Audit Records & Enforcement Forms

Forms used for ongoing audit-book maintenance and regulatory enforcement actions under the Medical Devices Rules and Drugs and Cosmetics Act. Cover routine inspection logbooks, observation responses, show-cause notices, and licence suspension or cancellation procedures. Maintained perpetually post-licence — gaps in these records are the single biggest cause of renewal failures and re-inspection escalations. Treat them as a living compliance trail, not a one-time filing.

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Forms covered

7 CDSCO forms in this category

MD-11

Form for Maintenance of Audit or Inspection Book

Form for maintaining the audit or inspection book as required by medical device regulations.

MD-33

Application from Purchaser for Test or Evaluation of Medical Device under Section 26 of the Drugs and Cosmetics Act

Application from the purchaser for test or evaluation of a medical device under the relevant section of the Drugs and Cosmetics Act.

MD-34

Order Requiring a Person Not to Dispose of Stock in Possession

Order issued to prevent the disposal of stock of medical devices under the Drugs and Cosmetics Act.

MD-35

Receipt for Stock of Medical Devices Seized Under Section 22 of the Drugs and Cosmetics Act

Receipt issued for medical devices seized under the provisions of the Drugs and Cosmetics Act.

MD-36

Intimation of Person from Whom Sample is Taken

Intimation to the person from whom the sample of medical devices was taken for testing.

MD-37

Receipt for Sample of Medical Device Taken Where Fair Price Tendered is Refused

Receipt for a sample of a medical device taken when the fair price is refused.

MD-38

Memorandum to Medical Device Testing Officer

Memorandum for submission to the Medical Device Testing Officer.

Code	Form name	Description
MD-11	Form for Maintenance of Audit or Inspection Book Form for maintaining the audit or inspection book as required by medical device regulations.	Form for maintaining the audit or inspection book as required by medical device regulations.
MD-33	Application from Purchaser for Test or Evaluation of Medical Device under Section 26 of the Drugs and Cosmetics Act Application from the purchaser for test or evaluation of a medical device under the relevant section of the Drugs and Cosmetics Act.	Application from the purchaser for test or evaluation of a medical device under the relevant section of the Drugs and Cosmetics Act.
MD-34	Order Requiring a Person Not to Dispose of Stock in Possession Order issued to prevent the disposal of stock of medical devices under the Drugs and Cosmetics Act.	Order issued to prevent the disposal of stock of medical devices under the Drugs and Cosmetics Act.
MD-35	Receipt for Stock of Medical Devices Seized Under Section 22 of the Drugs and Cosmetics Act Receipt issued for medical devices seized under the provisions of the Drugs and Cosmetics Act.	Receipt issued for medical devices seized under the provisions of the Drugs and Cosmetics Act.
MD-36	Intimation of Person from Whom Sample is Taken Intimation to the person from whom the sample of medical devices was taken for testing.	Intimation to the person from whom the sample of medical devices was taken for testing.
MD-37	Receipt for Sample of Medical Device Taken Where Fair Price Tendered is Refused Receipt for a sample of a medical device taken when the fair price is refused.	Receipt for a sample of a medical device taken when the fair price is refused.
MD-38	Memorandum to Medical Device Testing Officer Memorandum for submission to the Medical Device Testing Officer.	Memorandum for submission to the Medical Device Testing Officer.

Eligibility

When you need these licences

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

Licence holders

All licensed manufacturers, importers, and distributors maintain audit/inspection records (MD-11).

Enforcement context

MD-33 through MD-38 are used in enforcement situations — sampling, seizing, and testing.

Purchaser-initiated testing

Purchasers can request independent testing under Section 26 (MD-33).

What's required

Documentation checklist

Maintained audit/inspection book at facility (MD-11)
Properly documented sample collection procedures
Chain-of-custody for seized goods
Compliance with timelines for disposal restrictions

Process

Step by step

01
Routine record-keeping (MD-11)
Maintain inspection book at premises; entries updated after every audit.
02
Sample collection (MD-36/37)
Inspectors document samples with proper receipts and intimations.
03
Seizure protocol (MD-34/35)
Stock disposal restrictions and seizure receipts properly filed.
04
Testing referrals (MD-33/38)
Samples referred to testing officer with proper memorandum.
05
Compliance response
Licence holders respond to inspector findings and rectify gaps.

How Bio-State helps

Certifications & Quality

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

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FAQ

Common questions

Every CDSCO-licensed facility maintains an audit/inspection book — it's a continuous record requirement, not a one-time submission.

Inspectors take samples (MD-36 intimation, MD-37 receipt if fair price refused), then refer for testing (MD-38 memorandum). Results inform compliance status.

No — MD-34 explicitly prohibits disposal until the restriction is lifted. Violations can lead to licence suspension.

Maintain MD-11 records continuously, keep CAPA closed, internal audit reports current. We offer mock-audit services to identify gaps.

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