This guidance is applicable to manufacturers placed within India.
Regulation Medical Devices Rules, 2017
|License to manufacturer Notified Medical Devices||License in Form MD-5 or 6 for Class A or Class B||Application form|
Form MD-3 or 4 for Class A or Class B
|Rule 20(4) and 20(6) for Class A or Class B||State Drug Licensing Authority|
|License to manufacturer Notified Medical Devices||License in Form MD-9 or 10 for Class C or Class D||Application form|
Form MD-7 or 8 for Class C or Class D
Rule 25(1) for Class C or Class D
|Central Licensing Authority|
Determine Product Classification as per India Medical Devices Rules, 2017 if they fall under the below as per Part I of first Schedule
- Class A, B, C, D
Determine if the classified device falls under Notified Medical Devices or Non-Notified Medical Devices.
Quality Management System Certification
Establish and obtain a QMS certificate from a Notified Body (QMS defined in Fifth Schedule).
Perform Medical Device compliance testing as per BIS Standards. If no relevant BIS standard(s) are available, the manufacturer must choose to follow ISO/IEC standard compliance relevant to the medical devices
e-SUGAM Online Submission Requirements
The next significant step is to prepare the documents for the online submission as per Fourth Schedule Part I, II & III. The applicable documents are dependent on the class of device in the application.
- Name and address of the company along with the address details of the site of manufacturing
- Details of medical device:
|Generic Name||Model No.||Intended Use||Class of medical device||Material of construction||Dimension||Shelf life||Sterile or Non-Sterile||Brand name if registered under the Trademarks act, 1999|
- ISO 13485 Certificate
- Free Sale certificate from the country of Origin (not applicable for those manufactured within India)
- Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic
Other required documents are listed at the end of this article
Online Registration Process
Steps to Start CDSCO License Application Process
It is required to appoint a competent technical staff who meets the competency listed in Rule 22(ii).
- Go to CDSCO home site >> Online System for medical devices
- Click on Login/Register to arrive at the Registration homepage
- Select from the Purpose >> For Manufacture of Medical Devices
- Fill in the complete online application form
- Upload all the documents as per in the checklist
- Make the payment in the same portal (Link to Fee details are given at the end of this article)
- Once the application is filled and complete, Click Submit
- A confirmation email will be received to the registered email address
- Track the application in the online portal
Timelines for Granting CDSCO Manufacturing License
For Class A
Within 45 days from the date of receipt of application the State Licensing Authority grants the license in Form MD-5 or Form MD-6 or rejects the application
For Class B
Within 90 days from the date of receipt of the application, the Notified body shall conduct an inspection of the manufacturing site
Within 30 days, the Notified body shall submit the audit report to the licensing authority
Within 20 days, the SLA scrutinises the documents, audit report and grant License in Form MD-5 or MD-6
For Class C or D
Within 45 days from the date of receipt of application, the CLA shall perform scrutiny of the application and technical documents using an expert
Within 60 days, a site inspection is carried out by the licensing authority comprising of experts (as mentioned in Rule 23) & the inspection report is sent copy to the applicant.
Within 45 days, the CLA scrutinises the documents, audit report and grant License in Form MD-9 or MD-10
Other Documents required for submission
- Power of Attorney (provided in MDR -Fourth Schedule, Part 1) To be authenticated in India either by a Magistrate of First Class or by the Indian Embassy in the country of origin or by an equivalent authority through apostille.
- Device description intended use of the device, specification including variants and accessories.
- Material of construction.
- Working principle and use of a novel technology (if any).
- Labels, package inserts (IFU, etc.,), user manual, wherever applicable
- Summary of any reported Serious Adverse Event in India or in any of the countries
- Site or plant master file as specified in Part III Appendix I of MDR
- Device Master File Part III Appendix II (Risk assessment
- Constitution details of the firm (of the domestic manufacturer or authorised agent)
- Essential principles checklist
- Undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule
- Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years, if any.
- ISO 13485 Certificate
- Full Quality Assurance Certificate
- TR6 Challan (Service tax)
- Schedule D (1) (Drugs and Cosmetics Act)
- CE Design Certificate
- Free Sale certificate
- Other Regulatory Approvals
- PMS report
Useful Links in the CDSCO portal
Checklist for Form MD-3, Form MD-7
Fees Payment Details
https://cdscomdonline.gov.in/NewMedDev/Homepage >> Scroll down to click on “Fee Payable” icon
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Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
what about class C certificate for import only as Medical device is manufactured at south korea