CDSCO License for Bar dental precision attachment

Understanding Bar Dental Precision Attachment and Its Regulatory Importance

A Bar dental precision attachment is a specialized dental device designed to connect removable partial dentures to fixed bridgework using a male/female locking mechanism. Due to its critical role in dental prosthetics, ensuring compliance with Indian medical device regulations is essential for market access and patient safety. As a Class A dental device under the CDSCO classification, it falls into the low-risk category but still requires a legally valid manufacturing license for production and marketing in India.

CDSCO Regulatory Framework for Bar Dental Precision Attachments

The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India. For Bar dental precision attachments, the regulatory framework is defined under Notification 29/Misc./03/2020-DC (140) Part-5 dated 10.10.2022, which specifically covers dental devices. This notification mandates compliance with the Medical Device Rules, 2017, and adherence to essential principles related to safety, quality, and performance.

Manufacturers must apply for the MD5 manufacturing license from the State Licensing Authority, as this device is classified as Class A—low risk. The licensing process ensures that the device meets all required standards before it can be commercially distributed.

Risk Classification and License Requirements for Bar Dental Precision Attachment

Bar dental precision attachments are classified as Class A medical devices, implying minimal risk to the patient and user. Class A devices require:

• A manufacturing license under the MD5 category
• Compliance with essential principles and standards
• Testing and certification from government-approved laboratories

For detailed classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Bar Dental Precision Attachment

The MD5 license is issued by the State Licensing Authority and involves the following steps:

1. Test License Application (Form MD13): Apply for a test license valid for 1 year, allowing initial manufacturing and testing. This process typically takes 1.5-2 months.

2. Product Testing: Get the Bar dental precision attachment tested at CDSCO-approved laboratories. Refer to the List of Testing Laboratories to select an authorized lab.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and QMS documents.

4. License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo a mandatory audit by a notified body listed in the Notified Bodies List.

6. Query Resolution: Address any queries raised by the licensing authority or notified body.

7. Grant of License (Form MD5): Upon successful review and audit, the MD5 license will be granted.

The entire process from test license application to final license grant generally takes 3-4 months.

Manufacturing License Documents Required for Bar Dental Precision Attachment

Manufacturers should prepare the following documents for the MD5 application:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Tenancy of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF) outlining design, manufacturing process, and specifications (Device Master File guide)
• Plant Master File (PMF) describing the manufacturing facility (Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with regulatory standards
• Risk Management File addressing potential device risks (Risk Management guide)
• Product Test Reports from government-approved laboratories
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably aligned with ISO 13485:2016

Attention to detail in document preparation can significantly reduce processing delays.

Import License Process (MD15) for Bar Dental Precision Attachment

For importers of Bar dental precision attachments, an MD15 license issued by the Central Licensing Authority is mandatory. The process includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and QMS documents.
• Submission of the application on Form MD14 via the CDSCO MD Online Portal.
• Resolution of any departmental queries.
• Grant of the MD15 Import License.

The MD15 license process typically takes 5-6 months.

Import License Documents Required

Key documents include:

• Valid Manufacturing License from the exporting country
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Fees vary based on device class and number of products imported.

Timeline and Processing Duration for Bar Dental Precision Attachment Licensing

Planning for these timelines upfront helps avoid costly delays in market entry.

Government Fees and Costs for Licensing

For Class A devices like the Bar dental precision attachment, the fees are:

• MD5 License: Rs 5000 per application + Rs 500 per product
• Test License (MD13): Fees included within the MD5 process
• MD15 Import License: Approximately $1000 per site +$50 per product

Budgeting accurately for these fees is critical for smooth regulatory compliance.

Common Challenges and Solutions in CDSCO Licensing

• Incomplete Documentation: Many applicants face delays due to missing or incomplete documents. We recommend thorough pre-submission audits.
• Delayed Testing: Scheduling tests at government labs early can prevent bottlenecks.
• Non-compliance in Audit: Selecting an experienced notified body and preparing for audits reduces risk.

Our real-world experience with over 500 companies shows that proactive planning and expert consultation are key to successful licensing.

Expert Consultation and Support for Bar Dental Precision Attachment Licensing

Navigating CDSCO regulations can be complex. With 25+ years of experience, we provide end-to-end support:

• Detailed gap analysis of your documents
• Coordination with notified bodies and testing labs
• Application drafting and submission
• Audit preparation and post-audit query handling

Our proven track record ensures you meet regulatory expectations efficiently.

Getting Started with Your CDSCO License Application for Bar Dental Precision Attachment

1. Assess Device Classification: Confirm the Class A status via the Medical Device Classification resource.
2. Prepare Test License Application (MD13): Initiate early to cover product testing timelines.
3. Compile Required Documents: Use our Device Master File and Plant Master File guides to ensure completeness.
4. Schedule Product Testing: Book slots at CDSCO-approved labs.
5. Apply for Manufacturing License (MD5) via the CDSCO MD Online Portal: Track application status and respond promptly to queries.
6. Prepare for Notified Body Audit: Choose from the Notified Bodies List and collaborate closely.

Embarking on this journey with strategic planning and expert assistance can significantly accelerate your product’s market entry in India. Contact us to leverage our expertise and streamline your CDSCO licensing process for Bar dental precision attachments.