India’s Medical Device Regulations (MDR 2017), implemented by the Central Drugs Standard Control Organization (CDSCO), define how medical devices are classified, imported, and registered in the country. This 2025 guide answers key questions from global manufacturers and importers—covering CDSCO licensing, labeling, documentation, and post-market requirements. If you’re looking for the complete overview of how import licensing works, explore our CDSCO import license and medical device registration guide.
These FAQs help clarify medical device regulatory compliance in India, explain medical device regulatory requirements in India, and ensure smooth navigation of Indian medical device regulations. By addressing real-world industry questions, CDSCO makes the medical device approval process in India more transparent and efficient. If you’re specifically looking for import license–related queries, see our dedicated CDSCO Import License FAQ page.
Earlier in 2025, the CDSCO had released two supplementary addenda to its FAQs on the Medical Device Rules, 2017 to provide better clarity on regulatory requirements. Most recently, the Third Addendum (November 2025) has been issued, offering further explanations and updates on key topics such as import licensing, post-approval changes, and documentation procedures.
For manufacturers and importers from the EU, UK, and USA exporting medical devices to India, Morulaa HealthTech provides complete CDSCO regulatory support for registration, licensing, and compliance under MDR 2017.
Addendum No. 01, April 03
- The first update, issued on April 3 (Doc No: CDSCO/FAQ/MD/01/2024 – addendum01, pdf link)
- It address many of the areas where gaps commonly occur such as regulatory procedures, approvals, biocompatibility, site-specific applications, post-market surveillance and compliance requirements.
Addendum No. 02, July 09
- The second supplementary addendum was released on July 9 (Doc No :CDSCO/FAQ/MD/01/2024-addendum 02,pdf link)
- It provides additional clarity in the July update on labelling rules, re-import approvals, software-based device classifications like SaMD and SiMD, post-approval change procedures, and general licensing. These updates make it easier to follow Indian medical device regulations and speed up the approval process.
Addendum No. 03, Nov 03
- The Third Addendum to the CDSCO FAQs on Medical Device Rules, 2017 was released in November 2025 (Doc No: CDSCO/FAQ/MD/01/2025–Addendum 03).
This addendum provides further clarification on various regulatory aspects, including the requirement of import licences for raw materials and components, procedures for post-approval changes, documentation for authorised agents, and import permissions through notified ports. These clarifications aim to simplify compliance, enhance consistency in interpretation, and help manufacturers and importers navigate the Indian medical device regulatory process more effectively.
Together, these three CDSCO 2025 FAQs (addendum) play a critical role in enhancing regulatory transparency and uniformity within India’s fast-evolving medical device sector. They demonstrate CDSCO’s commitment to proactive governance by addressing real-world concerns from industry stakeholders.
CDSCO India Medical Device Regulations Key FAQs 2025 (Addendum 01 & 02):
REGULATORY PATHWAY & LICENSING BASICS IN INDIA
Quick Answers to CDSCO FAQs for India Medical Device Regulations
CATEGORY 01:
Regulatory Pathway & Licensing Basics In India:
(Addendum 01)
Is ISO 13485 certification mandatory under MDR-2017 for the CDSCO medical device regulation process?
Quick answer: Not compulsory, though it adds weight to your QMS proof.
Explanation: No. While ISO 13485:2016 is globally recognized, it is not a mandatory requirement under MDR-2017 to obtain a manufacturing license in India.
Can one application cover multiple manufacturing sites as per medical device import CDSCO regulations?
Quick answer: No. We need to submit a separate Form MD-15 with fees and documents for each site.
Explanation: A separate application, along with requisite fees and documents, is required for each actual manufacturing site, as outlined in medical device import CDSCO regulations.
Can an authorized agent include their brand name in Form MD-14 for a CDSCO import license for medical devices?
Quick answer: Yes, if the brand name appears on the Free Sale Certificate of an approved reference market; otherwise state “Not Applicable.”
Explanation: The brand name must be listed in the FSC issued to the legal manufacturer. If not, “Not Applicable” should be entered in Form MD-14.
Are individual fees required for each brand under the CDSCO medical device regulation process?
Quick answer: CDSCO requires individual fee submissions per brand for manufacturing/import licenses.
Explanation: As per MDR-2017, a distinct fee is required for every brand when applying for either a manufacturing license or an import license.
CATEGORY 02:
CDSCO Export and Import Licensing for Medical Devices
(NEW Addendum 02)
Are export-only devices subject to Indian standards?
Quick answer: Yes, a license is still needed.
Explanation: Devices for export must comply with destination country standards but require Indian licensing too.
Is a Free Sale Certificate (FSC) from USA, UK, EU, Canada, Japan or Australia needed for Class A & B imports?
Quick answer: Yes.
Explanation: If unavailable, submit equivalent documents like safety/performance data and marketing country approval.
Is a Free Sale Certificate USA, UK, EU, Canada, Japan or Australia required for importing medical devices under Class C and D?
Quick answer: Yes.
Explanation: In absence of FSC, Indian clinical evidence and FSC origin-country approval or any other country where the device is being marketed may be accepted.
Is an import license required under MDR, 2017 for bringing in a small quantity of medical devices as a donation to a charitable hospital?
Quick answer: No.
Explanation: These imports are not subject to the provisions outlined in Chapter V of the MDR, 2017. However, an NOC issued by the Central Licensing Authority is necessary to proceed.
CATEGORY 03:
Regulations for Custom-Made & Veterinary Medical Devices
(NEW Addendum 02)
Do you need a test license to conduct evaluation of a custom-made medical device?
Quick answer: No.
Explanation: Custom-made devices do not require a test license for evaluation.
Can a device designed for human use be utilized for veterinary applications as well?
Quick answer: No.
Explanation: Veterinary-use devices must obtain a separate license under MDR, 2017 from the Licensing Authority specifically for veterinary applications.
What is meant by a custom-made medical device?
Quick answer: A device made specifically for one patient based on a registered medical practitioner’s written prescription.
Explanation: As per Rule 3(r) of MDR, 2017, it is designed under the practitioner’s responsibility for a single patient’s use, and does not include mass-produced devices.
Is a license necessary under MDR, 2017 to manufacture or import custom-made medical devices for marketing in India?
Quick answer: No.
Explanation: Custom-made medical devices are not covered by the requirements stated in Chapters IV and V of the MDR, 2017. However, the manufacturing facility must comply with quality management system requirements and applicable labelling rules.
Are bulk-manufactured or imported devices that are customized for a user also exempt?
Quick answer: No.
Explanation: Devices produced in bulk that only require adaptation for a practitioner’s or professional user’s specific needs are not considered custom-made. Such products require a license for marketing in India.
Can veterinary medical devices be approved if they are not authorized by the national regulators of the USA, UK, EU, Canada, Japan, or Australia?
Quick answer: Yes, with conditions.
Explanation: If approval from the listed national regulatory authorities is not available, the applicant may submit marketing approval from another competent authority in these countries.
Is a No Objection Certificate (NOC) from the Department of Animal Husbandry and Dairying (DAHD) required for all veterinary medical devices before licensing?
Quick answer: No.
Explanation: The NOC from DAHD is applicable only in cases where a veterinary medical device does not have a previously approved predicate device.
CATEGORY 04:
Medical Device Licensing Process/ Wholesale & CDSCO Fees
(Addendum 01)
Is a wholesale license necessary for Class A (non-sterile and non-measuring) devices under Indian medical device regulations?
Quick answer: Correct — no Form 20B/21B or MD-42 is required.
Explanation: Non-sterile, non-measuring Class A devices are exempt from sales licensing under Chapter XI of MDR-2017.
(NEW Addendum 02)
What documents are necessary to obtain an NOC for importing donated medical devices?
Quick answer: Hospital registration proof, shipment details, and necessary undertakings.
Explanation: The application must include the hospital/trust’s registration certificate, Bill of Entry/Bill of Lading/Invoice, an undertaking confirming free distribution to patients, and another accepting responsibility for any safety issues.
What is needed to become an authorized agent for medical device imports ?
Quick answer: A valid wholesale, or manufacturing license.
Explanation: The agent must hold a Form 20B/21B wholesale license, a Form MD-42, or a manufacturing license under MDR, 2017.
Is a QMS required for Class A non-sterile, non-measuring devices?
Quick answer: Yes.
Explanation: The manufacturing facility must comply with QMS requirements even for these low-risk devices.
Does changing the sterilization method make it a different device?
Quick answer: Yes.
Explanation: The existing license must be updated with an endorsement to reflect the change as per MDR, 2017.
Must the intended use in a license application match CDSCO’s classification list exactly?
Quick answer: Not exactly, but it must remain consistent in purpose.
Explanation: The wording can vary, but the intended use must align with the core description; significant changes may alter risk classification.
Can devices made/imported under a Test License be sold commercially?
Quick answer: No.
Explanation: These devices are limited to testing, evaluation, or training, and unused stock must be exported or destroyed with CLA approval.
Can the risk class in a Test License be used for market authorization?
Quick answer: No.
Explanation: The risk class in a Test License is only provisional. Applicants must verify the official classification before market authorization.
How to obtain a Neutral Code for a medical device?
Quick answer: Apply through the CDSCO online portal.
Explanation: A licensed manufacturer can submit a request via the Medical Devices Online Portal to the CLA.
How to obtain a Market Standing Certificate or Non-Conviction Certificate for Class C & D devices?
Quick answer: Apply through the CDSCO online portal.
Explanation: The application for a Market Standing Certificate or Non-Conviction Certificate for Class C and D devices must be submitted online through the CDSCO Medical Devices Portal, along with the required details and supporting documents for verification. Applicants are generally expected to provide information such as valid manufacturing or import licenses, product details, proof of market presence, and undertakings related to compliance. Once uploaded, the system generates the certificate digitally, ensuring faster processing and easier access for future regulatory submissions. Applications can be made directly via the CDSCO Medical Devices Online Portal.
How to register a testing lab for medical device testing?
Quick answer: Follow Chapter X of MDR, 2017 and meet accreditation standards.
Explanation: The lab must have NABL accreditation, comply with ISO/IEC 17025, and obtain a medical device certificate under Chapter X.
How can the fees for obtaining a license under MDR, 2017 be paid?
Quick answer: By challan or electronic transfer.
Explanation: Payments must be made to the Licensing Authority and uploading the payment receipt is recommended.
CATEGORY 05:
Miscellaneous
(NEW Addendum 02)
Are all beauty care devices for human use regulated under MDR, 2017?
Quick answer: No.
Explanation: Beauty care equipment is not covered under MDR, 2017 if it is not intended for therapeutic use or for altering the anatomy or physiological functions of the human body.
Can a new application for Registration of a Notified Body (for auditing Class A & B devices) be submitted via the MD Online Portal?
Quick answer: No.
Explanation: Such applications must be submitted in Form MD-1 via the National Single Window System (NSWS) at (https://www.nsws.gov.in/).
How can an applicant request a waiver of an additional condition mentioned in the permission/license for Class C & D devices under MDR, 2017?
Quick answer: Through the MD Online Portal.
Explanation: An applicant seeking a waiver of an additional condition in the permission or license for Class C & D medical devices under MDR, 2017 must apply through the Medical Devices Online Portal (MD Online Portal) of CDSCO. The waiver request is submitted electronically by selecting the relevant feature on the portal and providing:
A written justification explaining why the specific condition should be waived.
- Supporting documents such as clinical evidence, safety data, performance evaluations, or reference country approvals (if applicable).
- Any additional information required by the Central Licensing Authority (CLA) for review.
Once uploaded, the request is processed and tracked online until a decision is communicated by the authority.
CATEGORY 06:
Digital Documentation & Post-Market Surveillance In India
(NEW Addendum 02)
Can e-IFUs be used under the India’s medical device regulations?
Quick answer: Yes, if identical to the paper IFU and accessible at the point of use.
Explanation: e-IFUs are acceptable provided they match the printed version in content and can be accessed when needed.
What are the PMS data requirements under Indian regulations?
Quick answer: Annual PMS summaries and vigilance reporting are mandatory.
Explanation: Post-Market Surveillance ensures ongoing safety monitoring, requiring annual reports and prompt adverse event reporting.
CATEGORY 07:
Medical Device Classification & Data Acceptance Under CDSCO Rules
(Addendum 01)
How are unlisted devices/components classified under MDR-2017?
Quick answer: Provide a classification application with technical details and global classification data.
Explanation: CDSCO will determine the category based on documentation and international classification proof.
Can previously generated validation data, before the introduction of MDR-2017, be accepted as per CDSCO’s regulations?
Quick answer: Yes, if approved by the Licensing Authority and no new test license is required.
Explanation: CDSCO may accept older validation data if it meets their standards. In such cases, further testing or obtaining a Form MD-13 is unnecessary.
CATEGORY 08:
Testing, Sterilization & Biocompatibility Standards
(Addendum 01)
Does CDSCO require biocompatibility testing as per MDR 2017 regulations?
Quick answer: Yes—if a device comes into contact with the human body, biocompatibility data in line with IS/ISO 10993 is required.
Explanation: For any device that touches the body, validated biocompatibility evidence must be provided. Data from a comparable device may be submitted if supported by a biological risk assessment in accordance with IS/ISO 10993.
Under MDR, 2017, is it permissible to use parametric release for sterile devices
Quick answer: Yes, if the sterilization method is validated (e.g., IS/ISO 11135, 11137-1, 17665) and routine process controls are in place.
Explanation: According to MDR-2017 and BIS standards, parametric release is acceptable for validated sterilization methods such as EO, Gamma, or Steam, provided ongoing monitoring and complete documentation are maintained.
CATEGORY 09:
Labelling, Packaging & IFU Requirements for Medical Devices in India
(Addendum 01)
Is it necessary to include an expiry date on labels of non-sterile medical devices in India?
Quick answer: No. As per CDSCO guidelines, non-sterile devices are not required to carry an expiry date on their labels.
Explanation: Shelf life or expiry information is generally not mandatory for non-sterile devices unless specified in product-specific guidelines or required due to their risk classification.
What are the labelling and packaging guidelines for devices that need sterilization prior to use?
Quick answer: Labels should clearly state “Non-sterile—sterilize before use,” and the packaging must prevent contamination and be compatible with the chosen sterilization method.
Explanation: Devices intended for sterilization prior to use must be sealed in contamination-resistant materials, display a “Non-sterile” label, and include Instructions for Use (IFU) detailing the sterilization process suitable for the packaging materials.
(NEW Addendum 02)
Do components or accessories of a medical device require licensing under MDR, 2017?
Quick answer: Yes, if they meet the definition of a medical device under Indian regulations.
Explanation: Any accessory or component that qualifies as a medical device under S.O. 648(E) dated 11.02.2020, and is commercially sold in labelled or packaged form, must obtain a valid license in accordance with MDR, 2017.
CATEGORY 10:
License Changes & Manufacturing Site Updates
(Addendum 01)
Is a fresh license required if the company’s constitution changes under CDSCO’s medical device import rules?
Quick answer: Yes, this requirement falls under MDR-2017 and associated import provisions.
Explanation: In the event of a change in the legal constitution of the company, the license holder must inform CDSCO within 30 days and apply for a new license within 180 days. During this period, the current license remains valid for up to 90 days, and the same process applies to regulatory certificates and manufacturing licenses. This ensures that regulatory accountability is maintained with the new legal entity. Applicants should also update supporting documents, such as company incorporation records and authorizations, to avoid delays or compliance issues.
Is a fresh license necessary after changing the manufacturing site under CDSCO’s medical device import rules?
Quick answer: Yes—a new application must be filed, as a site change is treated as a significant variation.
Explanation: Relocating the manufacturing site requires obtaining a new license under MDR-2017, since site details are a critical part of the licensing requirements.
CATEGORY 11:
Product Scope & Software as a Medical Device (SAMD)
(Addendum 01)
Do massagers, spare parts, and accessories fall under Indian medical device regulations?
Quick answer: Only massagers marketed with therapeutic claims are governed under MDR-2017, while accessories and spare parts are subject to regulation as per CDSCO’s Medical Device Grouping Guidelines.
Explanation: General wellness massagers do not come under regulations unless promoted for medical or therapeutic purposes. Accessories and spare parts are evaluated in line with CDSCO’s grouping criteria.
Do Software as a Medical Device (SaMD) products need to be registered under Indian medical device regulations?
Quick answer: Yes, SaMDs are subject to regulation.
Explanation: All software designed for medical use—such as in diagnosis, monitoring, or treatment—are regulated under the applicable Rules. CDSCO assigns SaMD classifications based on risk level and requires adherence to quality management system standards and labelling requirements.
(NEW Addendum 02)
Is a Batch Release Certificate or Certificate of Analysis for three consecutive batches required for Software as a Medical Device (SaMD) and medical equipment?
Quick Answer: Not necessarily — software-based and certain equipment can provide alternative release documentation.
Explanation: For these types of devices, applicants may submit a final software release certificate or a factory release certificate confirming that the product meets all applicable specifications. This should be accompanied by a clear justification explaining why traditional batch release or three-batch analysis is not applicable.
CATEGORY 12:
Addendum 03 – Key Points
Do the Power of Attorney (PoA) signed by the manufacturer and the undertaking signed by the authorized agent need to be combined into a single bound document after apostille or authentication (either in the country of origin or in India)?
Quick answer: Yes.
Explanation: Both documents must be submitted together as one properly bound or punched set.
If the name of the actual manufacturing site changes, but the company’s ownership or constitution remains the same, is a new license required?
Quick answer: No.
Explanation: In such cases, the firm must apply for approval from the licensing authority through a Post-Approval Change process.
Is an AERB type-approval or compliance certificate required before getting an import or manufacturing License for ionizing -radiation medical devices in India?
Quick answer: No.
Explanation: It is not compulsory at the licensing stage. However, the applicant must provide the relevant AERB approval to the licensing authority before the device is used on patients within India.
- Note: The above provides a brief overview of the FAQs. For full regulatory details and official guidance, please refer to the original CDSCO notice and its corresponding addendum.
Conclusion: This article offers a clear and simplified overview of the CDSCO FAQ 2025 updates, enabling manufacturers to better understand India’s evolving medical device regulatory requirements. It outlines key aspects of medical device regulatory compliance in India, updated processes for licensing, labelling requirements, re-imports, and post-market surveillance. By adhering to Indian medical device regulations, manufacturers and importers can speed up approvals, maintain audit preparedness, and contribute to safer, more effective healthcare services.
To understand how these MDR steps fit into the broader CDSCO import process, you can refer to our comprehensive guide on CDSCO import license and medical device registration in India. If you have further questions about navigating the CDSCO medical device regulations, our FAQ section provides in-depth answers to common regulatory queries. It also includes a step-by step medical device registration overview to help you understand licensing, documentation, and compliance timelines under Indian medical device regulations.
Connect with Morulaa’s regulatory experts for a free 15-minute consultation and get actionable support on the IVD/Medical Device import registration India process, ISO 13485 compliance, or post-market surveillance—ensuring fast, audit-ready medical device regulatory compliance in India. The Indian medical device import process involves getting CDSCO approval, submitting required documents like quality certificates and technical details, paying the fees, and following all compliance steps so the devices can be legally brought into India and sold.