CDSCO License for Acupuncture electrical  stimulation system

Comprehensive Guide to CDSCO Licensing for Acupuncture Electrical Stimulation Systems (Class B)

Acupuncture electrical stimulation systems are innovative medical devices designed to apply controlled electrical stimuli to acupuncture points for pain management. Given their therapeutic significance and electrical nature, these devices fall under Class B in India’s regulatory framework, making regulatory compliance essential for manufacturers and importers targeting the Indian market.

With over 25 years of experience assisting 500+ companies in securing CDSCO licenses, we provide you with an in-depth roadmap covering everything from risk classification to licensing timelines, documentation, costs, and common challenges.

CDSCO Regulatory Framework for Acupuncture Electrical Stimulation Systems

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Your acupuncture electrical stimulation system is regulated under the Medical Device Rules (MDR) 2017, implemented to ensure safety, efficacy, and quality.

Following the notification File No. 29/Misc./03/2020-DC (178), dated 13.9.2021, this category of devices is classified as Class B (low-moderate risk). This classification directly influences the licensing pathway, audit requirements, and fees.

Risk Classification and License Requirements for Class B Devices

Class B devices like acupuncture electrical stimulation systems require a manufacturing license under Form MD3 (MD5 license) granted by the State Licensing Authority. Importers also require an import license (Form MD14 for MD15 license) from CDSCO’s central authority.

Class B devices are considered low to moderate risk, necessitating strict adherence to quality management systems and compliance with essential principles.

For detailed classification criteria, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5 License) for Class B Devices

Step-by-step process:

1. Test License Application: Begin with obtaining a Test License (Form MD13) from the State Licensing Authority. This allows you to manufacture the device for testing purposes.
2. Product Testing: Get your device tested at government-approved laboratories listed on the CDSCO Testing Laboratories portal.
3. Document Preparation: Prepare the comprehensive license application, including technical and quality files.
4. License Application: Submit Form MD3 for the MD5 license through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body from the CDSCO approved list will conduct an audit of your manufacturing facility and documentation. Check the list of notified bodies for eligible auditors.
6. Queries Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon satisfactory compliance, the MD5 license will be granted.

For a detailed overview, consult our MD5 License guide.

Manufacturing License Documents Required

Ensure you have the following documents ready when applying:

• Company Constitution: Incorporation certificate, partnership deed, or memorandum of association.
• Proof of Premises Ownership: Rent agreement or ownership documents.
• Technical Staff Details: Qualification and experience certificates of technical personnel.
• Fire and Pollution NOCs: No objection certificates from relevant authorities.
• Device Master File (DMF): Detailed product specifications, manufacturing processes, and quality controls. Our Device Master File guide elaborates this.
• Plant Master File (PMF): Details about the manufacturing facility, infrastructure, and equipment. Learn more in our Plant Master File guide.
• Essential Principles Checklist: Compliance checklist confirming conformity with MDR.
• Risk Management File: Documented risk analysis and mitigation strategies per ISO 14971 guidelines. See our Risk Management resource.
• Test Reports: Certificates from CDSCO-approved labs.
• Labels and Instructions for Use (IFU): Drafts of product labels and user manuals.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs.

Import License Process (MD15 License) for Acupuncture Electrical Stimulation Systems

If you intend to import these devices, you'll need an import license under Form MD14 (MD15 license) issued by the CDSCO Central Licensing Authority.

Key steps:

1. Document Preparation: Collate manufacturing license from the country of origin, free sale certificate, CE certificate, ISO 13485:2016, and other required documents.
2. Application Submission: Apply via the CDSCO MD Online Portal.
3. Review and Queries: Respond to queries from CDSCO.
4. License Grant: Upon clearance, the import license is issued.

For a comprehensive walkthrough, see our Import License guide.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license for distribution in India
• Company Constitution
• Manufacturing License of the device

Timeline and Processing Duration

The entire manufacturing license process for Class B devices typically takes 3-4 months, broken down as:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3-6 weeks depending on lab workload
• Audit and License Granting: 4-6 weeks

Import licenses usually require 5-6 months due to detailed document verification and cross-border compliance.

Government Fees and Costs

For the MD5 license:

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Additional costs include testing fees at government-approved labs and notified body audit charges, which vary based on scope.

Import license fees depend on device class:

• Class B: Approx. $2,000 per site +$1,000 per product

Budget accordingly to avoid surprises.

Common Challenges and Solutions

• Incomplete Documentation: Avoid delays by using detailed checklists and expert review.
• Testing Delays: Engage early with approved labs to schedule testing slots.
• Audit Non-Compliance: Conduct pre-audit mock inspections to identify gaps.
• Query Resolution Delays: Assign dedicated personnel for prompt responses.

By anticipating these issues, you can streamline the approval process significantly.

Expert Consultation and Support

Navigating CDSCO regulations for Class B acupuncture electrical stimulation systems requires precise knowledge and experience. Our team has supported over 500 manufacturers and importers, offering:

• End-to-end license application management
• Document preparation and gap analysis
• Pre-audit readiness assessments
• Regulatory updates and compliance training

Partnering with experts reduces time to market and compliance risks.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device risk class using the Medical Device Classification guide.
2. Initiate Test License Application: Prepare and submit Form MD13 through the CDSCO MD Online Portal.
3. Engage Approved Testing Laboratories: Book product testing early to fit timelines.
4. Compile Required Documentation: Utilize our Device and Plant Master File guides for thorough documentation.
5. Schedule Audit with Notified Body: Early coordination ensures audit slots.
6. Submit Manufacturing License Application: File Form MD3 online and prepare for follow-up.

Starting early and following this structured approach will position your product for successful market entry in India.

For personalized assistance, contact us to leverage our 25+ years of regulatory expertise in CDSCO licensing for medical devices like acupuncture electrical stimulation systems.