Handling CDSCO queries and deficiencies is a crucial part of the medical device registration and approval process in India. If your application has missing documents, unclear information, or needs corrections, the CDSCO will send official queries or deficiency letters. These are not rejections but opportunities to fix errors and move your application forward. If you are dealing with CDSCO compliance for the first time or facing a query and don’t know how to respond, this blog will help you to understand the process easily.
What are CDSCO Queries And Deficiency Letters?
CDSCO queries and deficiency letters are official communications sent by the Central Drugs Standard Control Organisation (CDSCO) when they find that your application for a drug or medical device registration, import license, or manufacturing approval is incomplete, unclear, or missing required information. These are not rejections but rather requests for clarification, correction, or additional documents needed before your application can move forward.
Why Does CDSCO Raise Queries During Application Review?
The CDSCO raises queries during application review to ensure that all regulatory requirements are fully met before approving a drug or medical device for sale, manufacture, or import in India. These CDSCO queries are an essential part of the evaluation process and are raised when there are gaps, mistakes, or missing information in the documents submitted. Check the pointer to know the most common reasons:
- Incomplete Documentation
- Expired or Invalid Certificates
- Incorrect or Unclear Labeling Information
- Unclear Product Classification
- Discrepancies in Technical Data
- Unverified Importer or Manufacturer Details
- Missing Justifications
At What Stage Are CDSCO Queries Usually Raised?
CDSCO queries are usually raised after the initial review of your application but before the final approval is granted. Once the CDSCO begins the scrutiny of your documents, whether for medical device registration, import license, or clinical trial approval, any gap or inconsistency in your submission triggers a query or deficiency letter.
Document Verification Stage
- Technical Review Stage
- Labeling and Packaging Review
- Importer or Manufacturer Verification
- Post Inspection or Audit Stage
What Types Of CDSCO Queries Are Common In Medical Device Registration?
Check the table to know the types of CDSCO queries that are common in medical device registration:
| S.No. | Types of Query | What CDSCO Ask | Why It Happens |
|---|---|---|---|
| 1. | Missing or Incomplete Documents | Application form, power of attorney (POA), or TR6 Challan not attached or signed | The applicant missed uploading or submitted incomplete forms |
| 2. | Invalid Free Sale Certificate (FSC) | FSC has expired or not from a competent authority | CDSCO needs a valid FSC from the country of origin to allow import |
| 3. | Improper Device Classification | Wrong classification | Applicant may not be clear on CDSCO risk classification system |
| 4. | Inadequate Product Description | Product use, feature, or specifications are vague or insufficient | CDSCO needs to understand how the device works and its clinical use |
| 5. | Lack of Clinical Evidence | Clinical trial waiver or safety/performance data is missing | Needed to prove that the device is safe and effective for Indian users |
| 6. | Incorrect Labeling Format | Labels missing importer address, MRP, or manufacturing details | CDSCO ensures compliance with labeling norms under the Medical Device Rules |
| 7. | Confusion in Manufacturer Details | Mismatch in the manufacturer’s name/address in various documents | CDSCO must confirm the authenticity and traceability of the manufacturer |
| 8. | Unverified ISO/GMP Certificate | ISO 13485 or GMP certificate not notarised/apostilled | Needed to confirm quality assurance at the manufacturing site |
| 9. | Device Master File (DMF) Issues | DMF has a missing section, like raw materials or sterilization methods | CDSCO needs full technical details for safety assessment |
| 10. | Environmental Clearance or BIS Exemption | If applicable, missing BIS or pollution control documents | Needed for devices or electronics under the BIS scope |
How Long Do I Have To Respond To CDSCO Queries?
When CDSCO raises a query or issues a deficiency letter during your medical device registration, it typically takes 90 days from the date of the query.
What Happens If I Don’t Respond To CDSCO Queries On Time?
Basically, if you don’t respond to CDSCO queries on time, then your application for medical device registration or license may get delayed, rejected, or even closed permanently.
- Delay in Approval Process
- Application May Be Rejected
- Financial Loss
- Negative Record
How To Prepare A Reply For CDSCO Deficiency Letters?
When CDSCO sends a deficiency letter, it means your application is incomplete or has issues that need clarification or correction. Responding to this letter properly and on time is very important to avoid rejection or delays. Follow these steps to prepare for a CDSCO deficiency letters:
Read the Deficiency Letter Carefully
- Check the letter line by line
- Now, understand what CDSCO is asking – missing documents, unclear data, wrong formats, etc.
- Note the deadline to respond (usually 7 to 30 days)
Make a List Of All Deficiencies
- Create a checklist of all the queries/points raised
- This helps ensure that you don’t miss anything in your reply
Collect Correct Documents or Clarifications
- You can check out the document list from the next answer
Draft a Cover Letter
- Reference to your application (File ID or Application Number)
- A list of all deficiencies and your point-wise response
- A short explanation for any delay
- Signature, date, and designation of the authorized person
Arrange All Documents Neatly
- Place the reply letter on top
- Attach documents and annexures in the same order as the deficiencies
- Number the pages and mention the annexure reference in your reply
Submit the Response to CDSCO
- If the deficiency was received through the SUGAM portal, upload your response there
- For offline cases, courier or hand-deliver the documents to the CDSCO office
- Keep a copy of the acknowledgment for further reference
What Documents Should Be Attached When Responding To CDSCO Queries?
Check the document list that is required to be attached when responding to CDSCO queries:
- Covering Letter
- Copy of CDSCO Deficiency Letter
- Application Reference Details
- Corrected/Missing Documents
- Product Label
- Device Master File (DMF)
- Plant Master File
- Test Reports
- Clinical Evaluation Report
- Notarized/Apostilled Documents
- Revised Product Brochure or Instructions for Use
- Justification Letters
- Declaration Letters
- Updated SUGAM Screenshots
- Annexures Index
Can CDSCO Raise Additional Queries After My First Response?
Yes, CDSCO can raise more queries even after you submit your first response. If your reply is incomplete or does not fully satisfy their concerns, they may issue a second deficiency letter asking for more documents, corrections, or clarifications. This is a normal part of the process and is done to make sure your medical devices meet all safety, quality, and regulatory requirements before approvals.
Is There A Format For Replying To CDSCO Queries?
Yes, there is a proper format for replying to CDSCO queries and deficiency letters, and following this format helps ensure your response is professional, complete, and easy for the CDSCO reviewers to understand. While CDSCO does not mandate a fixed template, a structured reply is expected:
- Cover Letter
- List of Attachment – FSC_USA_Notarised.pdf, QMS_ISO13485.pdf, Label_Artwork_Corrected.pdf
- Sign and Stamp
Why Choose ELT Corporate To Handle CDSCO Queries And Deficiency Letters?
Handling CDSCO queries and deficiency letters requires precision, regulatory knowledge, and timely action, and that’s exactly what ELT Corporate brings to the table, as a trusted regulatory consultancy with years of experience in medical device compliance.
- Expertise in CDSCO Compliance
- End-to-End Support
- Timely & Accurate Submission
- Proven Track Records
- Pan India Services
You can simply call us for all the details by dialing 9899997002, and also email us at info@medicaldeviceregistration.com.
What Should I Do If I Receive A CDSCO Deficiency Letter?
Carefully check all points, prepare corrected documents, draft a cover letter, and respond within the deadline.
Can I Still Get Approval If CDSCO Raises Multiple Queries?
Yes, you can get the approval if CDSCO raises multiple queries as long as you respond carefully.
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