MD-42 License for Reading Glasses - 2026 Guide

If you sell, store, or distribute reading glasses in India, you may be surprised to know that they are treated as medical devices under Indian law.

Because of this, businesses dealing in reading glasses must follow CDSCO medical device rules, and in most cases, an MD-42 License is required.

This blog explains everything in simple words, without legal confusion.

Why Are Reading Glasses Considered Medical Devices?

Reading glasses are used to correct vision. Any product that helps diagnose, prevent, or correct a medical condition falls under the Medical Devices Rules, 2017.

That is why:

• Reading glasses are notified medical devices
• CDSCO regulates their sale and distribution
• A proper license is required to avoid penalties

What Is an MD-42 License?

An MD-42 License is a registration certificate issued by the State Licensing Authority under CDSCO.

In simple terms:
👉 MD-42 allows you to legally stock, sell, or distribute medical devices in India.

For reading glasses, this applies to:

➜ Retail sellers

➜ Wholesalers

➜ Distributors

➜ Warehouses

Who Needs an MD-42 License for Reading Glasses?

You need an MD-42 license if you are:

● Running an optical store selling reading glasses

● Distributing reading glasses to retailers

● Importing and selling reading glasses through Indian entities

● Stocking reading glasses in warehouses for sale

❗ Even online sellers may need MD-42 if they store or dispatch products.

Advantages of Having an MD-42 License for Reading Glasses

Having an MD-42 license is not just about following the law. It also helps your business grow safely and confidently.

Key advantages include:

● Legal Safety
You can sell reading glasses without fear of inspections, fines, or stock seizure.

● Business Trust
Customers, suppliers, and brands trust licensed sellers more than unregistered ones.

● Smooth Inspections
Drug inspectors and authorities usually clear licensed premises without issues.

● Easy Expansion
You can open new branches or add distributors with proper licensing in place.

● Online & Offline Selling Allowed
Licensed businesses can sell through shops, warehouses, and online platforms.

● Long-Term Compliance
Since MD-42 is valid indefinitely (with 5-year retention), it gives long-term peace of mind.

● Avoids Legal Trouble
Prevents penalties, business disruption, and legal notices from authorities.

Difference Between MD-41 and MD-42

• MD-41 → Application form
• MD-42 → License issued after approval

You apply in MD-41, and after verification, the authority grants MD-42.

Basic Requirements for MD-42 License

⁃ To apply for an MD-42 license, you generally need:

⁃ Registered business (Proprietorship, LLP, Pvt Ltd, etc.)

⁃ Commercial premises or approved shop location

⁃ Proper storage conditions

⁃ Qualified or trained staff

⁃ Compliance with Good Distribution Practices (GDP)

Documents Required for MD-42 License (Reading Glasses)

Common documents include:

→ Business registration proof

→ PAN and Aadhaar of applicant

→ Premises ownership or rent agreement

→ Site plan of shop or warehouse

→ Self-declaration of GDP compliance

→ Authorization letter (if distributor)

→ Device details of reading glasses

Application Process for MD-42 License

Step 1: Online Application

Apply through the ONDLS / CDSCO online portal by filling Form MD-41.

Step 2: Document Upload

Upload all required documents carefully.

Step 3: Verification & Inspection

The Drug Control Department may inspect your premises.

Step 4: License Grant

After approval, MD-42 license is issued online.

Validity of MD-42 License

• MD-42 license is valid indefinitely
• A retention fee must be paid every 5 years
• Failure to pay can lead to suspension

What Happens If You Sell Reading Glasses Without MD-42?

Selling without a license can result in:

▪ Seizure of stock

▪ Heavy fines

▪ Legal action

▪ Closure of business

That’s why compliance is important even for small optical stores.

Why Businesses Take Professional Help

Many applicants face delays due to:

‣ Wrong form selection

‣ Incomplete documents

‣ Premises issues

‣ Misunderstanding CDSCO rules

Professional guidance avoids repeated objections and saves time.

Need Help Getting an MD-42 License for Reading Glasses?

If you want to sell or distribute reading glasses without legal risk, proper licensing is essential.

PSR Compliance helps you:

🗹 Understand MD-42 rules clearly

🗹 Prepare documents correctly

🗹 Apply and track the license online

🗹 Avoid penalties and delays

📞 Call PSR Compliance at 7065883416
One correct license today keeps your business safe tomorrow.

Frequently Asked Questions(FAQs)

❓ Who needs an MD-42 License for reading glasses?

Retailers, wholesalers, e-commerce sellers, and clinics or optometrists selling reading glasses or lenses need an MD-42 License.

❓ Why is an MD-42 License required for reading glasses?

Reading glasses are classified as medical devices under the Medical Device Rules, 2017, making the license mandatory for legal sale and distribution.

❓ What does the MD-42 License authorize?

It allows businesses to legally stock, display, sell, and distribute reading glasses and other medical devices.

❓ How do I apply for an MD-42 License?

Apply by submitting Form MD-41 on the CDSCO Sugam Portal along with fees and required documents.

❓ Is the MD-42 License different from the old drug license?

Yes, MD-42 is a specific medical device license that has replaced older drug licenses for such products.

❓ Do online sellers or multiple stores need separate MD-42 Licenses?

Yes, each physical location, warehouse, or online selling entity requires its own MD-42 License.