These FAQs are meant to create public awareness about the medical device approval process in India as regulated by CDSCO. For professional or legal advice, please consult the Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017, along with official CDSCO guidelines. There are some of the FAQ’s which have been published recently and some of them which have been updated from the previous FAQ posted.Â
New FAQ’s PublishedÂ
1. Whether the manufacturer or importer needs to conduct the Biocompatibility test on all applied products?
Biocompatibility is required for devices that come in direct or indirect contact with the human body. The manufacturer must generate the Biocompatibility data on the applied device as per applicable standards. These tests must be conducted as part of material validation and should be revalidated if there are changes in the material, process, or supplier.
The Biocompatibility testing of medical devices must be performed as per IS/ISO 10993 series standards. If the manufacturer has already conducted Biocompatibility testing for a similar device (same category, manufacturing process, and raw material suppliers), they may submit that data for the current application with proper justification and a biological risk assessment report.
If the material is used in a device with different invasiveness, additional testing is required as per ISO 10993-1. Manufacturers must also perform “for cause” testing in response to reported adverse events or trending complaints.
2. Whether the manufacturer can release the sterile medical device to the market based on parametric release?
Yes. As per Clause 7.5.2.2 of the Fifth Schedule of the Medical Devices Rules, 2017, which defines the Quality Management System (QMS) for medical device approval in India, the manufacturer must validate the sterilization process before initial use.
Under Rule 7 of MDR, 2017, manufacturers must comply with Bureau of Indian Standards (BIS), or if unavailable, ISO/IEC/Pharmacopoeial standards. If no recognized standard exists, a validated internal manufacturer’s standard may be used.
BIS has standards for sterilization validation processes, such as:
- Ethylene Oxide: IS/ISO 11135
- Gamma Radiation: IS/ISO 11137-1
- Steam Sterilization: IS 17812 (Part 1)/ISO 17665
These standards allow parametric release under routine control. If validated and maintained, manufacturers can release sterile devices per the requirements in those standards — a core aspect of the CDSCO medical device registration process.
3. Whether for a medical device supplied in a non-sterile state, the expiry/shelf life is mandatory on its label?
No. For a non-sterile medical device, the date of expiry or shelf life on the label is not mandatory under current CDSCO labeling guidelines.
4. Whether validation and QC data generated prior to MDR-2017 can be considered for a manufacturing license?
Yes. 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 medical device approval process in India for legacy products.
5. In case of a change of constitution of the company/firm holding the import license under the MDR-2017, whether a fresh license is required?
Yes. The licensee must inform the Central Licensing Authority in writing within 30 days and apply for a new license within 180 days of the change. The current license remains valid until the new one is issued or rejected. This process is essential for maintaining a valid CDSCO import license for medical devices.
6. In case of Change of constitution of the company/firm holding the registration certificate under the MDR-2017, whether fresh registration is required?
Yes. The registration holder must notify the Central Licensing Authority. The current registration remains valid for 90 days from the date of change, unless a new registration is issued sooner.
7. Can the applicant submit a single application for multiple manufacturing sites to obtain an import license?
No. A separate application, along with requisite fees and documents, is required for each actual manufacturing site. This is mandatory under the CDSCO import license for medical devices protocol.
8. What is a non-sterile medical device?
A non-sterile medical device is one that is intended by the manufacturer to be supplied in a non-sterile condition.
9. What are the packaging and labeling requirements for non-sterile devices to be sterilized before use?
If a device is intended to be sterilized before use:
- The label must clearly state that the device is in a “non-sterile” state.
- Packaging must minimize microbial contamination.
- The packaging must be suitable for the intended sterilization method.
- Instructions for use must specify the sterilization method to be used before end-use.
10. What is a sterile medical device?
A sterile medical device is intended by its manufacturer to be supplied in a sterile state. The label must indicate its sterility and the sterilization method. It must be produced and packaged in a way that ensures sterility until the packaging is opened or damaged.
11. Is a wholesale license in Form 20B/21B or registration in Form MD-42 mandatory for Class A (non-sterile, non-measuring) devices?
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.
12. What is the regulatory pathway for medical device manufacturing or import under MDR-2017?
CDSCO provides a detailed regulatory framework covering the complete CDSCO medical device registration process, including development, testing, approval, and post-market compliance.
You can view the official document here:
đź”— CDSCO Medical Device Regulatory Pathway (PDF)
13. Is ISO 13485:2016 certification required for a manufacturing license?
No. While ISO 13485:2016 is globally recognized, it is not a mandatory requirement under MDR-2017 to obtain a manufacturing license in India.
14. In case of import, can an Indian authorized agent use their brand name in Form MD-14?
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.
15. In case of a change of constitution of the company, whether a fresh license is required?Â
| Answer as per old FAQ | Answer as per new FAQ |
| Yes, the applicant shall inform the Licensing Authority about such change within 45 days and submit an application under MDR-2017 within a period of 180 days from the date of such change in constitution. | Yes. The licensee shall inform the Licensing Authority about such change within 45 days and submit an application under MDR-2017 within a period of 180 days from the date of such change in constitution. In such cases, the existing licence shall be deemed to be valid till such time, a fresh licence is issued or application is rejected by the Licensing Authority. |
16. In case of change in the location of the manufacturing site of the manufacturer whether a fresh license is required?Â
| Answer as per old FAQ | Answer as per new FAQ |
| In such cases, the applicant has to inform to the Licensing Authority through Post approval changes (notification), thereafter, necessary approval is required to be obtained from the Licensing Authority as per the requirement. | Yes. A fresh manufacturing license must be obtained under MDR-2017 for any change in manufacturing location. |
Conclusion
This FAQ covers key aspects of the medical device approval process in India, including regulatory requirements, CDSCO procedures, and compliance under MDR-2017. If you’re looking for help with:
- Applying for a CDSCO import license
- Navigating the medical device registration process
- Understanding MDR-2017 compliance requirements
Our regulatory experts are here to guide you every step of the way.