is key to a smooth application. Required documents include:

Company Constitution (MOA and AOA)
Proof of ownership or lease agreement for manufacturing premises
Technical staff qualifications and experience documents
Fire No Objection Certificate (Fire NOC)
Pollution Control Board NOC
Device Master File (DMF) detailing device design and specifications (DMF Guide)
Plant Master File (PMF) describing manufacturing processes and facilities (PMF Guide)
Essential Principles Checklist demonstrating compliance
Risk Management File showing hazard analysis and mitigation (Risk Management)
Test Reports from CDSCO-approved labs
Product labels and Instructions for Use (IFU)
Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process for Powered Suction Pump (MD15 License)

For importers, the MD15 license issued by the Central Licensing Authority is required. The process involves:

Document Preparation: Unlike manufacturing, no test license is required. Collect documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
License Application (Form MD14): Submit the import license application on the CDSCO MD Online Portal.
Department Queries: Respond to any information requests.
Grant of MD15 License: The license is issued after satisfactory review, typically within 5–6 months.

Refer to our comprehensive Import License Guide for detailed steps.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate ensuring product legality
ISO 13485:2016 Certification
CE Certificate (if applicable)
Device Master File
Plant Master File
Wholesale License issued by State Authorities
Company Constitution documents

Timeline and Processing Duration

Process Step	Duration
Test License (MD13)	1.5 – 2 months
Product Testing	1 – 1.5 months
Documentation Prep	2 – 3 weeks
Application Submission	Immediate
Audit by Notified Body	3 – 4 weeks
Query Resolution	2 – 3 weeks
License Granting	Within 3-4 months

Import license processing typically takes 5–6 months.

Government Fees and Costs

For MD5 license (Class B device like powered suction pump):

Application Fee: Rs. 5,000
Per Product Fee: Rs. 500

Additional costs include:

Testing fees at government-approved labs (varies by test scope and lab)
Audit fees charged by notified bodies
Consultancy or documentation preparation costs (if outsourced)

Planning for these expenses in advance helps avoid unexpected delays.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Engage with CDSCO-approved labs early and ensure sample quality meets testing requirements.

Challenge 2: Incomplete Documentation

Solution: Use checklists and templates from experienced consultants to prepare comprehensive Device Master Files and Plant Master Files.

Challenge 3: Audit Non-compliance

Solution: Conduct internal mock audits and rectify gaps before the official notified body audit.

Challenge 4: Query Management

Solution: Respond promptly and thoroughly to CDSCO queries with supporting evidence.

Expert Consultation and Support

With over two decades of experience and a track record of enabling 500+ companies to secure CDSCO licenses, our expert team offers end-to-end support:

Gap analysis of your current documentation and processes
Assistance in test license and manufacturing license applications
Coordination with notified bodies and testing labs
Risk management and QMS implementation guidance
Post-license compliance monitoring

Our proactive approach ensures minimal delays and maximizes approval chances.

Getting Started with Your CDSCO License Application for Powered Suction Pump

To initiate your licensing journey, follow these practical steps:

Assess Device Classification: Confirm your device is Class B and requires MD5 license.
Register on the CDSCO MD Online Portal: Set up your company profile at the CDSCO MD Online Portal.
Prepare Test License Application: Compile preliminary documents and apply for the test license (Form MD13).
Select Testing Laboratory: Choose from the approved testing laboratories and schedule product testing.
Document Compilation: Begin preparing Device Master File, Plant Master File, Risk Management File, and QMS documents.
Plan for Notified Body Audit: Identify and liaise with a notified body from the approved list to schedule your audit.
Consult Experts: Engage regulatory consultants early to streamline preparation and submission.

By following this roadmap, your powered suction pump manufacturing license application will be well-positioned for timely approval, enabling market entry with confidence and compliance.

For further assistance, contact our regulatory experts who specialize in CDSCO licensing for medical devices.

CDSCO License for Powered suction pump.

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