What is a Medical Device Sale License?
A Medical Device Sale License is a certificate given by the State Drug Control Department that lets businesses sell, stock, show, or offer for sale medical devices covered by the Medical Device Rules (MDR), 2017. This license is usually required through Form MD-42, depending on the type of device and how the sale is conducted.
Who Needs a Medical Device Sale License?
- You need this license if your business is involved in:
- Selling medical devices to the public
- Distributing medical devices in bulk
- Keeping and displaying devices for sale
- Online platforms that deal with medical devices
- Hospitals or diagnostic labs that sell or distribute medical devices
Types of Sale Licenses Under MDR:
1) Retail Medical Device License (Form MD-42)– Given to businesses that sell medical devices directly to customers.
2) Wholesale Medical Device License (Form MD-42)– Given to businesses that sell in bulk to hospitals, pharmacies, or other stores.
Note: These licenses mainly apply to Class A and B medical devices.
Class C and D devices need more strict approvals.
Documents Required for Medical Device Sale License:
Align Reg Solutions ensures an easy documentation process.
Required documents include:
- Application Form MD-42
- Company details: name, registration, address
- Proof of business location (ownership or lease)
- Qualification certificate of a competent person (minimum diploma or degree in Pharmacy or related field)
- List of medical devices you plan to sell
- Undertaking on the classification of products
- Site plan and details of storage facility
- Affidavit or declaration as required by CDSCO guidelines
Qualification of Competent Technical Staff
To follow the Medical Device Rules, 2017, you must appoint a qualified technical staff member who meets these criteria:
- Has a degree or diploma in pharmacy, science, or medicine from a recognized university
- Has good knowledge of handling and regulations for medical devices
- Available full-time at the business location
Align Reg Solutions helps you find, hire, and onboard qualified staff as per the rules.
Timeline for Approval
The usual time for approval from the Licensing Authority is between 15 to 30 working days, depending on how complete the documents are and how quickly the department processes them.
Validity & Renewal
- The MD-42 license is valid forever, but you must pay a retention fee every 5 years.
- There is no fixed expiry, but not following the rules may result in the license being suspended or canceled.
Align Reg Solutions helps you track and renew your license on time, making sure your business stays running smoothly.
How We Support You
As a regulatory compliance expert, Align Reg Solutions India Private Limited offers complete support, including:
- Assessing medical devices and classifying them
- Helping with documentation and filing of Form MD-42
- Communicating with the State Drug Licensing Authority
- Guidance on selecting and hiring qualified technical staff
- Managing compliance and preparing for audits
- Keeping you updated after approval and helping with license renewal
Why Choose Us?
Experienced Regulatory Consultants – Many years of hands-on experience in the industry
Quick Turnaround – We help you get your documents done and submitted faster
PAN India Services – Support for businesses in all Indian states
Transparent Processes – You get full visibility from application to approval
Affordable Pricing – Cost-effective licensing services for both startups and big companies