Central Medical Device Testing Laboratory

Forms used for submitting devices to the Central Medical Device Testing Laboratory for evaluation and certification. The reference pathway when private-lab test reports are challenged or when a device falls under CDSCO's mandatory central-testing list. Reports issued here carry primary regulatory weight in approval, dispute, and enforcement matters. Lead times depend on the test discipline, sample availability, and queue at the central facility.

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Forms covered

3 CDSCO forms in this category

MD-30

Memorandum to the Central Medical Device Testing Laboratory

Memorandum for submission to the Central Medical Device Testing Laboratory.

MD-31

Certificate of Test or Evaluation by the Central Medical Device Testing Laboratory

Certificate issued for the test or evaluation of medical devices by the central testing laboratory.

MD-32

Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer

Report generated by the Medical Device Testing Officer following device evaluation or testing.

Code	Form name	Description
MD-30	Memorandum to the Central Medical Device Testing Laboratory Memorandum for submission to the Central Medical Device Testing Laboratory.	Memorandum for submission to the Central Medical Device Testing Laboratory.
MD-31	Certificate of Test or Evaluation by the Central Medical Device Testing Laboratory Certificate issued for the test or evaluation of medical devices by the central testing laboratory.	Certificate issued for the test or evaluation of medical devices by the central testing laboratory.
MD-32	Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer Report generated by the Medical Device Testing Officer following device evaluation or testing.	Report generated by the Medical Device Testing Officer following device evaluation or testing.

Code

Form name

MD-30

Memorandum to the Central Medical Device Testing Laboratory

Memorandum for submission to the Central Medical Device Testing Laboratory.

MD-31

Certificate of Test or Evaluation by the Central Medical Device Testing Laboratory

Certificate issued for the test or evaluation of medical devices by the central testing laboratory.

MD-32

Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer

Report generated by the Medical Device Testing Officer following device evaluation or testing.

Eligibility

When you need these licences

Use this list to confirm whether this category applies to your device, role, or use case.

CDSCO referrals

Devices referred by CDSCO for evaluation as part of licensing or compliance review.

Disputed batches

Batches under regulatory dispute that require independent testing.

Reference testing

Manufacturers voluntarily seeking reference-quality testing.

What's required

Documentation checklist

Device samples per testing requirement
Device technical specifications
Reference standards and methods
Memorandum (MD-30) with submission details
Sample chain-of-custody documentation

Process

Step by step

01
Submission memorandum (MD-30)
Formal memorandum accompanying device samples to the central lab.
02
Sample receipt and registration
Lab logs samples, assigns testing protocol.
03
Testing and evaluation
Medical Device Testing Officer conducts evaluation per standards.
04
Report generation (MD-32)
Detailed test report prepared by the testing officer.
05
Certificate issuance (MD-31)
Certificate of test or evaluation issued based on results.
06
Communication of results
Findings shared with referring CDSCO office or submitting manufacturer.

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Performance Evaluation (IVD)

End-to-end engagement covering forms in this category — from documentation to license in hand.

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FAQ

Common questions

No — the Central Medical Device Testing Laboratory is CDSCO's own reference testing facility. NABL labs are independent labs registered under MD-39/40.

Mostly central lab testing happens through CDSCO referrals during licensing or compliance reviews. Voluntary submission is possible in specific cases.

Varies widely with test complexity. Simple tests: 4–6 weeks. Complex performance testing: 12+ weeks.

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