MD 42 Registration for Spectacles & Contact Lens Shops

The Medical Devices Rules, 2017 grant the MD-42 license. It allows the sale, storage, display, or offering of Class A and Class B medical devices. Spectacles, reading glasses, and contact lenses fall under this category.

The State Licensing Authority gives the license in Form MD-42. They oversee the sales of medical devices.

This license is important because these optical products affect eye health. They must meet safety and quality standards. The Central Drugs Standard Control Organisation (CDSCO) oversees it. The Drugs and Cosmetics Act makes sure that only qualified and registered dealers can operate.

Who Must Obtain an MD-42 License?

According to the rules, anyone or any business that sells, stocks, or distributes medical devices must register.

You need MD-42 Registration if:

- You operate an eyewear or glasses store.
- You sell contact lenses, either prescription or cosmetic.
- You operate an e-commerce platform delivering optical medical devices.
- You are a wholesaler or distributor dealing in optical or ophthalmic medical devices.
- You run a clinic or are an optometrist who sells lenses to patients.

The license makes sure you work with qualified staff. It also ensures you meet the rules set by the State Licensing Authority.

Benefits of Obtaining MD-42 Registration

An MD-42 license provides a range of legal, operational, and competitive advantages, including:

1. Legal Compliance

Avoid heavy penalties or business closures by complying with the Drugs and Cosmetics Act and MDR 2017 regulations.

2. Legitimacy & Trust

Holding a registration certificate in Form MD-42 gives credibility and builds trust with customers, suppliers, and health institutions.

3. Access to Licensed Distributors

Many top manufacturers or bulk suppliers will only deal with licensed optical retailers. A wholesale license or MD-42 registration enables B2B trade.

4. Market Expansion

Once registered, your store can supply optical devices to hospitals, educational institutions, and government contracts.

5. Quality Standards Assurance

Being registered means your store follows the right storage rules, supervision standards, and sales practices. This helps keep products safe and ensures patient safety.

Documents Required for MD-42 Registration

Here is a detailed checklist of the documents required to apply for MD-42 registration:

Business Documents:

- PAN Card of business
- GST Registration]
- Shop and Establishment Certificate
- Aadhaar or ID of the proprietor/partner

Premises & Infrastructure:

- Ownership/rent agreement
- Utility bill (latest electricity/water bill)
- Layout of premises showing dimensions
- Photographs of inside and outside shop

Medical Device & Inventory:

- Product list (spectacles, lenses, etc.)
- Description of storage conditions used
- Details of cold storage (if required)

Competent Person Documentation:

- Degree/diploma in pharmacy or optomtry from a recognized university/institutio
- Experience certificate in sales activities of medical or otical devices
- Appointment letter of the competent person

PSR Compliance helps compile and validate these documents to eliminate delays or rejections

Step-by-Step Process of MD-42 Registration

To get your registration certificate in Form MD-42, you need to follow several steps. The Medical Device Office or Drug Inspector from the State Licensing Authority supervises these steps.

Step 1: Initial Consultation

Our experts assess your business model, setup, and readiness. Based on your type (retail, wholesale, clinic), PSR Compliance Consultant prepares a custom checklist.

Step 2: Documentation and Filing

We assist in collecting, preparing, and formatting documents to ensure compliance with MDR 2017 guidelines

Step 3: Submission of Application

We submit the application in Form MD, as required by CDSCO. We also include the government fee to the State Licensing Authority.

Step 4: Premises Inspection

The Medical Device Officer or Drug Inspector will visit the site to assess:

- Infrastructure and storage conditions
- Availability of a qualified competent person
- Proper display and stocking of devices

Step 5: Grant of MD-42 License

Upon successful inspection and document verification, the registration certificate in Form MD-42 is issued. PSR Compliance Consultant provides a digital and physical copy for your records.

Competent Person Requirement under MD-42

According to the Medical Devices Rules, 2017, every location must have a qualified person to oversee medical device sales.

Acceptable Qualifications:

- Registered Pharmacist
- Optometrist with recognized certification
- Science Graduate with 1-year experience in medical device retail

Their role is to maintain records, ensure compliance, and be present during inspections. If your store lacks one, PSR Compliance Consultant can assist you in hiring or qualifying the right candidate.

Validity and Renewal of MD-42 Registration

The validity of registration certificate issued in Form MD-42 is perpetual, meaning it doesn’t need yearly renewal. However, you must:

- Pay a retention fee every five years from the date of issue.
- Inform the State Licensing Authority of any changes (e.g., address, competent person).
- Maintain inspection-readiness and sales records.

Failure to pay the retention fee or report changes may lead to cancellation or suspension. PSR Compliance Consultant provides renewal alerts and support to ensure you remain compliant.

Why Choose PSR Compliance Consultant for MD-42 Registration?

PSR Compliance Consultant is a trusted compliance and licensing partner offering MD-42 registration services PAN India. We handle the process from handling to finishing — so you can focus on growing your optical business.

In a strict environment, selling optical medical devices such as glasses and contact lenses is risky. Also, it is not compliant without MD-42 registration. Under the Drugs and Cosmetics Act and MDR 2017, every retailer or distributor must register. This registration is under the supervision of the State Licensing Authority.

By getting your registration certificate in Form MD-42, you ensure legal compliance. This also boosts your reputation, improves product safety, and helps you access top suppliers and buyers.

Our Services Include:

- Eligibility consultation
- Document preparation and Form MD submission
- Liaison with State Licensing Authorities
- Inspection preparation and follow-up
- Post-registration support, renewals, and amendments

We help you operate legally while following the rules for sales activities. We also ensure you comply with the Ministry of Health and Family Welfare regulations.