Medical Device Testing Laboratory Registration

CDSCO registration for laboratories conducting tests or evaluations on behalf of medical device manufacturers. Required for any lab issuing test reports used in CDSCO licensing dossiers. Demands NABL accreditation in the relevant test scopes, calibrated instrumentation, trained analytical staff, and an audit history acceptable to the Central Licensing Authority. Maintained through periodic surveillance audits and scope renewals.

Get a Quote See 2 forms

Forms covered

2 CDSCO forms in this category

MD-39

Application for Grant of Registration to Medical Device Testing Laboratory for Test or Evaluation on Behalf of Manufacturer

Application for registering a medical device testing laboratory to conduct tests or evaluations for a manufacturer.

MD-40

Certificate of Registration to Medical Device Testing Laboratory for Test or Evaluation

Certificate of registration issued to a medical device testing laboratory for carrying out tests or evaluations.

Code	Form name	Description
MD-39	Application for Grant of Registration to Medical Device Testing Laboratory for Test or Evaluation on Behalf of Manufacturer Application for registering a medical device testing laboratory to conduct tests or evaluations for a manufacturer.	Application for registering a medical device testing laboratory to conduct tests or evaluations for a manufacturer.
MD-40	Certificate of Registration to Medical Device Testing Laboratory for Test or Evaluation Certificate of registration issued to a medical device testing laboratory for carrying out tests or evaluations.	Certificate of registration issued to a medical device testing laboratory for carrying out tests or evaluations.

Code

Form name

MD-39

Application for Grant of Registration to Medical Device Testing Laboratory for Test or Evaluation on Behalf of Manufacturer

Application for registering a medical device testing laboratory to conduct tests or evaluations for a manufacturer.

MD-40

Certificate of Registration to Medical Device Testing Laboratory for Test or Evaluation

Certificate of registration issued to a medical device testing laboratory for carrying out tests or evaluations.

Eligibility

When you need these licences

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

Independent test laboratories

Labs offering testing services to medical device manufacturers.

NABL accreditation preferred

NABL or equivalent ISO/IEC 17025 accreditation strengthens application.

Defined scope

Specific test methods and device categories the lab can handle.

What's required

Documentation checklist

Laboratory infrastructure documentation
Test method scope and capabilities
NABL or equivalent accreditation certificate
Technical staff qualifications
Quality management procedures
Calibration and equipment records
Independence declaration

Process

Step by step

01
Scope definition
Identify test methods and device categories to be registered.
02
MD-39 application
Submission with NABL certificate and scope documentation.
03
CDSCO assessment
Capability and quality system review.
04
Site verification
On-site verification of facilities and equipment.
05
Certificate issuance (MD-40)
Lab registered for defined scope of testing activities.
06
Scope expansion
Additional test methods can be added through scope amendments.

How Bio-State helps

Certifications & Quality

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

Explore service

FAQ

Common questions

No — MD-39/MD-40 is for labs offering testing services to third-party manufacturers. In-house QC labs at manufacturers don't need separate registration.

Strongly recommended and often required for the test methods in scope. Without accreditation, CDSCO assessment is more stringent.

Typically 12–16 weeks including site verification. Faster for labs already NABL-accredited in relevant scopes.

Need help with testing laboratory registration?

We'll send a fixed-fee quote and indicative timeline within 48 hours.

Book a Consultation