CDSCO License for Microlaryngeal probe
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 hand-held manual surgical instrument designed for paediatric laryngology and for phonatory microsurgery applications in adults. This delicate probe gives a precise sense of palpation for accurate detection of induration, tissue mass, and cystic changes. It is also used to break thick mucus fluid before its extraction. This is a reusable device.
Comprehensive CDSCO Licensing Guide for Microlaryngeal Probe (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience, having successfully supported 500+ companies in securing CDSCO licenses, we understand the nuances and critical compliance requirements for medical devices like the Microlaryngeal Probe. This hand-held, reusable surgical instrument designed for paediatric laryngology and phonatory microsurgery falls under Class A - the lowest risk category. However, meticulous adherence to the regulatory framework is essential for timely market entry in India.
Understanding the Microlaryngeal Probe and Its Regulatory Significance
The Microlaryngeal Probe is a delicate device used to palpate tissues with precision, detect abnormalities such as indurations and cystic changes, and assist in mucus fluid management during surgeries. It is classified under Pediatrics and Neonatology and notified under File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021. Given its reuse and surgical nature, regulatory compliance ensures safety, efficacy, and quality for vulnerable patient groups.
CDSCO Regulatory Framework for Microlaryngeal Probes
In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The framework mandates licensing for manufacturing and importing based on risk classification. The Microlaryngeal Probe, being a Class A device, requires a state-level manufacturing license (MD5) and import license (MD15) if applicable.
Risk Classification and License Requirements for Class A Devices
Class A devices are considered low risk and are governed by the State Licensing Authority for manufacturing licenses. For the Microlaryngeal Probe, the following applies:
- Manufacturing License: MD5 License (Application Form MD3)
- Import License (if applicable): MD15 License
You can explore device classification details on our Medical Device Classification guide.
Step-by-Step Manufacturing License Process (MD5) for Microlaryngeal Probe
Apply for Test License (Form MD13): Before applying for the MD5 license, you must obtain a test license to conduct product testing. This takes roughly 1.5 to 2 months.
Product Testing: Get the Microlaryngeal Probe tested at CDSCO-approved testing laboratories to verify conformity with Indian standards. Refer to the Testing Laboratories list.
Document Preparation: Compile all regulatory documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File. Our detailed Device Master File Guide and Plant Master File Guide can assist you in preparation.
Application Submission: File the MD5 license application using Form MD3 through the CDSCO MD Online Portal.
Audit by Notified Body: Your manufacturing facility will undergo an audit by a CDSCO-notified body. Check the Notified Bodies List for authorized auditors.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant: Upon satisfactory audit and document review, the MD5 manufacturing license is issued.
Essential Documents Required for MD5 License Application
- Company Constitution and Incorporation Certificates
- Proof of Premises Ownership or Lease
- Technical Staff Qualification and Experience Documents
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) covering design and specifications
- Plant Master File (PMF) detailing manufacturing facility
- Essential Principles Compliance Checklist
- Risk Management File specific to Microlaryngeal Probe
- Test Reports from approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents
Import License Process (MD15) for Microlaryngeal Probe
If you plan to import the Microlaryngeal Probe into India, you must obtain an MD15 import license issued by the Central Licensing Authority. The process is as follows:
Document Preparation: Collect required documents such as Manufacturing License of foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.
Application Submission: Apply using Form MD14 via the CDSCO MD Online Portal.
Query Resolution: Respond to any queries raised by the CDSCO authorities.
License Issuance: After all compliance checks, the MD15 license is granted.
Documents Required for MD15 Import License
- Foreign Manufacturer’s Manufacturing License
- Free Sale Certificate from country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License of Importer
- Company Constitution and Corporate Documents
Timelines and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| MD5 Manufacturing | 3 – 4 months total |
| MD15 Import License | 5 – 6 months |
The MD5 license timeline includes test license approval, product testing, document submission, audit, and license grant.
Government Fees and Costs Breakdown
MD5 Manufacturing License:
- Application Fee: Rs 5,000
- Per Product Fee: Rs 500 (per product)
Test License (MD13): Fees as specified by CDSCO at application
MD15 Import License:
- Class A Device (Microlaryngeal Probe) Fees:
- Site Fee: $1000
- Per Product Fee: $50
- Class A Device (Microlaryngeal Probe) Fees:
Always verify the latest fee structure on the CDSCO portal to avoid discrepancies.
Common Challenges and Practical Solutions
Delayed Product Testing: Testing lab backlogs can slow the process. We recommend early booking of test slots at certified labs.
Incomplete Documentation: Missing or improperly formatted Device Master Files or Risk Management Files often trigger queries. Utilize our stepwise guides to ensure completeness.
Audit Preparedness: Non-compliance during notified body audits can cause rejections. Conduct internal mock audits prior to official inspections.
Query Resolution Delays: Respond promptly with complete evidence to avoid prolonged processing.
Expert Consultation and Support for Smooth Licensing
Navigating the regulatory maze can be daunting. Our expertise spans the entire CDSCO application lifecycle—from test license acquisition to audit preparation and final license grant. We provide:
- Customized documentation support tailored for the Microlaryngeal Probe
- Liaison with testing labs and notified bodies
- Timely updates on regulatory amendments
- Hands-on assistance in portal application submission via CDSCO MD Online Portal
Getting Started with Your CDSCO License Application for Microlaryngeal Probe
- Assess Device Classification: Confirm Class A status and licensing requirements.
- Initiate Test License Application (MD13): Prepare and submit documents early.
- Schedule Product Testing: Select an approved laboratory from the CDSCO list.
- Compile Comprehensive Documentation: Leverage our Device Master File Guide and Plant Master File Guide for accuracy.
- Apply for Manufacturing License (MD5): Submit Form MD3 on the official portal.
- Prepare for Audit: Engage in pre-audit readiness activities.
- Address Queries Promptly: Maintain active communication with authorities.
Embarking on your CDSCO license journey with a clear roadmap and expert assistance will significantly enhance your approval success rate and time to market. Contact us to leverage our 25+ years of regulatory expertise in bringing your Microlaryngeal Probe to the Indian healthcare ecosystem.
