MD-42 License for Blood Pressure Monitors: Import Approval Step by Step Guide (2026)

If you plan to import blood pressure monitors into India in 2026, compliance is no longer something you can “figure out later.” Without the MD-42 license, your shipment can be stopped at customs, delayed for months, or rejected outright. Many importers only begin searching for terms like CDSCO, MD-42 license, or import approval after their goods are already held at the port.

By then, the cost is not just financial-it is lost trust, missed sales, and regulatory risk. The MD-42 license is the legal gateway for importing medical devices into India. This guide explains exactly how to get it, step by step.

What Is MD-42 for Blood Pressure Monitors?

MD-42 is the official Import License issued by CDSCO (Central Drugs Standard Control Organisation) for medical devices under India’s Medical Device Rules. Blood pressure monitors—whether digital, automatic, or hospital-grade-are classified as regulated medical devices. This means you cannot legally import, distribute, or sell them in India without approval from CDSCO.

In simple terms:

• MD-42 = Legal permission to import medical devices into India
• Without it, customs authorities can detain, reject, or seize shipments
• Online marketplaces, hospitals, and distributors increasingly ask for MD-42 before onboarding products

CDSCO Full Form & Its Role in Import Approval

CDSCO Full Form: Central Drugs Standard Control Organisation

CDSCO operates under the Ministry of Health & Family Welfare and regulates:

• Medical devices
• Pharmaceuticals
• Diagnostic equipment
• Import and manufacturing approvals

For blood pressure monitors, CDSCO ensures:

• Device safety and performance
• Compliance with Indian Medical Device Rules
• Traceability of importers and manufacturers

What Is MD-42 License?

The MD-42 license is an Import License issued to:

• Indian importers
• Authorized Indian agents of foreign manufacturers

It authorizes the importer to bring approved medical devices into India from overseas manufacturers.

In short:
👉 If you import BP monitors from China, Germany, Japan, or any other country—MD-42 is mandatory.

Who Needs MD-42 for Blood Pressure Monitors?

You must apply for MD-42 if you are:

➤ An importer of digital or manual BP monitors

➤ A medical device distributor

➤ An e-commerce seller listing BP monitors

➤ A hospital chain importing devices directly

➤ A brand owner sourcing from overseas manufacturers

Even if you are not manufacturing the product, selling imported medical devices without MD-42 is illegal.

Types of Blood Pressure Monitors Covered

MD-42 is required for:

● Digital BP monitors

● Automatic & semi-automatic BP devices

● Upper arm BP monitors

● Wrist BP monitors

● Clinical-grade BP measurement equipment

Both consumer-grade and hospital-use devices fall under CDSCO regulation.

Documents Required for MD-42 License

This section is critical. Missing or incorrect documents are the number one reason for rejection or delays.

From the Indian Importer

→ Importer’s License (Wholesale / Drug License, if applicable)

→ Company incorporation documents (COI, GST, PAN)

→ Authorized Signatory ID & Address proof

→ Undertaking and declaration formats

→ CDSCO portal account details (CDSCO login)

From the Foreign Manufacturer

→ Free Sale Certificate (FSC)

→ Device Master File (DMF)

→ Plant Master File (PMF)

→ ISO 13485 certificate

→ Manufacturing license

→ Product labeling & IFU (Instructions for Use)

→ Power of Attorney in favor of Indian importer

Step-by-Step MD-42 Application Process

Step 1: Product Classification

Confirm that the blood pressure monitor is classified as a medical device under CDSCO and identify its risk class.

Step 2: Document Compilation

• Collect and review:
• Manufacturer documents
• Device technical files
• Importer authorizations
  This is where most applications fail due to incomplete or mismatched data.

Step 3: CDSCO Login & Online Submission

• Log in to the CDSCO portal
• Select MD-42 (Import License)
• Upload all documents in prescribed formats

Step 4: Government Review

CDSCO verifies:

• Manufacturer credentials
• Device safety standards
• Regulatory compliance

They may raise queries or seek clarifications.

Step 5: License Approval

Once approved, CDSCO issues the MD-42 Import License, allowing legal import and distribution.

MD-42 License Cost, Timeline & Validity

MD-42 License Cost

The official government fee depends on:

Number of devices

Manufacturing sites involved

Regulatory classification

Additionally, professional handling is recommended due to the technical nature of submissions.

Timeline

Standard processing: 30–60 working days

With queries or document gaps: may extend further

Validity

MD-42 is typically valid for 5 years

Subject to compliance, audits, and regulatory updates

Real-Life Case Study

Client Name: Manoj Kumar
City: Noida, Uttar Pradesh
Business: Medical equipment importer supplying hospitals and online pharmacies

Manoj planned to import digital blood pressure monitors from a manufacturer in Shenzhen. His first shipment was stuck at customs because he did not hold an MD-42 license. Customs demanded CDSCO import approval before clearance. Facing storage charges and potential rejection, Manoj approached PSR Compliance.

Our team:

• Audited the product classification
• Collected missing manufacturer certificates
• Prepared Device Master File and regulatory declarations
• Filed the MD-42 application via CDSCO login

Within five weeks, Amit received his MD-42 license. His consignment was cleared, and he now legally supplies BP monitors across Delhi NCR without compliance risk.

Common Mistakes That Lead to Rejection

– Submitting incomplete Device Master Files

– Incorrect manufacturer authorization

– Mismatch in labeling & technical documents

– Applying under the wrong device category

– Ignoring CDSCO queries or delays in response

Why MD-42 Compliance Matters for Your Business

▪ Customs clearance without obstruction

▪ Legal protection against penalties

▪ Eligibility for hospital tenders & marketplaces

▪ Brand credibility with regulators and buyers

▪ Long-term business continuity

Without MD-42, imported BP monitors can be:
❌ Blocked at ports
❌ Removed from online platforms
❌ Penalized by regulators

How PSR Compliance Helps You

PSR Compliance provides end-to-end MD-42 licensing support, including:

✔ Device classification & eligibility check

✔ Manufacturer coordination for global documentation

✔ Preparation of DMF, PMF, and regulatory files

✔ CDSCO login, application filing, and follow-ups

✔ Query handling until final approval

FAQs – MD-42 for Blood Pressure Monitors

What is MD-42 license?
It is the CDSCO-issued import license for medical devices in India.

Is MD-42 mandatory for BP monitors?
Yes, blood pressure monitors are regulated medical devices.

Who issues MD-42?
CDSCO (Central Drugs Standard Control Organisation).

Can I import without MD-42?
No. Shipments may be detained or rejected.

How long does MD-42 approval take?
Usually 30–60 working days.

What is the validity of MD-42 license?
Typically valid for five years.

Can e-commerce sellers import BP monitors?
Yes, but only with a valid MD-42 license.

Is MD-42 required for each product model?
Yes, each device must be registered.

What is CDSCO login used for?
To apply, track, and manage medical device licenses online.

Can PSR Compliance handle the complete process?
Yes, from documentation to final approval.