Your Strategic Partner For Regulatory Compliance
+91 9306468090 | mdrconsultants.in@gmail.com

Frequently Asked Questions

Yes, as per the notification S.O. 648 (E) dated 11.02.2020, all Medical Devices are regulated under the Medical Devices Rules, 2017.
No. Consequent to the implementation on the notification G.S.R. 102 (E) dated 11.02.2020, all Medical devices are under the licensing regime (except for Class A (non-sterile and non-measuring) medical devices) and license is required for the import/manufacture of Medical devices in the country. The registration number obtained by the applicant shall not be considered as a regulatory approval for the manufacture/import of devices in the country.
The copy of the Medical Devices Rules, 2017 and its amendments are available in the CDSCO Website (www.cdsco.gov.in).
Yes.
The Drugs Controller General (India) is the Central Licensing Authority for Medical Devices in India. 
Address: 
Central Drugs Standard Control Organization (CDSCO), 
Directorate General of Health Services,
Ministry of Health and Family Welfare, 
Government of India, 
FDA Bhavan, ITO, Kotla Road, New Delhi -110002
The responsibility of the CLA and SLA under the MDR-2017 are as under:
Central Licensing Authority (CLA)

State Licensing Authorities (SLA)
Enforcement of rules in matters related to:Enforcement of rules in matters related to:
• Import of all classes of Medical Devices• Manufacture for sale or distribution of Class A or Class B Medical Devices
• Manufacture of Class C and Class D Medical Devices• Sale, stock, exhibit or offer for sale or distribution of Medical Devices of all classes
• Clinical investigation and approval of Medical Devices that do not have a predicate device
• Registration of Notified Bodies
• Registration of laboratories for carrying out test or evaluation
• Grant of test licences for manufacture or import of all classes of Medical Devices
• Risk-based classification of Medical Devices
Yes. The Public Relation Office (PRO) cell is established in CDSCO Head Quarter to address the issue of startups/ innovators/ importers/ manufacturers in the field of Medical devices pertaining to regulatory pathway. 

Link: https://cdsco.gov.in/opencms/opencms/en/PRO/;
Email ID: startupinnov@cdsco.nic.in
The applicant is required to submit their application through online mode for which specific provision for submission of application is available as under:
Website link: www.cdscomdonline.gov.in , www.nsws.gov.in
The contents of PMF/SMF have been prescribed in Appendix - I of Fourth Schedule of MDR-2017. 
Yes
Only authorized person of the company can ask the status of their application.
The essential documents shall be submitted as per the checklist available in the Medical Devices Online portal under Medical Devices Rules, 2017.
The Fee required to be submitted for various applications is prescribed in the Second Schedule of Medical Devices Rules, 2017. 
As per Medical Devices Rules, 2017, there is no provision/ clause for the refund of the fee paid by the applicant. 
Yes, a separate fee is required to be submitted for each applied Brands of a device as per Second Schedule of MDR-2017.
Yes, the manufacturers may send their devices for test or evaluation to the Medical Device Testing Laboratory (MDTL) registered with CDSCO under MDR-2017. A list of the registered MDTL is published on CDSCO website which is dynamic in nature.
An endorsement application along with requisite fees and requisite documents as per Fourth Schedule of MDR-2017 & checklist available in the Medical Devices Online portal.
Under MDR-2017, the License for Manufacture is issued in Form MD-13 and License for Import is issued in Form MD-17 for the purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training.
No, the licence is issued with the validity of three years from the date of issue of the license under MDR-2017. 
Central medical devices testing laboratory (CMDTL) means a medical devices testing laboratory established or designated by the Central Government under rule 19 of MDR-2017.
The Change of constitution is defined under Rule 3(j) of MDR-2017 as under: 
o a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa; 
o a company means- (A) its conversion from a private to a public company, or from a public to a private company; or (B) any change in the ownership of shares of more than fifty per cent. Of the voting capital in the body corporate or in case of a body corporate not having a share capital, any change in its membership; and where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change in the constitution of that other body corporate within the meaning of this clause;
Yes, the applicant shall inform to 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.
Only those Notified body who are registered with the CDSCO are eligible for audit the manufacturing facility of Class A & Class B medical devices in the country.
The list of Notified bodies registered with CDSCO is available on the CDSCO website. The list is dynamic in nature.
If the BIS standard is available for the particular medical device, then in such cases, the fulfilment of BIS standard is mandatory. In case, there is no BIS standard available, then other international standards (ISO/IEC) would be applicable.
 In such cases, the medical device shall conform to any other pharmacopoeial standards or validated manufacturers standard. 
For Class C and Class D medical device, the inspection will be carried out by the Medical Device Officers within a period of 60 days from the date of application, provided the data submitted by the applicant is found satisfactory.
The medical device when offered for sale as single or multi pack, shall be accompanied by either its IFU (Instructions for use), prescribing information, relevant literature, etc.
Yes.
It is the responsibility of the licensed holder for the submission of Post Marketing Surveillance (PMS) data to the Licensing Authority.
Product labels shall comply with the Labelling requirements as prescribed in Chapter VI of Medical Devices Rules, 2017. 
The date of expiry shall be in terms of the month and the year. 
The Residual shelf life for the medical devices is specified in Rule 47 of MDR-2017.
A real-time aging data shall be submitted to support the claimed shelf life. However, if real-time data is not available, accelerated stability data shall be submitted to support the claimed shelf life. Such a provisional claimed shelf life may be approved provided that the manufacturer immediately initiates real-time stability testing to validate the proposed shelf life and the real-time stability data shall be submitted after completion of the study by the manufacturer.
A real-time aging data of the medical device generated by the manufacturer along with the accelerated stability data and other relevant supporting data shall be submitted to support the claimed shelf life beyond 5 years. 
In case of Medical Equipments/Instruments/Apparatus, the date of expiry may not be necessary, however, the applicant may mention use life of such device in the Technical dossier.
The accelerated stability study data can be considered provided the applicant submits the on-going real-time stability study data initiated at the time of accelerated stability study and the detailed real time stability study data shall be submitted after completion of the study to the Licensing authority.
Yes. The changes in respect of label excluding change in font size, font type, color, label design shall be considered as major change as per Sixth Schedule of MDR-2017.
Under the Medical Devices Rules, 2017, the applicant needs to comply with the requirements of the Quality Management System (QMS) in respect of the manufacturing of Medical devices
No. The WHO GMP certificate is generally issued for drug formulations based on the WHO guidelines. However, for any certificate required for export purpose, the Licensing authority may consider for issuance of necessary certificate for this purpose under MDR-2017.
The Licensing Authority who has issued license may issue such certificates.
The Market Standing Certificate issued by the Licensing Authority is valid for a period of one year from the date of issuance of the certificate.
Free Sale Certificate issued by the Licensing Authority is valid upto the validity of the manufacturing licence.
There is no provision in MDR-2017 for issuance of GLP certificate. However, the testing lab shall conform to the requirements of Laboratory Quality Management System (LQMS).
As regard to ensuring the quality of components/ raw materials to be used for further manufacturing of finished medical devices, it is required that manufacturer of these components need to qualify product standards and Quality Management System.
The Environmental requirements for certain category of medical devices are prescribed in Annexure A of the Fifth Schedule of MDR-2017. For other medical devices which are not specified in the Annexure A, the manufacturer shall adhere the applicable standards/norms for such manufacturing activities.
Yes. If the applicant intends to send the medical device to different testing centers, they may submit single test license application by mentioning each testing site along with the quantity to be tested at each site.
For this purpose, the Grouping Guidelines for Medical Devices Applications is published by the Ministry of Health & Family Welfare, Government of India which is available in CDSCO website.
No.
The applicant shall submit a comparative statement/document between applied product and predicate device in respect to the name and address of the manufacturer, intended use, risk class, Material of construction, applicable standards, design characteristics, energy used or delivered, manufacturing and testing process, biocompatibility, performance, safety, effectiveness other characteristics etc (as applicable) as per Rule 51 of MDR-2017. 
If the massager is intended for soothing or general wellness purpose and not for any therapeutic purpose, then it does not come under the regulation. However, if it is intended for the purpose like therapeutic, alleviation of disease or disorder, etc. are regulated under the provisions of Medical Devices Rules, 2017.
The applicant may submit all such applications through Online mode in Medical Devices online portal (www.cdscomdonline.gov.in) to concerned Licensing Authority.
The fee as specified in Second Schedule of MDR-2017 is payable to the State Licensing Authority, through a challan or by electronic mode as may be specified by the State Government concerned.
No.
Import License, Manufacturing License or Registration certificate issued under MDR-2017 shall continue to be perpetually valid till suspension or cancellation, provided that the licencee/registration holder shall pay a Licence/ Registration retention fee in every five years under the provisions of MDR- 2017.
The endorsement license issued by the Licensing Authority is valid till the date of validity of its base license.
Only those disinfectants which are intended for the disinfection of Medical devices are regulated under the Medical Devices Rules, 2017.
The devices which attracts the definition as per S.O. 648(E) dated 11.02.2020 are regulated under the Medical Devices Rules, 2017 and a license is required under the said rule.
In such cases, the applicant may obtain Test licence in Form MD-13 for manufacturing of test batches or obtain Test licence in Form MD-17 for the import of small quantity of devices under the provisions of Medical Devices Rules, 2017. 
An ‘Accessory’ means a device which attracts the definition of device as per S.O. 648 (E) dated 11.02.2020. 
Such accessory shall be intended specifically by its manufacturer to be used together (in combination) with a particular medical device (parent) to enable or assist that medical device (parent) to be used in accordance with its intended use
Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.
Spare parts refer to component or part of a medical device, specifically intended to replace an identical or similar integral part or component of a medical device that is defective or worn in order to maintain or restore the function of the medical device without changing its performance or safety characteristics or its intended use and which does not adversely affect the safety and performance of the device.
If such component or part of a medical device, changes the performance or safety characteristics or the intended purpose of the medical device, then it shall be considered to be a medical device and shall meet the requirements laid down the Medical Devices Rules, 2017.
At the time of submission of application, the applicant may follow the Medical Devices Grouping Guideline for requisite fee and submit requisite documents of the main device(s).
Accessories or components which are clearly defined in the Device master file as a part of the main device(s) and also in its Instruction for use, are only to be listed under the application for manufacturing/import license.
The Eighth Schedule prescribes the exemptions for certain provisions for Medical devices under MDR-2017. 
The Central Government may, by notification, from time to time, amend or modify the entries in the Eighth Schedule. 
The conditions of the License/ permission issued by the Licensing Authority is mentioned in the respective rules under MDR-2017 and also mentioned in the covering letter issued along with the License/ permission.
Yes. Standalone software which attracts the definition of device as per S.O. 648 (E) dated 11.02.2020 are regulated under the Medical Devices Rules, 2017.
Software which attracts the definition of device as per S.O. 648 (E) dated 11.02.2020 are regulated under the Medical Devices Rules, 2017
No. Class A (non-sterile and non-measuring) medical devices are exempted from the requirements of Chapter IV, V, VII, VIII and XI of Medical Devices Rules, 2017.
However, the applicant has to do mandatory registration through Medical Devices Online portal and comply with the labeling requirements prescribed in Chapter VI of MDR-2017 & applicable standards.
A system generated registration number for a Class A (non-sterile and nonmeasuring) medical device is obtained after furnishing of the requisite information on the Medical Devices online portal.
No
Any medical device which is intended by the manufacturer to measure quantitatively a physiological or anatomical parameter or measure a quantity or a quantifiable characteristic of energy or of substances (including medicinal products) delivered to or removed from the human body and the result of the measurement is displayed in legal units or other acceptable units of measurement, by the device is considered as a measurable medical device.
As the control of Class A medical devices is under the State Licensing Authority, therefore the applicant may approach to the concerned State Licensing Authority for obtaining such certificates.
The parameters for risk based classification for Medical devices are prescribed in Part I of the First Schedule of MDR-2017, as under :— 
a. low risk - Class A; 
b. low moderate risk- Class B; 
c. moderate high risk- Class C; 
d. high risk- Class D
As per Rule 3 of MDR-2017, the Central Licensing Authority classifies medical devices based on their intended use and other parameters specified in the First Schedule of Medical Devices Rules, 2017. 
Risk-based classification list of medical devices are published on the website of the Central Drugs Standard Control Organization (CDSCO). The Central Licensing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device. 
CDSCO has already displayed the list of medical devices with risk classification, which is dynamic in nature. 
Please refer to the Risk-based classification list issued by Central Licensing Authority available in CDSCO website.
Only the Central Licensing Authority under MDR, 2017 is the competent authority to classify the medical devices as per the risk-based parameters specified in the First Schedule of MDR-2017.
The applicant may submit separate request to Central Licensing Authority along with the product technical documents (label and IFU), regulatory status of the product / similar product in the other countries to classify the devices and same will be conveyed to the applicant and the existing risk classification list will be updated accordingly.
Yes.
The applicant may submit the application to the Licensing authority through online portal as under: 
o For Class A (other than non-sterile and non-measuring) medical device & Class B Medical Devices - approach the State Licensing Authority under whose jurisdiction, the manufacturing premises is located. 
o For Class C & Class D Medical Devices - Central Licensing Authority.
For Indigenous manufacturers of Medical Devices: 
(i) For Class A (other than non-sterile and non-measuring) medical device, no audit of the manufacturing site shall be necessary prior to grant of licence or loan licence to manufacture for sale or for distribution; and 
(ii) For Class B, Class C and Class D medical devices, before grant of the manufacturing licence the audit/inspection of the manufacturing site shall be carried out.
Loan licence means a licence issued by the State Licensing Authority or the Central Licensing Authority, for manufacturing a medical device, as the case may be, to a person who intends to utilize the manufacturing site of other licencee for manufacturing the same medical device as manufactured by the licencee at that site.
No. The Notified body which is registered with the CDSCO for the purpose will be assigned by the concerned State Licensing Authority after review of the online applications.
In such cases, the notified body shall inform the scope of their audit to the concerned State Licensing Authority inorder to designate the alternate Notified body for the QMS verification.
Yes, the manufacturer shall submit an undertaking signed stating that their manufacturing site is in compliance with the provisions of the Fifth Schedule of MDR-2017.
The Central Licensing Authority approves the Neutral code/ Special code number for export purpose in respect of all the classes of medical devices.
Yes, the applicant shall mention the term “For Export only” under the Generic name of the medical device in the application form.
Yes, for the import of Medical Devices, the applicant has to obtain import license under MDR-2017 from the Central Licensing Authority. However, for Class A (non-sterile and non-measuring) medical devices, the importer has to fulfil the registration requirements to obtain the registration number.
The importer shall submit an application in Form MD-14 along with the relevant documents as prescribed in the Fourth schedule (Part I, Part II and Part III (Appendix I & II only)) and requisite fee as per Second schedule of Medical Devices Rules, 2017.
Any firm or organization who is holding valid license to manufacture the devices or holding wholesale licence or holding a registration certificate in Form MD-42 for sale or distribution under Medical Devices Rules, 2017.
An “Authorized agent” means a person including any firm or organisation who has been appointed by an overseas manufacturer through a power of attorney to undertake import of medical device in India.
Fresh import license application shall be made - in case of change in the constitution of a licensee, overseas manufacturer who executed that power of attorney and also, in case of, the change in the location of the actual manufacturer site.
In such cases, the higher risk class of Medical device may be considered by the Licensing Authority for approval of the devices in the country.
Yes.
The subsequent applicant (new agent) has to submit the documents viz. Form MD-14, Power of Attorney, Free sale certificate, requisite fees, wholesale license/ Form MD-42/ manufacturing license, Label, IFU and copy of import licence issued to earlier authorized agent along with the undertaking from the manufacturer stating that there is no change in the Device master file, Plant master file, under MDR-2017.
If the legal manufacturer, having multiple manufacturing sites for manufacturing of a specific product, that may be endorsed in the existing Import license provided a requisite documents and fee are submitted.
As per Medical Devices Rules, 2017, the timeline for grant of Import license is nine months, provided the documents are found satisfactory.
The Central Licensing Authority may carry out an inspection of the overseas manufacturing site before or after grant of the import licence as and when it is required. 
Importer can provide the India specific label, by way of stickering, when such details are not already printed on the label of the importer devices, which may include import licence number, name and address of the importer, address of the actual manufacturing premises, etc.
As per the second schedule the applicant needs to submit the applicable fee based on the risk class of the devices.
The importers need to submit Quality certificate conforming to the Quality Management System as per Fourth Schedule of MDR-2017.
An applicant shall submit Power of Attorney along with the undertaking from authorized agent as specified in the Part I of Fourth Schedule of MDR2017, duly authenticated in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by an equivalent authority through apostille, for the grant of Import license.
An applicant may apply in Form MD-20 with all requisite documents and permission can be issued by CLA in Form MD-21.
Yes. Change in Indian agent will require Fresh Import License.
If the facility is located in the Special Economic Zone (SEZ) and the firm is export oriented unit, they may export the devices after obtaining necessary permission from the competent authority. 
No. The devices can only be imported through the port notified under the Drug Rules, 1945 from time to time.
No, the importer can import the Medical Devices from any notified ports of India and stock for sale and distribution of the devices from any of their registered warehouse in the country.
Yes.
Yes, Indian authorized agent shall inform such change to CLA in writing within a period of forty-five days in the event of any change in the constitution of the overseas manufacturer or authorized agent.
Please refer to the public notice issued vide F. no. 29/Misc/03/2020-DC (124) dated 31.08.2020 issued in this regard.
No.
Investigation medical device is a medical device: 
i. which does not have its predicate device; or 
ii. which is licensed and claims for new intended use or new population or new material or major design change, and is being assessed for safety or performance or effectiveness in a clinical investigation.
No, the person or sponsor shall obtain prior permission from the Central Licensing Authority in Form MD-23 for conduct any clinical investigation in respect of Investigational medical device.
The applicant shall submit a Clinical Investigation Plan as prescribed in Table 5 of Seventh Schedule of MDR-2017.
The applicant shall submit a Clinical Investigation Report as prescribed in Table 10 of Seventh Schedule of MDR-2017.
Once an Investigational medical device is approved by the Central Licensing Authority and the product is already marketed in the country, then same can be considered as a predicate device & subsequent applicant may obtain license after complying with the requirements of MDR-2017.
No. However, if such medical device is approved by the regulatory authorities of either the UK or USA or Australia or Canada or Japan and the said device has been marketed for at least two years in that country and if the Central Licensing Authority is satisfied with the data of safety, performance and pharmacovigilance of the device, in such cases the requirement of the Clinical Investigation may be waived off which is decided on case to case basis in consultation with the Subject Expert Committee.
The applicant shall submit an application in Form MD-26 to obtain the permission in Form MD-27 under MDR-2017.
The applicant is required to submit documents as per Part IV of Fourth Schedule of Medical Devices Rules, 2017.
An application may be submitted in Form MD-18 with all requisite documents and fee as specified in Second Schedule for grant of Import license in Form MD-19 from Central Licensing Authority. 
No. However, the Ethics Committee approval needs to be obtained before initiation of the study and the data generated during the study shall not be used to furnish to the Central Licensing Authority to manufacture or to import for marketing any investigational medical device in the country.
Yes.
No, the permission for Clinical Investigation study in Form MD-23 is required for medical devices which falls under the definition of Investigational medical device.
No.
If the study is not initiated by the sponsor within a period of one year from the date of grant of permission, they need to take prior permission in Form MD-23 from the Central Licensing Authority.
The permission holder in Form MD-27 shall submit the Periodic Safety Update Report to the Central Licensing Authority from the date of launch of device in the market and such report shall be submitted every six months for first two years followed by submission of the said report annually for the two more successive years.
Yes, the Pilot Clinical Investigation data generated may be required to be submitted to the Central Licensing Authority and will be useful for designing of Pivotal study.
The Clinical investigation for Class A Investigational medical device may not be required, however, where depending on the nature of the medical device, the Central Licensing Authority, may considers such requirement.
Yes
Certain Major changes and Minor changes are prescribed in the Sixth Schedule of Medical Devices Rules, 2017. 
For major changes there may be requirement of fees as per Second Schedule of MDR-2017 however for minor changes no fee is required.
In such case, the applicant may submit an application under Post approval changes to the Licensing Authority. 
The applicant may submit the documents as per the checklist for Post approval changes provided in the CDSCO Medical Devices online portal.
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.
For any change in the version of the approved software the importer/manufacturer shall submit an application through Post Approval Change in Medical Devices Online portal.
In case of manufacturing the timeline is 45 days and for import it is 60 days.
Implementation of minor change do not need prior approval provided licensee inform CLA within a period of 30 days after the change takes place or becomes effective.
Once the application for the retention of the base license is submitted by the applicant, they may submit retention application to Licensing Authority for retention of their endorsement license issued under the base license
An acknowledgment email is received from the official email ID of the Licensing Authority. The validity of this retention will be effective from the date of expiry of the original manufacturing/import license.
In such cases, the applicant may submit subsequent endorsement application to the Licensing authority.
Yes. If the applicant has submitted their Retention application along with the requisite fee, then their license is deemed to be valid and they can market their product in the country.
The applicant may submit their retention application to the concerned Licensing Authority along with the requisite fee and the documents as per the checklist for retention available on the Medical devices online portal.
Yes.
No. If the trader/distributor is involved exclusively for stock, sale and distribution of medical device only, then they are required to obtain Registration certificate in Form MD-42.
The concerned State Licensing Authority. 
The applicant may submit an application in Form MD-41 along with requisite documents and fees as per Second Schedule of MDR-2017 through online mode in the Medical Devices online portal to concerned State Licensing Authority. 
The State Licensing Authority may issue Form MD-42 within ten days from the date the application, provided the data found satisfactory. 
Registration certificate issued by the State Licensing Authority in Form MD42 is in perpetuity, however, the registration certificate holder shall pay a registration certificate retention fee in every five years under the provisions of MDR- 2017. 
Risk parameters for classification devices used in animal are the same as per prescribed under First schedule of MDR-2017 and same risk class as mentioned in the risk classification notice is applicable.
In such case, the applicant can submit the any other relevant certificates issued by the competent authority, confirming the Quality Management System in the manufacturer premises.
Yes.
No, in such case, the firm need to obtain approval from the licensing authority through Post Approval Change
No. 
An authorised agent of the foreign manufacturer who intend to obtain the import license for import of medical device(s) which is already licensed to another agent/importer under MDR-2017, provided the legal and actual manufacturing site of the device is the same.
No. However the applicant shall submit AERB approvals to the licensing authority, prior to use of such device on Indian population. 
No. However, such raw materials/components need to qualify applicable standards and Quality Management System.
As per the existing practice, in case if such component or part which is to be imported is critical in nature which attracts the definition of medical device and affects the performance or safety characteristics or the intended purpose of the medical device, then import license is required.
Yes.
Only a Government hospital or a statutory medical institution allowed to import small quantity of investigational medical device which is approved in the country of origin, for treatment of a patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need. Application in Form MD-18 need to be submitted through Online System for Medical Devices. www.cdscomdonline.gov.in/NewMedDev/ViewDevicePersonal
No
No
No. For import/manufacture of radiopharmaceutical products, the applicant may obtain license under Drug Rules,1945 of Drug & Cosmetics Act, 1940.
Not required, however the authority may verify if there is any change in the QMS requirement.
Not required, however the authority may verify if there is any change in the laboratory QMS requirement.
Yes
No.
In such cases the applicant may follow the pathways as under: The applicant may initially obtain Test license in Form MD-13/MD-17 (for purpose of testing or clinical investigation, as the case may be) to manufacture/import test batches for generation of validation data, etc. Thereafter, apply in Form MD-26 along with the requisite fees and documents including clinical evidence data generated on the device to obtain Form MD-27 prior to apply for license to manufacture or import in relevant forms from the concerned licensing authority. In case no clinical data or inadequate data on safety and performance is generated on the device, the applicant may conduct the study after obtaining permission in Form MD-23 and submit the same for consideration of their application for marketing in the country. 
Mass produced devices, which only need adaption to meet the specific requirement of a medical practitioner or any other professional user, shall not be considered as Custom-made device. 

All provisions of Chapter IV and Chapter V of MDR-2017 are exempted, subject to the condition that the device is being specifically made in accordance with a duly qualified medical practitioner's written prescription under his responsibility, in accordance with specific design, characteristics and the same is intended for the sole use of a particular patient and the label contains the words 'Custom made device'. Only change in dimension of devices cannot be considered under custom medical devices
No.
No.
The patient or his nominee, may apply in Form MD-20 along with documents and medical prescriptions to the Central licensing authority, through Online System for Medical Devices for obtaining the permission in Form MD-21. www.cdscomdonline.gov.in/NewMedDev/ViewDevicePersonal
In cases where the model name or number added is in consonance risk class, intended use and technical characteristics as mentioned in the current device master file, the applicant need to submit Post approval change application for its addition
In such cases, the applicant may obtain post approval changes in respect of grouping from ‘System’ to ‘Family’ and addition of model name/number
The applicant needs to submit an application under Post approval changes for change in model name or model number of the licensed device.
Any changes on the device or site licensed by the licensing authority require submission of post approval change application to concerned licensing authority under the respective category through Online systems for medical devices.
No. The applicant may refer CDSCO notice vide F.No. 29/Misc/03/2020- DC(124) dated 31.08.2020.
Applicant may write to IT cell of CDSCO-HQ through CRU (cru.division@cdsco.nic.in) for making changes in registered office address/correspondence address in Online System for Medical Devices. 
Not mandatory, in such cases the license holder may submit a separate request to IT cell, CDSCO for necessary changes in the existing login credential along with relevant documents and updated credentials may be used for submitting fresh application. However, if they wish to create a separate credential for obtaining the fresh license, the existing credentials may be considered deactivated and the same need to be informed to IT cell-registration desk for necessary action to deactivate the credential.
No. The devices can only be imported through the port notified under the Drug Rules, 1945 from time to time.
Yes. The State/UT Licensing Authority can transfer the application file to another Notified body through their concerned Nodal officer to another Notified body for the conduct of QMS audit.
The communication between State/UT Licensing Authority and the Notified body can be made through e-vartalap (communication box) as provided in Online System for Medical Devices.

No FAQs found

Try different keywords or contact us for help.

Quick Links

Medical Device Regulatory Consultants

37-38, 1st Floor, Near Makhan Bhog, G.T. Road,
Kundli Industrial Area, Delhi NCR, 131028

Call Us On

+91 93064 68090

+91 93505 67270

Email Us On

executive.mdr2@gmail.com

mdrconsultants.in@gmail.com

executive.ash@gmail.com

©2025. All Rights Reserved By MDR Consultants | Powered By CREATIVEPATH