CDSCO License for Absorbable perirectal spacer
Medical Device Information
Intended Use
An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum.
Introduction to Absorbable Perirectal Spacer and Regulatory Importance
An absorbable perirectal spacer is a critical medical device designed to protect the anterior rectal wall during prostate cancer radiotherapy by creating a temporary, biodegradable barrier. This innovative device significantly reduces radiation exposure to healthy tissues, improving patient outcomes. Given its specialized use in radiotherapy and associated patient safety considerations, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers aiming to enter the Indian market.
Understanding the regulatory landscape ensures seamless market access, avoids costly delays, and guarantees adherence to safety standards. With over 25 years of experience and having assisted more than 500 companies, we provide comprehensive consulting services to streamline your CDSCO licensing journey for absorbable perirectal spacers.
CDSCO Regulatory Framework for Absorbable Perirectal Spacer
Under the CDSCO framework, medical devices are regulated as per the Medical Device Rules 2017. Your device, categorized under radiotherapy devices, falls under the Class C risk category due to its invasive nature and critical role in patient safety.
The key regulatory steps include:
- Classification confirmation
- Test license acquisition (Form MD13)
- Product testing by government-approved labs
- Submission of manufacturing or import license application
- Compliance audits and inspections
This rigorous process ensures your device meets Indian safety, quality, and performance standards.
Risk Classification and License Requirements for Class C Device
Absorbable perirectal spacers are classified as Class C devices, indicating a moderate-to-high risk. Hence, the manufacturing license must be obtained from the Central Licensing Authority via the MD9 license process (Application Form MD7).
Key points for Class C devices:
- Licensing authority: Central Licensing Authority (CDSCO Headquarters)
- License type: MD9 Manufacturing License
- Test license required: Yes (Form MD13)
- Typical processing time: 4-5 months
- Fees: ₹50,000 per application + ₹1,000 per product
For importers, an MD15 Import License is required, involving a similar but distinct process.
Manufacturing License Process (MD9) for Absorbable Perirectal Spacer
The MD9 license process for Class C devices consists of multiple crucial stages:
Apply for Test License (Form MD13): Initiate the process by submitting Form MD13 for a test license, which typically takes 1.5 to 2 months to be granted. This allows you to legally manufacture the device for testing purposes.
Product Testing: Conduct mandatory testing at CDSCO-recognized laboratories. You can refer to the list of testing laboratories approved for medical device testing. Testing validates the device’s conformance with Indian standards.
Document Preparation: Compile comprehensive technical documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
MD9 License Application (Form MD7): Submit the application through the CDSCO MD Online Portal along with the required fees and documentation.
Inspection and Audit: CDSCO officials will conduct an onsite audit of your manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and QMS requirements.
Queries and Clarifications: Address any queries raised by the CDSCO or inspectors promptly to avoid delays.
License Grant: Upon successful review and audit completion, the MD9 Manufacturing License is granted.
Manufacturing License Documents Required for MD9
Accurate and complete documentation is critical. The following documents are required:
- Company constitution and registration certificates
- Proof of ownership or valid lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and pollution clearance certificates
- Device Master File (DMF) covering device design, manufacturing, and safety aspects. Our detailed Device Master File guide can assist in preparation.
- Plant Master File (PMF) documenting manufacturing facility details. Refer to our Plant Master File guide
- Essential Principles Checklist demonstrating compliance with Indian and international standards
- Risk Management File addressing hazards and mitigation strategies. For comprehensive risk protocols, see Risk Management
- Test reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 certification)
Import License Process (MD15) for Absorbable Perirectal Spacer
Importers of absorbable perirectal spacers must apply for an MD15 Import License through the Central Licensing Authority. The process involves:
Document Compilation: Prepare essential documents such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, wholesale license, and company constitution.
Application Submission: File Form MD14 via the CDSCO MD Online Portal.
Departmental Review: CDSCO reviews the application, raising queries if necessary.
License Issuance: Upon satisfactory review, the MD15 import license is granted.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate endorsing the device’s market availability
- ISO 13485:2016 certification
- CE Certificate or equivalent (for devices marketed in Europe)
- Device Master File
- Plant Master File
- Wholesale license
- Company constitution and registration proof
Timeline and Processing Duration
| Process Stage | Estimated Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | Varies (typically 1 month) |
| MD9 License Application | 4 - 5 months total including audit |
| Import License (MD15) | 5 - 6 months |
Planning for a total duration of approximately 4-5 months for manufacturing licensing and 5-6 months for import licensing is practical.
Government Fees and Costs
For a Class C absorbable perirectal spacer, the fee structure is as follows:
- MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product
- Test License (MD13): Nominal fees applicable as per CDSCO
- MD15 Import License: ₹3,000 per site + ₹1,500 per product
Additional costs to budget for include product testing fees at government-recognized laboratories and potential consultancy fees if external assistance is engaged.
Common Challenges and Solutions
Delays in Testing: Testing laboratories often have queues. Early booking with labs from the CDSCO Testing Laboratories list helps mitigate delays.
Incomplete Documentation: Missing or inconsistent documents are a frequent cause of query generation. Utilize our checklists and templates to ensure completeness.
Regulatory Updates: Keeping up with evolving regulations is vital. Engaging expert consultants or subscribing to CDSCO updates ensures compliance.
Audit Preparedness: Facility audits can be daunting. Conduct internal pre-audits and staff training to ensure readiness.
Expert Consultation and Support
With over 25 years in the regulatory domain, we have successfully guided 500+ companies through CDSCO licensing. Our expert services include:
- Gap analysis and compliance roadmap
- End-to-end document preparation including Device Master File and Plant Master File
- Test license and import/manufacturing license application filing
- Audit facilitation and query management
- Post-license regulatory support
Our practical insights ensure you avoid common pitfalls and expedite approval.
Getting Started with Your CDSCO License Application
Confirm Device Classification: Verify your absorbable perirectal spacer’s Class C status via the Medical Device Classification guide.
Initiate Test License Application: Prepare and submit Form MD13 for test license on the CDSCO MD Online Portal.
Book Testing Slots Early: Engage with notified testing labs to schedule product testing as soon as the test license is granted.
Compile Technical Documentation: Start assembling your Device Master File, Plant Master File, Risk Management File, and QMS documents.
Plan for Audit: Prepare your manufacturing facility as per CDSCO GMP guidelines and conduct internal audits.
Submit MD9 Application: Apply with Form MD7 on the CDSCO portal once test license and testing are complete.
Engage with Experts: Consider partnering with experienced consultants to navigate queries and expedite approvals.
Embarking on your CDSCO licensing journey with a clear, informed strategy will position your absorbable perirectal spacer for successful entry into the Indian healthcare market. Contact us to leverage our deep expertise and ensure a smooth and timely approval process.
