CDSCO Medical Device Registration Process: 18 Top Questions Answered (2025 Update)

Q: Can one application cover multiple manufacturing sites as per medical device import CDSCO regulations?

No. A separate application, along with requisite fees and documents, is required for each actual manufacturing site which is outlined in medical device import CDSCO regulations and is necessary for obtaining a CDSCO import license for medical devices.

Q: Can an authorised agent include their brand name in Form MD‑14 for a CDSCO import license for medical device?

Yes, but only if the brand name is mentioned in the Free Sale Certificate (FSC) issued to the legal manufacturer. The FSC must show that the product is freely sold in countries like Australia, Canada, Japan, EU, UK, or the USA. If the brand name is not listed, “Not Applicable” must be mentioned in Form MD-14.

Q: Are separate fees required for each brand under the CDSCO medical device registration process?

For medical device manufacturers and importers, grasping the nuances of MDR-2017 is crucial. One key requirement emphasized in the FAQs by CDSCO is the need for separate fee submissions for each brand when applying for manufacturing or import licenses.

Q: Is a wholesale licence required for Class A devices under Indian medical device regulation?

No. Class A devices that are non-sterile and non-measuring are exempt from the sale licensing requirements under Chapter XI of the MDR, 2017.

Q: Can Electronic Instructions for Use (e‑IFU) be used under the CDSCO medical device registration process?

MDR-2017 outlines specific procedures for a 'change of constitution' within a company, necessitating a fresh license application to ensure compliance. Additionally, the acceptance of Electronic Instructions for Use (e-IFU) marks a step towards embracing digitalization, aligning with global trends and regulatory standards as outlined in the FAQs by CDSCO.

Q: What are the Post‑Marketing Surveillance (PMS) data obligations under Indian medical device regulation?

The submission of Post Marketing Surveillance (PMS) data by license holders is a critical aspect of the regulatory framework, ensuring the continuous assessment of device safety and efficacy after market entry.

Q: How are unlisted devices/components classified under MDR-2017?

When a medical device’s classification is unclear, manufacturers can request a classification from the Central Licensing Authority, providing technical documents and information on the device’s regulatory status/ classification in other countries.

Q: Can pre-MDR‑2017 validation data be used in the CDSCO medical device registration process?

If the data is found satisfactory by the Licensing Authority, it may be accepted. In such cases, a test license in Form MD-13 is not required, streamlining the approval pathway.

This user-friendly FAQ combines the latest updates from CDSCO (FAQ Doc No. CDSCO/FAQ/MD/01/2024 and Addendum 01 dated 03 April 2025) into one easy guide. Whether you’re a manufacturer, importer, or regulatory consultant, you’ll find straightforward answers to common questions. It explains how to get a CDSCO import license for medical devices, follow medical device import CDSCO regulations, and meet key requirements under the Indian medical device regulation framework. This guide removes confusion, saves time, and links you to more detailed information when needed.

Before navigating the CDSCO’s regulatory process, it’s essential to understand the importance of an MDR gap analysis. This involves identifying gaps between your current compliance status and the requirements outlined in the Indian medical device regulation, particularly under the Medical Device Rules (MDR), 2017. Whether you’re seeking a CDSCO medical device registration or applying for a CDSCO import license for medical devices, unaddressed gaps in technical documentation, quality systems, clinical data, or labeling can delay approvals and increase regulatory risk.

By proactively assessing operations against the medical device import CDSCO regulations, manufacturers and importers can align with CDSCO expectations and streamline their approval process. The FAQs below address many of the areas where gaps commonly occur such as biocompatibility, site-specific applications, post-market surveillance, and labeling – making gap analysis a critical first step toward successful compliance.

Table of Contents: CDSCO Medical Device Registration FAQs

CDSCO Medical Device Registration Process: Your Key Questions Answered

1. What is the regulatory pathway under Indian medical device regulation?

Short answer: See CDSCO’s official flowchart CDSCO Medical Device Regulatory Pathway (PDF)
Details: CDSCO provides a detailed regulatory framework covering the complete CDSCO medical device registration process, including development, testing, approval, and post-market compliance.

2. Is ISO 13485 certification mandatory under MDR-2017 for the CDSCO medical device registration process?

Short answer: Not mandatory, though it strengthens your QMS evidence.
Details: No. While ISO 13485:2016 is globally recognized, it is not a mandatory requirement under MDR-2017 to obtain a manufacturing license in India.

3. Can one application cover multiple manufacturing sites as per medical device import CDSCO regulations?

Short answer: No. Submit a separate Form MD‑15 with fees and documents for each site.
Details: A separate application, along with requisite fees and documents, is required for each actual manufacturing site, as outlined in medical device import CDSCO regulations.

4. Can an authorised agent include their brand name in Form MD‑14 for a CDSCO import license for medical device?

Short answer: Yes, if the brand name appears on the Free Sale Certificate of an approved reference market; otherwise state “Not Applicable.”
Details: The brand name must be listed in the Free Sale Certificate (FSC) issued to the legal manufacturer. If not, “Not Applicable” should be entered in Form MD-14.

5. Are separate fees required for each brand under the CDSCO medical device registration process?

Short answer: CDSCO requires individual fee submissions per brand for manufacturing/import licences.
Details: Under MDR-2017, a separate fee must be submitted for each brand for both manufacturing and import licenses.

6. Is a wholesale licence required for Class A devices under Indian medical device regulation?

Short answer: Correct—no Form 20B/21B or MD‑42 required.
Details: Class A devices that are non-sterile and non-measuring are exempt from sale licensing requirements under Chapter XI of MDR-2017.

7. Can Electronic Instructions for Use (e‑IFU) be used under the CDSCO medical device registration process?

Short answer: Permitted if the e‑IFU is identical in content to the paper IFU and accessible at point of use.
Details: e-IFUs are allowed if identical to the printed version and accessible by the user, aligning with CDSCO’s digital compliance trend.

8. What are the Post‑Marketing Surveillance (PMS) data obligations under Indian medical device regulation?

Short answer: Annual PMS summary reports plus vigilance reporting are mandatory for all licence holders.
Details: PMS ensures ongoing safety and performance monitoring. License holders must submit annual PMS reports and report adverse events or complaints as part of vigilance obligations.

9. How are unlisted devices/components classified under MDR-2017?

Short answer: Submit a classification request with technical dossier and global classification status to the Central Licensing Authority.
Details: For unclear classifications, manufacturers must apply to CDSCO with technical documentation and evidence of international classification to obtain a decision.

10. Can pre-MDR‑2017 validation data be used in the CDSCO medical device registration process?

Short answer: Acceptable if judged satisfactory by the Licensing Authority; no Form MD‑13 test licence needed.
Details: CDSCO may accept legacy data if deemed adequate. In such cases, additional testing or Form MD-13 is not required.

11. Are biocompatibility tests required under CDSCO medical device registration process guidelines?

Short answer: Yes—if the device contacts the body, biocompatibility data per IS/ISO 10993 is mandatory.
Details: Devices that contact the body must have validated biocompatibility data. You may use data from a similar device if you justify it with a biological risk assessment per IS/ISO 10993 standards.

12. Is parametric release allowed for sterile medical devices under MDR-2017?

Short answer: Permitted, provided the sterilisation process is validated (e.g., IS/ISO 11135, 11137‑1, 17665) and routine controls are maintained.
Details: As per MDR-2017 and BIS standards, validated sterilisation (e.g. EO, Gamma, Steam) allows parametric release if routine monitoring and documentation are properly maintained.

13. Is expiry date labeling mandatory for non-sterile devices under Indian medical device regulation?

Short answer: No. CDSCO does not currently require an expiry date on labels of non‑sterile devices.
Details: Labeling for expiry or shelf life is not mandatory for non-sterile devices unless specified otherwise due to risk classification or product-specific guidance.

14. What are the packaging and labeling requirements for devices to be sterilized before use?

Short answer: Label “Non‑sterile—sterilise before use”; package to minimise contamination and be compatible with the intended sterilisation modality.
Details: Such devices must have packaging that resists contamination, labels stating “Non-sterile,” and IFUs that clearly describe sterilisation methods compatible with packaging materials.

15. Is a fresh licence required for change of constitution under CDSCO import license for medical device regulations?

Short answer: Yes. Under the applicable Indian medical device regulations (including MDR-2017 and import rules):
Details: The licensee must inform CDSCO within 30 days and apply for a fresh license within 180 days. Similar timelines apply for registration certificates and manufacturing licenses with 90-day transitional validity.

16. Is a new licence required after changing a manufacturing site under medical device import CDSCO regulations?

Short answer: Yes—apply for a new licence; site change counts as a major variation.
Details: Any change in the manufacturing site requires submission of a fresh license application under MDR-2017, as site location is considered a critical licensing parameter.

17. Do massagers, accessories, and spare parts fall under Indian medical device regulation?

Short answer: Only therapeutic‑claim massagers fall under MDR‑2017; accessories/spare parts follow Medical Devices Grouping Guideline.
Details: Wellness products do not need registration unless marketed for medical/therapeutic purposes. Accessories and parts must be assessed via CDSCO grouping guidelines.

18. Is Software as a Medical Device (SaMD) required to be registered under Indian medical device regulation?

Short answer: Yes, SaMDs are regulated.
Details: Software intended for medical use (e.g. diagnosis, monitoring) must be registered. CDSCO classifies SaMD based on risk and mandates compliance with QMS and labeling norms.

Conclusion

If you still have questions, Morulaa’s FAQ page offers detailed clarifications to help you navigate the CDSCO medical device registration process. Use it as your quick-reference guide to get a better understanding of key steps. Once you’re ready, book a free 15-minute consultation with Morulaa’s regulatory specialists to tackle your next step—whether securing a CDSCO import licence, updating your QMS, or planning Post-Market Surveillance.