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Wed, Jan 21 2026
Raju Karn
If you are planning to sell, stock, or distribute hearing aids in India, you must obtain an MD-42 license. Without this license, dealing in hearing aids is not legally allowed.
Many people think hearing aids are simple electronic products, but under Indian law, they are treated as medical devices. That is why they come under the control of CDSCO. This blog explains the MD-42 license for hearing aids in very simple words, so anyone can understand the process clearly.
An MD-42 license is a legal approval issued by the State Drug Control Authority under the Medical Devices Rules, 2017.
This license allows a business to:
In simple terms, if you are a dealer, distributor, or wholesaler of hearing aids, you need an MD-42 license.
Hearing aids directly affect a person’s health and quality of life. If low-quality or unapproved products are sold, they can cause serious harm.
The government ensures safety by:
▪ Controlling who can sell medical devices
▪ Checking storage and handling conditions
▪ Ensuring only approved devices reach users
That is why CDSCO has made MD-42 licensing mandatory.
You need an MD-42 license if you are:
➜ A hearing aid distributor
➜ A wholesaler of hearing aids
➜ A dealer supplying hearing aids to clinics or hospitals
➜ A business stocking hearing aids for sale
Retailers who only sell to end users may have different requirements, but distributors must have MD-42.
➤ Makes your hearing aid business 100% legal
➤ Builds trust with hospitals and clinics
➤ Prevents penalties and seizures
➤ Ensures smooth business operations
➤ Helps in long-term growth
To apply for an MD-42 license, you generally need:
→ Filled Form MD-41
→ Business registration documents (GST, PAN, incorporation)
→ Address proof of premises
→ Layout plan of storage area
→ Authorization letter from manufacturer (if distributor)
→ Details of responsible technical person
→ Affidavit of compliance
→ List of hearing aid models being sold
Proper documentation reduces delays and rejections.
Your business must be legally registered and the premises should meet storage requirements.
Apply through the CDSCO online / ONDLS portal using Form MD-41.
Upload all required documents carefully.
The drug authority may inspect your premises to verify storage and records.
Once approved, the MD-42 license is issued and remains valid as per rules.
Avoiding these mistakes saves time and stress.
If you are planning to sell or distribute hearing aids in India, getting an MD-42 license is a must. The process can feel confusing if you are doing it for the first time.
PSR Compliance helps businesses understand the MD-42 licensing process in simple words. From CDSCO online filing to document preparation and authority coordination, we guide you at every step so you can focus on your business without stress.
📞 Call PSR Compliance: 7065883416
Yes, from 30 September 2022, all retailers, wholesalers, and distributors selling notified medical devices, including electronic hearing aids, must obtain an MD-42 license.
MD-41 is the application submitted to the State Licensing Authority, while MD-42 is the registration certificate issued after approval.
Yes, any entity involved in selling, stocking, or distributing hearing aids must hold a valid MD-42 license.
Yes, the MD-42 license is premise-specific, and each retail outlet or warehouse requires a separate registration.
Applicants must employ qualified technical staff with a degree in pharmacy or science, or a diploma with at least one year of experience in medical device sales.
The MD-42 license is valid indefinitely, subject to payment of a retention fee every five years.
Operating without an MD-42 license can result in stock seizure, fines ranging from ₹5–10 lakhs, and possible imprisonment.
Required documents include premises ownership or rent proof, PAN/Aadhaar of the applicant, site plan, and self-certification of compliance with Good Distribution Practices (GDP).