CDSCO License for Static magnetic anal plug
Medical Device Information
Intended Use
A non-sterile magnetic device designed to be inserted into the rectum by the user and retained there for a specified period of time (e.g., 1 to 2 hours per day for 10 to 20 days) to help reduce anal haemorrhoids with magnetism.

Comprehensive Guide to CDSCO Licensing for Static Magnetic Anal Plug (Class B Medical Device)
As specialists with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the nuances involved in bringing innovative medical devices like the static magnetic anal plug to the Indian market. This device, categorized in gastroenterology, is a Class B medical device designed for non-sterile use to alleviate anal haemorrhoids through magnetism. Navigating the regulatory framework effectively ensures not only compliance but also smooth market entry.
CDSCO Regulatory Framework for Static Magnetic Anal Plug
The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Given the device’s classification as Class B, the regulatory pathway involves obtaining a manufacturing license under Form MD5, granted by the State Licensing Authority. This pathway ensures that safety, quality, and performance standards are rigorously met before the device reaches users.
Manufacturers must also comply with essential documentation requirements such as Device Master File (DMF), Plant Master File (PMF), and Risk Management File aligned with the MDR. These documents collectively demonstrate compliance with quality and safety norms.
Risk Classification and License Requirements for Static Magnetic Anal Plug
The static magnetic anal plug falls under Risk Class B, which typically includes devices with low to moderate risk. This classification mandates:
- Obtaining a Manufacturing License (MD5) via application Form MD3.
- Conducting product testing through CDSCO-approved laboratories.
- Undergoing an audit by a notified body listed by CDSCO.
For detailed classification guidance, you can visit our Medical Device Classification resource.
Manufacturing License Process (MD5) for Class B Medical Devices
The MD5 license process involves several critical steps:
- Test License Application (Form MD13): Before full license application, manufacturers must obtain a test license, which permits manufacturing trial batches.
- Product Testing: Conduct testing at government-approved labs to verify safety and performance.
- Document Preparation: Compile all technical and regulatory documentation.
- License Application Submission: Apply online using Form MD3 through the CDSCO MD Online Portal.
- Audit by Notified Body: Undergo inspection by a CDSCO-recognized notified body. Check the list of notified bodies for audit arrangements.
- Query Resolution: Address any queries from CDSCO or the notified body promptly.
- License Grant: Upon satisfactory review, receive the MD5 manufacturing license.
Manufacturing License Documents Required for Static Magnetic Anal Plug
For a Class B device like the static magnetic anal plug, the following documents are mandatory:
- Company Constitution (e.g., Memorandum of Association)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Detailed technical specifications and design details (Learn more about DMFs)
- Plant Master File (PMF): Manufacturing environment and processes documentation (Plant Master File guide)
- Essential Principles Checklist demonstrating compliance with MDR
- Risk Management File specific to the device's magnetic mechanism (Risk Management insights)
- Test reports from approved laboratories (Testing Laboratories)
- Product labeling including Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process (MD15) for Static Magnetic Anal Plug
If you are importing the static magnetic anal plug into India, the MD15 import license granted by the CDSCO Central Licensing Authority is mandatory. The process includes:
- Document preparation including valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files.
- Application submission via Form MD14 on the CDSCO MD Online Portal.
- Addressing departmental queries.
- License issuance on Form MD15.
The process can take 5-6 months, given the thorough scrutiny involved.
Import License Documents Required
For importers, ensure to prepare:
- Valid manufacturing license issued by the foreign competent authority
- Free Sale Certificate or equivalent
- ISO 13485:2016 certification and CE Mark (if applicable)
- Device Master File and Plant Master File
- Wholesale License for distribution
- Company Constitution documents
Timeline and Processing Duration
License Type | Duration |
---|---|
Test License (MD13) | 1.5 to 2 months |
MD5 Manufacturing License | 3 to 4 months (including audit and query resolution) |
MD15 Import License | 5 to 6 months |
Manufacturers should plan for approximately 3-4 months to achieve full manufacturing license approval for the static magnetic anal plug. Early initiation of product testing and document preparation can significantly reduce delays.
Government Fees and Costs
For Class B devices like the static magnetic anal plug, the fees are:
- Test License (MD13): No separate fee, included in manufacturing license process
- Manufacturing License (MD5): Rs 5,000 per application + Rs 500 per product
These fees are payable online through the CDSCO portal. Budgeting for additional costs such as notified body audit charges and testing fees is essential. Audits and testing can add Rs 50,000 to Rs 1,00,000 depending on scope.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Testing at government-approved labs can be time-consuming due to backlog.
- Solution: Engage with labs early, submit complete samples, and consider parallel document preparation.
Challenge 2: Incomplete Documentation Leading to Queries
- Missing or inconsistent Device Master File details are a common cause.
- Solution: Utilize expert consultants to prepare and review documents thoroughly.
Challenge 3: Audit Non-Compliance
- Not meeting GMP or QMS requirements can cause audit failures.
- Solution: Pre-audit readiness assessments and training for staff ensure compliance.
Expert Consultation and Support
With our extensive track record advising over 500 companies, we provide end-to-end regulatory support:
- Preparing customized Device and Plant Master Files
- Coordinating testing with CDSCO-approved labs
- Liaising with notified bodies and CDSCO officials
- Handling application submission and query resolution
Our practical insights help reduce approval timelines and avoid costly rework.
Getting Started with Your CDSCO License Application for Static Magnetic Anal Plug
- Register on the CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
- Prepare Essential Documentation: Begin compiling your Device Master File and Plant Master File promptly.
- Apply for Test License (MD13): Submit an application to initiate manufacturing trials.
- Plan Product Testing: Schedule testing with a government-approved laboratory to ensure compliance.
- Engage a Notified Body Early: Familiarize with audit requirements via the Notified Bodies List.
- Submit Manufacturing License Application (Form MD3): After successful testing and test license period.
- Prepare for Audit and Query Resolution: Address any feedback quickly to expedite license grant.
By following these precise steps and leveraging expert support, manufacturers of the static magnetic anal plug can efficiently navigate the CDSCO regulatory landscape and successfully enter the Indian market.
For detailed guidance on each step, explore our dedicated resources on MD5 License Guide.
We invite you to connect with us to discuss your project requirements and ensure a hassle-free licensing journey for your static magnetic anal plug device.