Silvereye Certifications

CDSCO Manufacturing Test License (MD-12/MD-13): Complete Registration Guide 2026

MD-12 is the application form, and MD-13 is the test license that CDSCO gives for manufacturing small batches of Class A, B, C, or D medical devices.
Applications are done online through the NSWS portal ( nsws.gov.in ), and the earlier CDSCO MD Online portal is not used anymore for fresh submissions, so don’t rely on that.
In general, the CDSCO manufacturing test license stays valid for 3 years, and you can keep it running by paying the retention fee on time.
Most cases see approval in about 2–4 months, but it can shift based on how complete the documents are, and also on how fast the queries get answered.

What Is the CDSCO Manufacturing Test License?

The CDSCO manufacturing test license lets a manufacturer produce small quantities of a medical device (Class A, B, C, or D) purely for clinical investigation, testing, evaluation, demonstration, or training — before commercial sale. The manufacturer applies online through Form MD-12 on the NSWS portal, attaches the required device and facility documents, and pays the prescribed government fee. After document verification, the Central Drugs Standard Control Organisation (CDSCO), the Central Licensing Authority, issues the approval as Form MD-13. This MD-13 test license is typically valid for 3 years and is a mandatory step before applying for a full commercial manufacturing license under the Medical Device Rules, 2017.

What Is CDSCO, and Why Is the Test License Required?

CDSCO (Central Drugs Standard Control Organisation) is India's national regulatory authority for drugs and medical devices, functioning as the Central Licensing Authority under the Medical Device Rules, 2017. Before any new medical device can be manufactured commercially, the manufacturer must first prove the device works safely under controlled conditions. The MD-12/MD-13 test license route exists for exactly this purpose — it allows limited-batch production for trials and evaluation, without requiring a full commercial license upfront

Benefits of the CDSCO MD-13 Test License

Allows legal small-batch manufacturing for clinical investigation and performance evaluation.
Generates real-world performance data needed for the full manufacturing license application.
Helps validate quality management systems and facility readiness before scaling up.
Builds regulatory credibility with CDSCO ahead of commercial license applications.
Mandatory prerequisite for Class A, B, C, and D device manufacturers seeking commercial approval.

Eligibility Criteria for MD-12 Application

Any individual or company intending to manufacture a medical device in India for non-commercial purposes — testing, clinical investigation, demonstration, evaluation, or staff training — is eligible to apply. The applicant must have:

A registered manufacturing premises with the equipment and instruments needed for the specific device.
Qualified technical personnel responsible for manufacturing and quality testing.
A valid NSWS portal account and Sugam portal registration.
A clearly defined non-commercial purpose stated in an undertaking.

Step-by-Step MD-12 to MD-13 Registration Process

Create an account on the NSWS portal (nsws.gov.in) and complete Sugam portal registration.
Classify the medical device under Class A, B, C, or D as per the Medical Device Rules, 2017.
Fill the online Form MD-12 with device details, intended use, manufacturing purpose, and facility information.
Upload all supporting documents as per the official MD-12 checklist.
Pay the applicable government fee through the portal.
Submit the application for review by the Central Licensing Authority.
Respond to any queries or deficiency letters raised by CDSCO.
On satisfactory review, CDSCO grants the test license as Form MD-13.

Documents Required for MD-12 Application

Covering letter stating the objective of the test license.
Brief description of the medical device — intended use, materials, and design.
Undertaking to confirm the availability of equipment, instruments, and personnel.
List of manufacturing and testing equipment.
List of qualified technical and quality personnel with credentials.
Device Master File and Plant/Site Master File.
Evidence of quality management system implementation.

CDSCO MD-12/MD-13 Fees and Validity

Particular	Detail	Notes
Application Form	MD-12	Filed online via the NSWS portal
License Granted As	MD-13	Issued by CDSCO (Central Licensing Authority)
Government Fee	As per Medical Device Rules, 2017	Check the current rate on the NSWS/CDSCO checklist
Validity	3 years from issuance	Maintained via retention fee payment
Processing Time	Approx. 2-4 months	Depends on document completeness

Renewal and License Retention

The MD-13 test license does not get a new expiry date on renewal. Instead, manufacturers maintain their validity by paying the prescribed retention fee through the NSWS portal before the 3-year period lapses, along with updated Device Master File, Plant Master File, and quality management system records. Failure to pay the retention fee or submit updated documents on time can lead to suspension of the license.

From Test License to Commercial Manufacturing License

Once trial data, performance evaluation results, and quality records are ready, manufacturers move to the commercial stage. Class A and B devices apply via Form MD-3 for a license granted as Form MD-5, while Class C and D devices apply via Form MD-7 for a license granted as Form MD-9. The MD-12/MD-13 test license is the foundation that makes this next step possible — CDSCO expects evidence from test manufacturing before granting full commercial authorisation.

Conclusion

Securing a CDSCO manufacturing license through the MD-12 application and MD-13 grant process is a critical regulatory milestone for any medical device manufacturer in India. Understanding device classification, document requirements, fees, and timelines helps manufacturers plan effectively and stay compliant under MDR 2017. For the most accurate and updated requirements, always refer to the official CDSCO and SUGAM portal guidelines.

Search This Blog