MD-40 vs MD-49 Explained: Why NABL and CDSCO Approval Saves Your Testing Budget

Every month of delay costs a medical device manufacturer time, money, and market share. Many of these delays come from re-testing when data from non-recognized labs gets rejected during CDSCO evaluation.

If your lab is not registered under Form MD-40 and accredited by NABL (ISO/IEC 17025), your reports may not be accepted for Indian submissions. The good news is that partnering with a CDSCO-approved and NABL-accredited lab eliminates these problems, reduces redundant testing, and helps your product reach the market faster.

Understanding CDSCO Approval for Testing Laboratories

The Central Drugs Standard Control Organisation (CDSCO) regulates medical device testing in India through a three-tier system:

1. Central Government Labs – Operated by the Ministry of Health.
2. CDSCO-Recognized Private Labs – Registered under Form MD-40.
3. NABL-Accredited Labs – Certified for technical competence under ISO/IEC 17025.

Note: There is no “Form MD-49” for laboratories. The correct registration form is MD-40.

For a private testing lab to achieve CDSCO recognition, it must first be NABL-accredited. This establishes the lab’s competence and quality management systems before CDSCO grants approval.

MD-40 (Not MD-49): The Official CDSCO Lab Registration Form

The approval process is straightforward:

• Step 1: Apply with Form MD-39 and required documentation.
• Step 2: CDSCO reviews technical scope, equipment, and staff.
• Step 3: Successful labs receive a Form MD-40 Certificate of Registration.
• Step 4: Once listed, reports from the lab are automatically accepted by CDSCO.

Typical timeline: 6 to 8 weeks from application to registration.

You can find more about the CDSCO medical device approval process for manufacturers here.

CDSCO vs NABL Accreditation: What’s the Difference?

Why Dual Accreditation Matters (BIS + NABL)

For Indian manufacturers, using a dual-accredited lab that is recognized by both BIS and NABL can save weeks of processing time.

Benefits include:

• Single testing cycle: One test file supports both CDSCO and BIS submissions.
• Reduced re-testing: Reports accepted by regulators the first time.
• Traceable evidence: Reports align with ISO 13485 and IEC 60601 standards.

Read how dual accreditation improves report acceptance in our BIS and NABL guide.

Timeline and Regulatory Benefits for Manufacturers

Using a CDSCO-approved lab accelerates testing and minimizes risk:

• Predictable Schedules: Faster report delivery with defined turnaround times.
• Regulatory Confidence: Direct report acceptance by CDSCO officers.
• Cost Efficiency: No re-testing, redesign, or compliance delays.
• Audit-Ready Reports: All documentation formatted per MDR 2017 and BIS standards.
• Export Readiness: NABL’s ILAC MRA membership allows reports to support international submissions.

Partner with Astute Labs

Astute Labs is among India’s few facilities recognized by CDSCO under Form MD-40 and accredited by NABL (ISO/IEC 17025).
Our Pune-based lab offers:

• Electrical safety testing (IEC/EN 60601)
• Environmental and reliability validation
• Packaging, ageing, and mechanical safety evaluation

With our CDSCO, BIS, and NABL accreditations, your test data is regulatory-ready from day one. Contact us to align your device testing with India’s latest MD-40 framework.