CDSCO Registration for Hearing Aids

Hearing aids are classified as Class B medical devices in India and must be registered with the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017. CDSCO registration for hearing aids ensures the devices meet required safety and quality standards before they can be manufactured, imported, or sold in India. Without CDSCO approval, hearing aids cannot be legally marketed.

What is CDSCO Registration for Hearing Aids?

CDSCO Registration for Hearing Aids is the official approval granted by India’s regulatory authority, the Central Drugs Standard Control Organization (CDSCO), under the Medical Device Rules, 2017. Manufacturers or importers must obtain this approval before they can legally sell or distribute hearing aids classified as Class B (low to moderate risk) medical devices in India.

It confirms that the hearing aid meets required safety, quality, and performance standards, ensuring it is approved for use in the Indian market. Specifically:

• Hearing aids fall under the ENT medical devices category and are classified as Class B by CDSCO
• The relevant licenses are:
• Form MD-5 (manufacturing license) for domestic production
• Form MD-15 (import license) for bringing hearing aids into India

Why is CDSCO Registration for Hearing Aids required in India?

CDSCO Registration for Hearing Aids is required in India to ensure that these medical devices meet the necessary safety, quality, and performance standards before being made available to patients. Since hearing aids are used directly by individuals with hearing impairments, they are considered Class B medical devices under the Medical Device Rules, 2017.

The main reasons why CDSCO registration is necessary include:

• Patient Safety – To ensure hearing aids are safe for long-term use and free from harmful defects.
• Quality Assurance – Registration guarantees that the devices meet internationally accepted manufacturing and testing standards.
• Regulatory Compliance – Without CDSCO approval, the manufacturing, import, or sale of hearing aids in India is not legally permitted.
• Market Authorization – Only registered products can be supplied to hospitals, clinics, and retail outlets across India.
• Public Trust – Certification from CDSCO assures users and healthcare providers about the device’s authenticity and reliability.

     , functioning under the Ministry of Health and Family Welfare, Government of India.

Within CDSCO, the overall responsibility lies with the:

1. Drugs Controller General of India (DCGI):

• Head of CDSCO.
• Grants approval for import, manufacture, and registration of medical devices including hearing aids.

2. State Licensing Authorities (SLAs):

• Work in coordination with CDSCO.
• Handle licensing for manufacturing sites of Class A and Class B medical devices, which includes hearing aids.

Since hearing aids are classified as Class B medical devices under the Medical Device Rules, 2017, their registration and regulation are monitored by both CDSCO (at the central level) and State Licensing Authorities (at the state level).

What Documents are Required for CDSCO Registration for Hearing Aids?

• Covering Letter
• Application Form (Form MD-3 / MD-4 for manufacturer, Form MD-14 / MD-15 for importer)
• Device Master File (DMF)
• Plant Master File (PMF)
• Free Sale Certificate (FSC) / Certificate from National Regulatory Authority (for import)
• ISO 13485 Certificate
• CE Certificate / US FDA Approval (if available)
• Power of Attorney / Authorization Letter (for foreign manufacturer)
• Labeling Details
• Test Reports / Clinical Evidence (if applicable)
• Undertaking / Declaration of compliance with MDR 2017
• Fee Receipt

What is the Step-By-Step Process of CDSCO Registration for Hearing Aids?

1. Check Classification of Device

• Verify that hearing aids fall under the notified medical devices list and check their risk class (as per MDR, 2017).

2. Prepare Required Documents

• Collect all mandatory documents such as Device Master File (DMF), Plant Master File (PMF), ISO 13485 certificate, Free Sale Certificate (for importers), labeling details, test reports, etc.

3. Create SUGAM Portal Account

• Register on the CDSCO SUGAM online portal as a manufacturer or importer.

4. Submit Application Form

• For manufacturers – File Form MD-3.2
• For importers – File Form MD-14.

5. Pay Prescribed Fees

• Pay the government fees a per the Medical Device Rules, 2017, while submitting the application.

6. Review by CDSCO

• CDSCO examines documents, technical details, and compliance with safety and quality standards.
• Queries or deficiency letters may be raised for clarification.

7. Grant of License / Registration

• If all requirements are fulfilled, CDSCO issues:
• Form MD-5 (manufacturing license) or
• Form MD-15 (import license).

8. Post-Approval Compliance

• The license holder must follow labeling requirements, quality checks, and maintain periodic compliance as per CDSCO norms.

What is the Validity for CDSCO Registration for Hearing Aids?

The CDSCO Registration for Hearing Aids is valid for 5 years from the date of issue, unless it is suspended or cancelled earlier by the Central Licensing Authority under the provisions of the Medical Device Rules, 2017.

What are the Govt. Fees Involved in CDSCO Registration for Hearing Aids?

The government fees for CDSCO Registration of Hearing Aids are prescribed under the Medical Device Rules, 2017. The applicable fees depend on whether the applicant is an importer or a domestic manufacturer:

For Import of Hearing Aids (Form MD-14/15):

• USD 2,000 for the registration of a single manufacturing site.
• USD 1000 for each distinct medical device (hearing aid model/variant).

For Domestic Manufacturing of Hearing Aids (Form MD-3/6):

• ₹5,000 for the manufacturing site.
• ₹500 for each distinct medical device (hearing aid model/variant).

What are the Penalties for Selling without CDSCO Registration for Hearing Aids?

S.No.	Type of Violation	Penalty Under Drugs & Cosmetic Act, 1940
1.	Importing or selling hearing aids without a valid CDSCO license	Imprisonment up to 3 years and/or fine up to ₹5,000 (Section 27)
2.	Manufacturing hearing aids without CDSCO license	Imprisonment up to 3 years and/or fine up to ₹5,000 (Section 27)
3.	Repeat offence (import, sale, or manufacture without registration	Higher imprisonment up to life term and fine up to ₹5 lakh depending on the severity (Section 27(a), 27(b))
4.	Confiscation of stock	Unregistered hearing aids may be seized or destroyed by the regulatory authority

How Does ELT Corporate help with CDSCO Registration for Hearing Aids?

ELT Corporate acts as a trusted regulatory consultancy that provides complete end-to-end support for obtaining CDSCO Registration for Hearing Aids. Since hearing aids are regulated as medical devices under the Medical Device Rules, 2017, the registration process involves technical documentation, approvals, and compliance checks. ELT Corporate simplifies this journey for manufacturers, importers, and distributors.

• Regulatory Guidance – Explains the classification of hearing aids and applicable CDSCO rules.
• Document Preparation – Assists in preparing and reviewing all required documents such as Form MD-14/MD-15, Free Sale Certificate, ISO 13485, etc.
• Application Filing – Submits the online application on the CDSCO SUGAM portal correctly.
• Liaison with CDSCO – Coordinates with regulatory authorities for queries, clarifications, or deficiency letters.
• License Procurement – Ensures timely grant of Import or Manufacturing License for hearing aids.
• Renewal Assistance – Helps with license renewal before expiry to avoid penalties.
• Post-License Compliance – Provides continuous compliance support such as labeling checks, quality management, and audits.