1. Regulatory pathway under MDR‑2017

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 13485:2016 certification required for manufacturing licence?

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. One application for multiple manufacturing sites?

Short answer: No. Submit a separate Form MD‑15 with fees and documents for each site.

Details: 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.

4. Can an authorised agent use their brand name in Form MD‑14?

Short answer: Yes, if the brand name appears on the Free Sale Certificate of an approved reference market; otherwise state “Not Applicable.”

Details: 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.

5. Separate fees for each brand

Short answer: CDSCO requires individual fee submissions per brand for manufacturing/import licences.

Details: 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. Moreover, the process for acquiring an Import License for various purposes, including clinical investigations and testing, is detailed in Form MD-17, highlighting the three-year validity of licenses issued under this form.

6. Wholesale licence exemption for Class A (non‑sterile, non‑measuring)

Short answer: Correct—no Form 20B/21B or MD‑42 required.

Details: 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.

7. Electronic Instructions for Use (e‑IFU)

Short answer: Permitted if the e‑IFU is identical in content to the paper IFU and accessible at point of use.

Details: 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.

8. Post‑Marketing Surveillance (PMS) data obligations

Short answer: Annual PMS summary reports plus vigilance reporting are mandatory for all licence holders.

Details: 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. For devices or components not covered in the existing risk classification, manufacturers can request a classification from the Central Licensing Authority, providing detailed technical documents and international regulatory status.

9. Classification of devices/components not listed in MDR‑2017

Short answer: Submit a classification request with technical dossier and global classification status to the Central Licensing Authority.

Details: 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.

10. Using pre‑MDR‑2017 validation & QC data

Short answer: Acceptable if judged satisfactory by the Licensing Authority; no Form MD‑13 test licence needed.

Details: Yes, as per 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.

11. Biocompatibility testing requirements

Short answer: Yes—if the device contacts the body, biocompatibility data per IS/ISO 10993 is mandatory. You may reference previous testing for an identical device, provided you justify equivalence via a biological risk assessment.

Details: As per the CDSCO medical device registration process, 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 as per  Indian medical device regulation. Manufacturers must also perform “for cause” testing in response to reported adverse events or trending complaints. 

12. Parametric release for sterile devices

Short answer: Permitted, provided the sterilisation process is validated (e.g., IS/ISO 11135, 11137‑1, 17665) and routine controls are maintained.

Details: 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.
As per the Indian medical device regulation  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 as per the CDSCO medical device registration process. If validated and maintained, manufacturers can release sterile devices per the requirements in those standards.

13. Is expiry/shelf‑life mandatory for non‑sterile devices?

Short answer: No. CDSCO does not currently require an expiry date on labels of non‑sterile devices.

Details: 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. 

14. Packaging & labelling for devices to be sterilised before use

Short answer: Label “Non‑sterile—sterilise before use”; package to minimise contamination and be compatible with the intended sterilisation modality.

Details: 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.

15. Change of constitution – Import licence, registration certificate, and manufacturing licence

Short answer: Yes. Under the applicable Indian medical device regulations (including MDR-2017 and import rules):

• For import licences, the licensee must inform the Central Licensing Authority (CDSCO) within 30 days of the change in constitution and apply for a fresh licence within 180 days. The existing import licence remains valid until the new one is issued or the application is rejected.
• For registration certificates, the registration holder must notify the authority within 45 days and apply within 180 days. The current certificate remains valid for 90 days from the date of change, unless a new certificate is issued sooner.
• For manufacturing licences, the licensee must notify the Licensing Authority within 45 days and apply under MDR-2017 within 180 days. The existing licence remains valid until a fresh licence is issued or the application is rejected.

16. Fresh licence required after relocating manufacturing site?

Short answer: Yes—apply for a new licence; site change counts as a major variation.

Details: Yes. A fresh manufacturing license must be obtained under MDR-2017 for any change in manufacturing location.

17. Massagers, accessories & spare parts

Short answer: Only therapeutic‑claim massagers fall under MDR‑2017; accessories/spare parts follow Medical Devices Grouping Guideline.

Details: Massagers designed solely for relaxation or wellness do not fall under the Medical Devices Rules, 2017, unless they are explicitly marketed for therapeutic uses, such as disease alleviation. This distinction is critical for manufacturers to understand when determining the regulatory pathway for their products. Companies looking to market their massagers for therapeutic purposes must ensure compliance with the rules, a process where Morulaa’s expertise can significantly aid in obtaining the necessary CDSCO regulatory approval.

18. Do Software as Medical Device need to be registered? 

Short answer: Yes, SaMDs are regulated

Details: SaMD, or standalone software that functions as a medical device, is subject to specific regulatory requirements, including labeling. Manufacturers must adhere to these requirements to ensure their products can be legally marketed in India. Morulaa can provide guidance on the intricacies of these regulations, ensuring that SaMD products meet all necessary standards for approval.