CDSCO License for Resorbable calcium salt bone void filler device
Medical Device Information
Intended Use
A resorbable calcium saltbone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis
Comprehensive Guide to CDSCO Licensing for Resorbable Calcium Salt Bone Void Filler Devices (Class C Orthopaedic Implants)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized implants like the resorbable calcium salt bone void filler device. This device, classified under risk Class C, is designed to fill bony voids or gaps in the extremities, spine, and pelvis, serving a critical role in orthopedic surgical procedures. With over 25 years of experience assisting 500+ companies in securing CDSCO licenses, we provide in-depth, actionable insights tailored to this device category.
CDSCO Regulatory Framework for Orthopaedic Implants: Resorbable Calcium Salt Bone Void Fillers
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. As per Notification 29/Misc/3/2017-DC (292) dated 06.06.2018, resorbable calcium salt bone void filler devices fall under orthopedic implants and are categorized as Class C devices due to their invasive nature and moderate to high risk to patients.
Manufacturers of Class C devices must obtain an MD9 manufacturing license from the Central Licensing Authority, while importers require an MD15 import license. Both licenses ensure compliance with quality, safety, and efficacy standards mandated by Indian law.
Risk Classification and License Requirements for Class C Devices
Class C devices, including your resorbable calcium salt bone void filler, require stringent regulatory oversight due to their implantable nature. Here’s what you need to know:
- Manufacturing License: MD9 (Application Form MD7), issued by CDSCO Central Licensing Authority.
- Import License: MD15 (Application Form MD14), also issued by CDSCO Central Licensing Authority.
- Test License: Mandatory MD13 test license before applying for manufacturing license.
Detailed timelines, fees, and documentation are outlined below to streamline your application process.
Manufacturing License Process (MD9) for Resorbable Calcium Salt Bone Void Filler Devices
The MD9 license process is comprehensive, reflecting the critical safety considerations of Class C devices.
- Test License (Form MD13): Initial step requiring application and approval for product testing.
- Product Testing: Conducted at CDSCO-approved government laboratories — essential to validate safety and compliance.
- Document Preparation: Assemble technical and quality documentation.
- Application Submission: Submit Form MD7 through the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: Inspection of manufacturing site, quality systems, and compliance.
- Query Resolution: Address any queries or deficiencies raised.
- Grant of License: Issuance of MD9 license (Form MD9).
The entire process typically takes 4-5 months, factoring in testing, audits, and regulatory reviews.
Manufacturing License Documents Required for MD9
Precise documentation is critical for approval. For your device, the following are essential:
- Company Constitution Documents: Proof of legal entity.
- Proof of Premises Ownership/Lease: Validated premises documentation.
- Technical Staff Credentials: Qualifications of personnel responsible for manufacturing.
- Fire and Pollution NOCs: Compliance with environmental and safety norms.
- Device Master File (DMF): Comprehensive technical dossier — refer to our Device Master File guide.
- Plant Master File (PMF): Details of manufacturing facilities — see our Plant Master File guide.
- Essential Principles Checklist: Device compliance matrix.
- Risk Management File: Evidence of risk assessment and mitigation strategies — our Risk Management resource offers practical tips.
- Test Reports: From CDSCO-approved labs.
- Labels and Instructions for Use (IFU): Device labeling and usage instructions.
- Quality Management System (QMS) Documents: ISO 13485:2016 compliance documentation.
Import License Process (MD15) for Resorbable Calcium Salt Bone Void Filler Devices
Importers looking to bring your Class C device into India must secure an MD15 license.
- No Test License Required: Unlike manufacturing, the test license is not mandatory.
- Document Preparation: Collate all required certifications and licenses.
- Application Submission: Apply via the CDSCO MD Online Portal.
- Query Resolution: Address any regulatory queries promptly.
- Grant of License: Issuance of MD15 license.
The process generally takes 5-6 months.
Import License Documents Required for MD15
Key documents include:
- Valid Manufacturing License (MD9 or equivalent from country of origin).
- Free Sale Certificate.
- ISO 13485:2016 Certification.
- CE Certificate or equivalent international certification.
- Device Master File and Plant Master File.
- Wholesale License.
- Company Constitution Documents.
Timeline and Processing Duration
| License Type | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Manufacturing License (MD9) | 4 - 5 months (includes testing & audit) |
| Import License (MD15) | 5 - 6 months |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 | Rs 50,000 | Rs 1,000 |
| MD15 (Class C) | USD 3,000 (approx Rs 2.5L) | USD 1,500 (approx Rs 1.25L) |
Note: Fees are payable online during application submission through the CDSCO portal.
Common Challenges and Solutions
- Delayed Testing Approvals: Partner with CDSCO-approved labs listed on the Testing Laboratories portal to expedite product testing.
- Incomplete Documentation: Utilize checklists and expert reviewers to ensure all files, especially DMF and PMF, are comprehensive.
- Audit Non-compliance: Pre-audit readiness assessments and training of technical staff help ensure smooth inspections.
- Query Resolution Delays: Maintain close communication with CDSCO and prepare detailed, prompt responses.
Expert Consultation and Support
With over two decades of regulatory consulting experience, we guide manufacturers and importers through every stage — from audit preparation to document drafting. For instance, our clients manufacturing orthopedic implants have successfully navigated the MD9 license process within 3.5 months by leveraging our document templates and audit readiness programs.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your device’s Class C status via the Medical Device Classification tool.
- Prepare Test License Application: Initiate Form MD13 submission through the CDSCO MD Online Portal.
- Engage CDSCO-Approved Testing Labs: Schedule product testing promptly to avoid delays.
- Compile Comprehensive Documentation: Begin assembling your DMF, PMF, Risk Management, and QMS files early.
- Schedule Pre-Audit Assessments: Engage notified bodies or consultants to identify gaps.
- Submit Manufacturing License Application (Form MD7): After successful testing and documentation.
- Prepare for CDSCO Audit: Ensure compliance and readiness.
Embarking on the CDSCO licensing journey for your resorbable calcium salt bone void filler device requires meticulous planning and expert guidance. Our proven track record and dedicated support will help you achieve timely approvals and seamless market entry. Contact us today to initiate your application process.
