MD-42 License for Medical Device

Introduction

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

1. Consumer Safety: Prevent the distribution of substandard or counterfeit devices.
   Example: In 2021, SLAs revoked licenses of 12 Delhi-based wholesalers for selling unapproved glucose strips.
2. Regulatory Oversight: Centralize 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?

1. Retailers
   1. Pharmacies, clinics, and online platforms (e.g., 1mg, Netmeds) selling directly to consumers.
   2. Requirement: Display the license prominently at the point of sale.
2. Wholesalers
   1. Distributors supplying hospitals, clinics, or smaller retailers.
   2. Requirement: Maintain records of bulk transactions for two years.
3. Importers
   1. Businesses importing devices into India, including IVDs and implants.
   2. Requirement: Submit import permits (Form MD-14/15) alongside MD-42.
4. Stockists/Exhibitors
   1. Entities storing or displaying devices for sale (e.g., trade fairs).
   2. 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

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:
  • Degree in Pharmacy/Life Sciences or
  • Registered pharmacist or
  • 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: 1–3 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:
   1. Class A/B: Room temperature (15–25°C).
   2. Class C/D: Refrigerated storage (2–8°C) with humidity control.
3. Record-Keeping: 
   Maintain sales/purchase records for two years, including:
   1. Batch numbers, expiry dates.
   2. Supplier/CDSCO-approved manufacturer details.
4. Inspection Readiness: Keep Form MD-43 for SLA officers to record observations.

Benefits of MD-42 License

1. Legal Compliance: Avoid penalties like license cancellation or fines (₹1–5 lakh).
2. Market Access:
   1. Qualify for government tenders (e.g., NHA’s PMJAY scheme).
   2. Partner with hospitals like Apollo and Fortis.
3. Consumer Trust: Build credibility with B2B/B2C buyers through CDSCO-approved status.
4. 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.
   • Solution: Hire regulatory consultants for error-free submissions.
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.

CDSCO Portal (SUGAM): A Detailed Guide

The SUGAM Portal is CDSCO’s digital platform for end-to-end medical device registration. Key functions include:

• Application Tracking: Real-time status updates (e.g., “Under SLA Review”).
• Fee Payment: Submit retention fees every five years.
• Post-Approval Changes: Modify license details for new devices or premises.
• Database Access: Search the list of CDSCO-approved medical devices using brand names or IMP codes.

Validity and Renewal

• Lifetime Validity: No expiration, but a ₹3,000 retention fee every five years is mandatory.
• Late Fees: 2% monthly penalty for delayed payments; license revoked after six months.
• Reapplication: Revoked licenses require a fresh submission of Form MD-41.

Why PSR Compliance is Your #1 Choice for MD-42 Licence & Import License Solutions!

Expertise You Can Trust
With over 10 years of experience and a team of more than 120 CDSCO experts, PSR Compliance ensures smooth MD-42 License approvals. From drafting Form MD-41 to SLA inspections, we handle every detail!

Lightning-Fast Services

• Pan-India Reach: 30-day average approval timeline.
• Obtain your license within just 3 to 4 business days!

 End-to-End Support

• Documentation: Error-free prep of technical staff credentials, premises proof & GDP compliance.
• SUGAM Portal Management: Hassle-free submissions & ₹3,000 fee payment.
• Post-Approval Care: License renewals, audits & modifications.

Your MD-42 License, Our Expertise!