DEVICE MASTER FILE as per Indian Medical device Rules 2017
- 1. DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES • Device Master File means detailed information concerning the product which is to be submitted to relevant regulatory authority in accordance with the requirements of Fourth Schedule of IMDR 2017. • Medical Devices are article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. • Medical Device regulations in India are administered by the Central Drugs Standard Control Organization (CDSCO). • In India, there were no specific medical device regulations and devices were regulated under the Drugs and Cosmetics Act, 1940. To fulfill this gap, Central Drug Standard Control Organization released Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India. • Keeping pace with the requirements, these were amended as Medical Devices (Amendment) Rules, 2020, which has come into force in April 2020.
- 2. Classification of medical devices for other than in vitro diagnostic medical devices: (i) low risk - Class A; (ii) low moderate risk- Class B; (iii) moderate high risk- Class C; (iv) high risk- Class D. The Central Licensing Authority shall be the competent authority for enforcement of rules in matters relating to manufacture of Class C and Class D medical devices, while for Class A and Class B medical devices, the competent authority shall be State Licensing Authority. • Any Notified Body with an experience of at least two years, may apply to the Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical devices, provided it has personnel with requisite qualification and experience. • The Notified Body accredited may make an application to the Central Licensing Authority for registration in Form MD-1 through online portal accompanied with a fee along with documents. • The Central Licensing Authority, on being satisfied, shall register the Notified Body and issue a registration certificate in Form MD-2. • The Registration Certificate shall remain valid in perpetuity, unless, it is suspended or cancelled, provided the registration certificate holder deposits a registration retention fee every five years from the date of its issue.
- 3. • If the registration certificate holder fails to pay the required registration certificate retention fee on or before due date, the registration certificate holder shall, in addition to the retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part thereof within ninety days, and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been cancelled.
- 5. 1. Executive Summary An Executive Summary shall be provided by the manufacturer and mainly contain: 1.1 Introductory descriptive information on the medical device 1.2 Information regarding sterilization of the device 1.3 Risk Management Plan 1.4 Clinical Evidence and evaluation (if applicable) 1.5 Regulatory status of the similar device in India 1.6 Design Examination Certificate, Declaration of Conformity 1.7 Marketing history of the device 1.8 Domestic price of the device 1.9 List of regulatory approvals or marketing clearance obtained 1.10 Safety and performance related information (a) Summary of reportable event and Field safety corrective action (b) If the device contains any of the followings, then descriptive information on the following need to be provided.
- 6. 2. Device description and product specification, including variants and accessories 2.1 The dossier should contain descriptive information for the device:- (a) A general description (b) the medical condition to be diagnosed or treated; (c) mode of action; (d) an explanation of any novel features; (e) a description of the accessories; (f) a complete list of the various configurations or variants of the device; (g) a general description of the key functional elements, e.g. its formulation, its composition, its functionality; (h) a description of the materials incorporated into key functional elements: (i) for medical devices intended to emit ionizing radiation, information on radiation source (e.g. radioisotopes). 2.2 Product Specification 2.3 Reference to predicate or previous generations of the device 3. Labelling Information on labelling should include the following:- (a) Copy of original label of the device, including accessories if any, and its packaging configuration; (b) Instructions for use (Prescriber’s manual); (c) Product brochure; and (d) Promotional material.
- 7. 4. Design and Manufacturing Information 4.1 Device Design 4.2 Manufacturing Processes 5. Essential Principles Checklist (i) The dossier should contain the following:- the essential principle applies; the method used to demonstrate conformity with each essential principle and its reference; the precise identity of the controlled document that offers evidence of conformity with each method used. (ii) Methods used to demonstrate conformity may include one or more of the following: (a) conformity with standards as referred to in rule 7; (b) conformity with an in-house test method; (c) the evaluation of pre-clinical and clinical evidence; (d) comparison to a similar device already available on the market. (iii) A cross-reference to the location of such evidence 6. Risk analysis and control summary: Risks identified during the risk analysis process and how these risks have been controlled to an acceptable level.
- 8. 7. Verification and validation of the medical device 7.1 General: (A) The dossier should contain product verification and validation documentation. It should summarize the results of verification and validation studies (B) Summary information may include: (i) declaration or certificate of conformity to a recognised standard and summary of the data if no acceptance criteria are specified in the standard; (ii) declaration or certificate of conformity to a published standard that has not been recognised; (iii) declaration or certificate of conformity to a industry method, or in-house test method; (iv) a review of published literature regarding the device or substantially similar devices. (C) Also, the dossier should contain detailed information on: (a) biocompatibility studies data; (b) medicinal substances incorporated into the device; (c) biological safety of devices incorporating animal or human cells, tissues or their derivatives; (d) sterilisation; (e) software verification and validation; (f) animal studies that provide direct evidence of safety and performance of the device; (g) clinical evidence. (D) Detailed information will describe test design
- 9. 7.2 Biocompatibility: (i) The dossier should contain a list of all materials. (ii) To characterize the physical, chemical, toxicological and biological response of a material. At a minimum, tests should be conducted on samples from the finished, sterilized (when supplied sterile) device. (iii) Recording local, general and systemic adverse reactions, risks or potential risks (iv) IS0-10993, Biological Evaluation of Medical Devices. 7.3 Medicinal substances: The dossier should provide detailed information of the medicinal substance in the medical device. 7.4 Biological safety: (i) The dossier should contain a list of all materials of animal or human origin used in the device. Transmissible Spongiform Encephalopathies (TSE) or Bovine Spongiform Encephalopathy (BSE) Certificates should also be submitted. (ii) Record-keeping of sources and finished device. 7.5 Sterilization: (i) Detailed information of initial sterilization validation including sterilizer qualification. (ii) Evidence of the ongoing revalidation of the process should also be provided.
- 10. 7.6 Software verification and validation: The dossier should contain information on the software design and development process and evidence of the validation of the software, as used in the finished device. 7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide evidence of conformity. (ii) The study objectives, methodology, results, analysis and conclusions. 7.8 Stability data: If available, 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. 7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstrates conformity of the device with the Essential Principles that apply to it. It needs to address the elements contained in the Clinical Investigation, as specified under the Seventh Schedule. 7.10 Post Marketing Surveillance data (Vigilance reporting): The dossier should contain the Post Marketing Surveillance or Vigilance Reporting procedures and data collected by the manufacturer encompassing the details of the complaints received and corrective and Preventive actions taken for the same.