This article, Schedule Fourth of MDR 2017, provides a list of comprehensive documents required for Schedule Fourth Medical Devices Rules (MDR) 2017. It frames the essential administrative work that producers and importers should submit to get licenses for Class A, Class B, Class C, and Class D medical devices. Whether you are applying for a manufacturing license or an import permit, the category of required documents, from device descriptions and material development to quality confirmations and site ace documents. We aim to help you navigate the regulatory requirements proficiently, guaranteeing you have an understanding of what is needed to comply with the rules governing medical devices in India.

List of the Documents Required for the Schedule Fourth of MDR 2017 Include:-

1. Documents to be submitted with the application for grant of Import Licence or license to manufacture for sale or distribution of a Class A medical device:
2. The applicant shall submit documents as specified in the Table below:

S.No	For Medical Devices	In Vitro Diagnostic Medical device
1	Device Description, Intended Use, Specification Including Varietents and Accessories	Description of the Device, Specification including Variants & Accessories. Intended use of the device
2	Material of Construction	Relevant analyst and test procedure, Summary of analytical technology
3	Work principle and novel technology use	Working principle and novel technology use (if any
4	Labels, package insert (instructions for use or electronic instructions for use), user	labels and package inserts (IFU, etc.,), user manual, wherever available
5	summary of any reported Serious Adverse Event in India or in any of the countries where the device is marketed and action taken by the manufacturer and National Regulatory Authority concerned;	analytical performance summary including sensitivity and specificity;
6	site or plant master file as specified in Appendix I of this Schedule (Provided as under);	site or plant master file as specified in Appendix I of this Schedule;
7	constitution details of the firm (of the domestic manufacturer or authorized agent);	constitution details of the firm (of domestic manufacturer or authorized agent);
8	essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the medical device;	essential principles checklist for demonstrating conformity to the essential principles of safety and performance of the in vitro medical device;
9	undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule;	undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions of the Fifth Schedule;

2. In case of an application for an import license, the authorized agent shall submit
   1. Notarized Copy of documents:

Overseas manufacturing site or establishment or plant registration (or of any name given by  the country of origin) And Free Sale Certificate issued by the National Regulatory Authority or equivalent competent Authority

2. Notarised Copy of the following document issued by the competent Authority, in respect of the manufacturing site:

Quality Management System certificate Full Quality Assurance certificate or Production Quality Assurance certificate 

3. Self-attested Copy of valid wholesale license or Manufacturing license
4. Copy of latest inspection or Audit reports carried out by Notified bodies or National Regulatory Authority or Competent Authority within the last three years, if any.
5. Documents to be submitted with the application for grant of license to manufacture or import Class B, Class C or Class D medical devices:

1. Constitution details of the domestic manufacturer or authorized agent;
2. Site or plant master file as specified in Appendix I of this Schedule;
3. Device master file as specified in Appendix II for medical devices other than in vitro diagnostic medical devices or Appendix III for in vitro diagnostic medical devices of this Schedule; 
4. Essential Principles checklist for demonstrating conformity to the Essential Principles of Safety and Performance of the Medical Device, including in vitro diagnostic medical device;
5. Test license obtained for testing and generation of quality control data (for domestic manufacturers only), if any;
6. We are undertaking a sign stating that the manufacturing site complies with the provisions of the Fifth Schedule.
7. Documents as specified in clause 2 of paragraph A of this part.

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Site Master File/Plant Master File: (As per Appendix I of this Schedule)

The manufacturer shall prepare a brief document in the form of a site master file containing specific information about the production or control of device manufacturing carried out at the premises. It shall contain the following Information,-

1. General Information: 

(i) brief information on the site (including name and address), relation to other sites;

(ii) manufacturing activities; 

(iii) any other operations carried out on the site; name and exact address of the site, including telephone, fax numbers, website URL, and email address; 

(iv) name and exact address of the site, including telephone, fax numbers, website URL and e-mail address;

(v) type of medical devices handled on the site and information about specifically toxic or hazardous substances handled, mentioning the way they are handled and precautions taken; 

(vi) a short description of the site (size, location immediate environment, and other activities on the site); 

(vii) number of employees engaged in production, quality control, warehousing, and distribution; 

(viii) use of outside scientific, analytical, or other technical assistance about the design, manufacture, and testing; 

(ix) short description of the quality management system of the company; 

(x) device details registered with foreign countries; 

(xi) brief description of the testing facility; 

2. Personnel:

(i) Organization chart showing the arrangements for key personnel 

(ii) qualifications, experience, and responsibilities of key personnel; 

(iii) outline of arrangements for basic and in-service training and how records are maintained; (iv) health requirements for personnel engaged in production 

(v) personnel hygiene requirements, including clothing.

3. Premises and Facilities:

(i) layout of premises with an an indication of scale; 

(ii) nature of construction, finishes/fixtures and fittings;a  

(iii) brief description of ventilation systems. More details should be given for critical areas with potential risks of airborne contamination (including schematic drawings of the systems). Classification of the rooms used for the manufacture of sterile products should be mentioned;

(iv) particular areas for the handling of highly toxic, hazardous and sensitizing materials; 

(v) brief description of water systems (schematic drawings of the systems are desirable) including sanitation; 

(vi) maintenance (description of planned preventive maintenance programs for premises and recording system);

4. Equipment:

(i) Brief description of significant production and quality control laboratory equipment (a list of the equipment is required); 

(ii) maintenance (description of planned preventive maintenance programs and recording system); 

(iii) qualification and calibration, including the recording system. Arrangements for computerized systems validation

5. Sanitation:

Availability of written specifications and procedures for cleaning the manufacturing areas and equipment. 

6. Production: 

Brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters ; 

(ii) arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release, and storage; 

(iii) arrangements for reprocessing or rework; 

(iv) arrangements for the handling of rejected materials and products; 

(v) a brief description of general policy for process validation. 

(vi) Brief description of sterilization facility;

7. Quality Assurance:

Description of the quality assurance system and the activities of the quality assurance department. Procedures for the release of finished products

8. Storage:

Policy on the storage of medical device

9. Documentation:

Arrangements for preparing, revising, and distributing necessary documentation, including storage of master documents.

10. Medical Device Complaints and Field Safety Corrective Action:

(i) Arrangements for the handling of complaints ; 

(ii) Arrangements for the handling of field safety corrective action.

11. Internal Audit: 

Short Description of the Internal Audit System

12. Contract Activities: 

Description of how the compliance of the contract acceptor is assessed.

Device Master File 

• Executive Summary
• Device Description/Product Specification
• Label & IFU
• Device Design & Manufacturing Information
• Essential checklist
• Risk Analysis 
• Risk analysis and control summary
• Verification and validation of the medical device
• Biocompatibility
• Medicinal substances
• Biological safety
• Sterilization
• Software verification and validation
• Animal studies
• Stability data
• Clinical evidence
• Post Marketing Surveillance data

What are the Requirements for Implementation of Schedule Fourth of MDR 2017?

The requirements for implementation of Schedule fourth of MDR 2017 is mentioned below:-

• Maintain Documentation – Maintain comprehensive documentation demonstrating adherence to these standards.
• Follow all the Standards – Follow all the Indian standards listed in the Fourth Schedule of MDR 2017.
• Conducting Testing – Conduct necessary product testing, including safety and performance evaluations.
• Obtain Certification – Obtain third-party certification to verify compliance with the standards.
• Go through Audits – Undergo periodic audits and inspections conducted by regulatory authorities.
• Ensure Quality – Establish and maintain quality assurance procedures to ensure consistent adherence to the standards.

Conclusion

The  Schedule Fourth of the Medical Devices Rules (MDR) 2017 requires manufacturers and importers to submit a comprehensive set of documents to get the necessary licenses for Class A, B, C, and D medical devices in India. These documents ensure rigorous compliance with safety and performance standards and facilitate regulatory oversight.