As per the Gazette Notifications GSR 102 (Dated 11 Feb 2020), a list of 37 medical devices specified in the Annexure of Eighth Schedule of MDR 2017 falls under the category of Regulated Medical Devices, which are as follows:

For The Above Mentioned 37 Regulated Medical Devices, A Manufacturer Makes:

• an application for grant of license or loan license to manufacture for sale or for distribution of medical device in Form-MD-3/ MD-4/ MD-7/ MD-8/ MD-12 (as per the individual case)

• a fee, as specified in the second schedule of MDR 2017

• respective documents

• an undertaking to the effect that the requirements of QMS have been complied with.

What documents are required for Registration of Regulated Medical Devices?

• ISO 13485

• Plant Master File

• Quality Management System (QMS)

  • Quality Manual

  • Quality Policy

  • Control of Documents

  • Control of Records

  • Management Responsibility

  • Internal Audit System

  • Prevention and Corrective Action

  • Human Resource

  • Environmental Requirements

• Device Master File

• Performance Evaluation Report of IVDs only

• .Obtained test license for testing and producing quality control data

What Steps involved for Medical Device Registration?

1. Step 1: Classification of Medical Devices: Medical devices shall be classified on the basis of parameters specified in the First Schedule of MDR 2017, in the following classes, namely:—

   1. low risk - Class A;

   2. low moderate risk- Class B;

   3. moderate high risk- Class C;

   4. high risk-Class 

1. Step 2: Grouping of the Medical Devices: An Applicant grouping medical devices having the same or similar intended uses or commonality of technology and submitted in a single application.

   1. Single: A medical device sold as a specific packaged unit and does not meet the criteria for a family, IVD test kit, system, IVD cluster, or a cluster. It can be sold in several package sizes. 
   2. Family: A medical device family is a collection of medical instruments and each medical device is, (i) from the same license holder; (ii) belongs to the same risk classification class; (iii) has a common intended use; (iv) have the same design and manufacturing process (v) have variations within the scope of permissible forms.
   3. Systems: Medical devices include systems, which are (i) from the same license holder; (ii) intended to be used in combination to fulfill a common intended purpose; (iii) compatible when used as a system; and (iv) sold under the name Sole Proprietorship System.
   4. Group: A medical device conglomerate is a collection of two or more medical devices, supplied in a package by the same license holder, which, (i) are sold under the name Sole Proprietorship Group; and (ii) have a common intended purpose. 

2. Step 3: Selecting Form for Medical Device Registration: To Manufacture for sale or for distribution of Medical devices or In-Vitro Medical devices, an applicant shall submit the application using:

   1. Form MD3: for Class A and Class B

   2. Form MD4: for Loan License of Class A and Class B

   3. Form MD7: for Class C and Class D

   4. Form MD8: for Loan License of Class C and Class D

   5. Form MD12: for Clinical Investigation/ test/ evaluation/ examination/ demonstration or training.

3. Step 4: Fees for Medical Device Registration: In a life cycle of a particular medical device, the stages are as below: diagram

   1. Test License: Test license to manufacture for clinical investigations, tests, evaluations, examination, demonstration, or training for each distinct medical device. (Govt. Fees 500 Rupees)

   2. Fresh License: Manufacturing license or loan license to manufacture Class A or Class B medical devices for,-

      (a) one site; and (Govt. Fees 5,000 Rupees)
      (b) each distinct medical device. (Govt. Fees 500 Rupees)

      Manufacturing license or loan license for manufacture of Class C or Class D medical devices,-

       

      (a) one site; and (Govt. Fees 50,000 rupees)

      (b) each distinct medical device. (Govt. Fees 1,000 rupees)

   3. Renew License: After every 5 years, the Manufacturing license or loan license retention fee for,-

      (a) one site manufacturing Class A or Class B Medical devices; or

      (b) one site of manufacturing Class C or Class D Medical devices; or

      (c) each distinct medical device of Class A or Class B; or (d) each distinct Medical Device of Class C or Class D.

4. Step 5: Submitting Documents: Along with the application and the fees (as specified in steps 3 and 4), an applicant shall upload on the medical device registration online portal of CDSCO, the elaborate documentation explaining the manufacturing site, the medical device, and the quality management system. For more information on the same, please click here.

5. Step 6: Inspection and Grant of License:

   1. For Class A Medical Devices: The State Licensing Authority, after examination of all documents and being satisfied that the requirements of these Rules have been complied with, may grant a license or loan license to manufacture Class A medical devices in Form MD-5. Will do Form MD-6, as the case may be, or if not satisfied, for reasons to be recorded in writing, within forty-five days from the date of rejection of the application, the application is made under sub-rule.

   2. For Class B Medical Device: The State Licensing Authority shall, after scrutiny of documents, audit report and on being satisfied that the requirements of these rules have been complied with, grant a license to manufacture Class B medical devices in Form MD-5 or loan license in Form MD-6, as the case may be, or if not satisfied, reject the application for reasons to be recorded in writing, within a period of twenty days from the date of receipt of the report of an audit by the Notified Body.

   3. For Class C and Class D Medical Devices: The Central Licensing Authority may, wherever necessary, in the case of Class C or Class D medical devices, utilize the services of an expert in the relevant field for examination of the application and other technical documents, which should be completed by the Central Licensing Authority within a period of forty-five days from the date of submission of the online application.
      In case, the documents are found to be complete and in order, the Central Licensing Authority shall inspect the construction site by a team of officers with such experts as may be considered necessary. The Central Licensing Authority may, as required, avail the services of a notified body for carrying out site inspection of Class C and Class D medical devices.
      If the Central Licensing Authority, after receiving a report that the requirements of these rules have been complied with, the authority shall grant a license in Form MD-9, or grant a loan license in Form MD-10, or may reject the application for reasons shall be recorded in writing within a period of forty-five days from the date of receipt of the inspection report.

ELT Corporate and Medical Device Registration:

ELT is renowned for its services in all areas of scientific licensing from Corporate Legal Metrology, BIS, Drugs and Cosmetics, Medical Devices, Food Safety, and Environmental Protection to New Technology Patents. ELT Corporate has a team of Advocates, Engineers, M.Pharma, Chartered Accountants, and Company Secretaries. With such a unique combination of talent under one roof, it has always been a hassle-free wonderful experience for large corporates.

ELT Corporate is one of the best Medical Device Consultants in India and has always endeavored to provide the best experience to its clients.

How we can help you with Medical Device Registration?

• We help our customers develop all documentation, whether it's a device master file, a quality manual, or management accountability.

• We help our clients to maintain various records which are mandatory as per MDR 2017.
• We also provide expert services in developing quality assurance laboratories.
• We help our clients to communicate with government portals and ministries to get licenses.

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  In a nutshell, we provide our clients with a wide range of medical equipment in India.

Blogs & Related Articles:

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• Grouping of Medical Devices as per MDR 2017

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• How to make Quality Manual?

• Essential Principles checklist for Medical Device.

• Environmental Requirements for Medical device manufacturing.