MD 42 License: Registration, Application Process & Expert Consultants

Introduction of MD 42 License

The Indian medical device market is worth $11 billion in 2023. It has strict rules to ensure patient safety and product effectiveness.
The MD 42 License is key to these regulations. A required medical device registration certificate exists.
The authorities issue this certificate under the Medical Devices Rules, 2017. The Central Drugs Standard Control Organization (CDSCO) and State Licensing Authorities (SLAs) manage this license. It lets retailers, wholesalers, importers, and e-commerce platforms sell, stock, or distribute medical devices legally in India.

The 2022 Amendment (GSR 754(E)) now requires businesses to obtain the MD 42 License. This includes large-scale e-commerce companies like Amazon and Flipkart. Sellers must submit this certificate before they can list their devices.
This guide explains the goals of the license. It covers the application process and compliance requirements. It also discusses how the license helps access India’s growing healthcare market.

What is the MD 42 License ( Medical Device License)?

business complies with safety and quality standards for handling CDSCO-approved medical devices, including:

• Domestic or imported devices (e.g., surgical instruments, implants, IVDs).
• Devices categorized by risk (Classes A to D).
• E-commerce sales (sites such as PharmEasy).

Key Features:

• Validity: Lifetime, with a retention fee of ₹3,000 every five years.
• Scope: Mandatory for retailers, wholesalers, stockists, and importers.
• Legal Requirement: Non-compliance attracts penalties up to ₹5 lakh or license cancellation.

Objectives of the MD 42 License/Registration

1. Consumer Safety: Prevent the distribution of substandard or counterfeit devices.
2. Regulatory Oversight: Centralise tracking via the CDSCO portal (SUGAM) to monitor supply chains.
3. Quality Assurance: Enforce adherence to Good Distribution Practices (GDP), including proper storage (temperature, humidity) and sourcing from licensed manufacturers.

Who Needs an MD 42 License?

• Retailers

Entities: Pharmacies, clinics, and online platforms (e.g., 1mg, Netmeds) selling directly to consumers.

Requirement: Display the license prominently at the point of sale.

• Wholesalers

Entities: Distributors supplying hospitals, clinics, or smaller retailers.

Requirement: Maintain records of bulk transactions for two years.

• Importers

Entities: Businesses importing devices into India, including IVDs and implants.

Requirement: Submit import permits (Form MD-14/15) alongside MD-42.

• Stockists/Exhibitors

Entities: Entities storing or displaying devices for sale (e.g., trade fairs).

Requirement: Comply with storage guidelines per device class.

The CDSCO categorizes devices into four risk-based classes. Below is the list of medical devices under each class and their regulatory pathways:

Note: Class C and D devices require medical device approval via Form MD-14 (import) or MD-15 (manufacture).

Step-by-Step Application Process of MD 42 License 

1. Document Preparation

• Form MD-41: Primary application form with business details, device list, and premises address.
• Premises Proof: Rent agreement, ownership documents, or sale deed.
• Technical Staff Credentials:

1. Degree in Pharmacy/Life Sciences or
2. Registered pharmacist or
3. 1+ year of experience in medical device sales.

• Self-Certification: Declaration of GDP compliance (storage, record-keeping).

2. Online Submission via CDSCO SUGAM Portal

• Step 1: Register on the SUGAM Portal using GSTIN and business PAN.
• Step 2: Upload scanned copies of Form MD-41, premises proof, and staff credentials.
• Step 3: Pay the ₹3,000 fee online via UPI/net banking.

3. SLA Review & Inspection

• The SLA reviews documents within 30 days and may conduct site inspections to verify:
• Storage facilities (temperature logs, pest control).
• Technical staff availability.
• GDP compliance.
• Approval Timeline: 30–90 months.

4. License Issuance

• Successful applicants receive the license in Form MD-42, valid indefinitely.

Compliance Requirements

1. Display License: Visible at the business premises or e-commerce profile.
2. Storage Conditions:

Class A/B: Room temperature (15–25°C).

Class C/D: Refrigerated storage (2–8°C) with humidity control.

1. Record-Keeping: 
   Maintain sales/purchase records for two years, including:
   1. Batch numbers, expiry dates.
   2. Supplier/CDSCO-approved manufacturer details.
2. Inspection Readiness: Keep Form MD-43 for SLA officers to record observations.

Benefits of MD 42 License

• Legal Compliance: Avoid penalties like license cancellation or fines (₹1–5 lakh).
• Market Access:

Qualify for government tenders (e.g., NHA’s PMJAY scheme).

Partner with hospitals like Apollo and Fortis.

• Consumer Trust: Build credibility with B2B/B2C buyers through CDSCO-approved status.
• E-Commerce Eligibility: Sell on platforms like Amazon, Flipkart, and Practo.

Challenges in Obtaining the License

1. Document Complexity: Delays caused by absent technical staff credentials or GDP statements.
2. Regulatory Updates: Frequent amendments (e.g., 2022’s GSR 754(E)) require constant vigilance.
3. Inspection Delays: SLA backlogs may extend timelines beyond 3 months.

Key Functions of the SUGAM Portal

1. Application Tracking: Users can monitor the real-time status of their applications, receiving updates such as "Under SLA Review." ​
2. Fee Payment: The portal allows you to pay retention fees. You need these fees every five years to keep your license valid. ​
3. Post-Approval Changes: License holders can ask to change their license details. This includes updates for new devices or changes in locations.
4. Database Access: Stakeholders can access a complete list of CDSCO-approved medical devices. They can search by brand names or Importer (IMP) codes.

Validity and Renewal of MD 42 License

• Lifetime Validity: The MD 42 license does not expire. However, you must pay a fee of ₹3,000 every five years to keep it active. ​
• Late Fees: Delayed payments incur a monthly penalty of 2%. If the retention fee remains unpaid for six months, the authorities revoke the license. ​
• Reapplication: If your license revokes, you must submit a fresh application. Utilize Form MD-41 to obtain a new license.

Why Choose PSR Compliance Consultant for MD 42 License and Import License Solutions?

Trustworthy Expertise

PSR Compliance has over ten years of experience. We have a team of more than 120 CDSCO experts.

We make MD 42 license approvals simple. We handle everything from drafting Form MD-41 to coordinating SLA inspections. ​

Lightning-Fast Services:

• Pan-India Reach: Achieving an average approval timeline of 30 days.​
• Swift Processing: Licenses can be obtained within just 15 to 30 business days.

End-to-End Support:

• Documentation: Assistance in the accurate preparation of technical staff credentials, premises proof, and Good Distribution Practice (GDP) compliance documentation.​
• SUGAM Portal Management: Facilitation of hassle-free submissions and management of the ₹3,000 fee payment.​
• Post-Approval Care: Support with license renewals, audits, and modifications to ensure ongoing compliance. ​

Your MD-42 License, Our Expertise!