Explain- Medical Device Master File, Site Master File, Quality Management System As documents

Class A and Class B devices must undergo rigorous processes that must be completed according to the guidelines and rules set by the Central Drug Standard Control Organisation (CDSCO). Furthermore, those who plan to manufacture medical devices of Class A and Class B must undergo a process through the application process for a permit to market and distribute medical equipment. The CDSCO assures the quality and safety of medical devices that are sold on the market by this method.

These applicants need to submit an application for approval to the State Licensing Authority for approval through the Department of Health and Family Welfare's web portal, based on the location of the applicant. A request must be made in FORM MD-3 along with the necessary documents required to get the license in FORM MD-5.

Important Documents To Manufacture Class A Class B Medical Devices –

The mandatory documents for filling the application stated by the CDSCO include:

• Quality Management System Documents

• Site Master File

• Device Master File

Quality Management System of Medical Devices (ISO 13485) To Manufacture Medical Device Class A / B

In simple terms the definition of a medical device's QMS (QMS) can be described as a well-organized procedure and process that cover every aspect of manufacturing, design suppliers and managing risk, handling complaints storage of clinical information distribution, product labelling, and much more. The majority of medical devices will require some kind of QMS. The level of degree of complexity of the QMS can differ based on the class that the product is classified in. For instance, companies that make low to moderate-risk (Class B) or moderate to high-risk or high-risk (Class C-D) devices will require the use of a different QMS as opposed to companies that make low-risk non-sterile, non-measuring, and surgical instrumentation that is not reusable (Class A). We will not go into the details of classification or registration in this article however, you'll need to know the classifications of your medical devices prior to creating a QMS.

In highly-regulated fields like pharmaceutical and life sciences industries, specific QMS (QMS) deals with the complicated development process for biotech, pharmaceutical, and medical devices. Medical device Quality Management Systems (QMS) is designed to help facilitate compliance with the regulations adopted through the FDA and other standards such as ISO 13485. In addition, with a medical QMS, companies in life sciences can reduce the use of paper-based quality systems enhance product quality and safety, cut overall expenses, improve operational efficiency, and integrate processes, documentation, and communications.

To be eligible to be included within the Medical Quality Management Systems (QMS) category A product must:

• Create a traceability feature for products

• Document and track every procedure and event that occurs throughout the lifecycle of the product.

• Track industry regulations and create reminders or triggers for possible violations.

• Record customer complaints to evaluate and manage the risk

• Facilitate inspections and testing of products

• Offer support and workflows for corrections to products tested

Site Master File or Plant Master File For Class A B Medical Device Manufacturing –

The manufacturer should make a brief document in the format of a Site Master File / Plant Master File containing specific information about the production and/or monitoring of the device manufacturing process that is performed at the site. A Plant Master File should include the following details:

1. GENERAL INFORMATION

• A brief description of the site (including the address and name) in relation to other websites

• Manufacturing activities

• Other activities that may be performed on the site

• Name and address of the website, including phone, fax numbers, web URL, and E-mail address

• The type of medical device handled on the website and details concerning specific toxic or dangerous substances handled, including how they are handled and the measures used

• A brief description of the site (area of the site, its location, and the immediate environment, as well as other activities at the site)

• The number of employees who are involved in Quality Control Warehousing, Production, and distribution

• Utilization of external analytical, scientific or technical assistance to the design, production, and testing

• A brief review of the quality control system employed by the business

• Devices information associated with other countries

1. PERSONNEL

• Organization chart illustrating the arrangement for important personnel

• Experience, qualifications, and responsibilities of personnel with the most important qualifications

• Outline basic and in-service instruction and how records are kept

• Health and safety requirements for workers in the production process

• The requirements for the hygiene of personnel, which includes clothing

1. PREMISES AND FACILITIES

• Layout of premises and indication of the scale

• The nature of construction, the finishings/fixtures, and fittings

• An overview of ventilation equipment. Additional details are required for areas that are considered to be critical and have potential dangers from airborne contaminants (including sketches of the ventilation systems). Rooms that are used to manufacture sterilized products are required.

• Special areas are designated for the handling of sensitive, toxic, and hazardous substances

• A brief description of water systems (schematic drawings of the system are highly recommended) including sanitation

• Maintenance (description of maintenance plans and preventive programs for buildings as well as recording systems)

1. EQUIPMENT

• Brief description of the most important manufacturing and quality control laboratory equipment (a listing of the equipment required)

• Maintenance (description of maintenance plans that are preventive programs as well as a recording method).

• Qualification and calibration of record system. Computerized system validation arrangements.

1. SANITATION

The availability of written specifications and cleaning procedures for manufacturing equipment and areas.

1. PRODUCTION

• A brief description of the production processes with, where feasible diagrams and flow sheets with crucial parameters

• The handling arrangements for beginning materials packaging materials and bulk products, which include releases, samples, quarantine, and storage.

• Reprocessing and rework arrangements

• Methods of handling materials and products that are rejected

• Short description of the general process validation policy

1. QUALITY CONTROLS

A description of the Quality Control system and of the work that are carried out by the Quality Control Department. Methods to release completed products

1. STORAGE

Storage policy for medical devices

1. DOCUMENTATION

The arrangements to prepare, revise, and distribution of the necessary documents, as well as the storage and distribution of documents master

1. MEDICAL DEVICE COMPLAINTS AND FIELD SAFETY CORRECTIVE ACTION

• Procedures for handling complaints

• Procedures for handling the corrective action in field safety

1. SELF INSPECTION

A brief description of the internal Audit System

1. CONTRACT ACTIVITIES

A description of the manner that the conformity of the contract's acceptor is evaluated

Device Master File To Manufacture Class A – Class B Medical Device Manufacturing –

The manufacturer must create a concise document in the format of a Device Master File containing specific details about the device(s) produced on the premises.

1. EXECUTIVE SUMMARY:

An executive summary should be supplied by the manufacturer and must include:

• Introductory information and description of the medical device, or In-vitro Diagnostics

• The intended purpose and the reason for use

• Class of Device,

• Unique characteristics on the devices (if there are any),

• The Shelf-Life of the medical device,

• An overview of the contents of the dossier. Information on sterilization of the device (whether the device is sterilized or non-sterile If sterile, the method of sterilization)

1. DEVICE DESCRIPTION AND PRODUCT SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES

• Device Description

• Product Specification

• Reference to predicate and/or previous versions or generations of medical device

1. LABELLING

1. DESIGN AND MANUFACTURING INFORMATION

• Device Design

• Manufacturing Processes

1. ESSENTIAL PRINCIPLES (EP) CHECKLIST

1. RISK ANALYSIS AND CONTROL SUMMARY

1. PRODUCT VERIFICATION AND VALIDATION

• Biocompatibility

• Medicinal Substances

• Biological Safety

• Sterilisation

• Software Verification and Validation

• Animal Studies

• Shelf Life/Stability Data

• Clinical Evidence

• Post Marketing Surveillance Data (Vigilance Reporting)

1. Additionally Required Information in case of the In-vitro Diagnostic kits

Product dossier consists of the following:

1. The information about the source antibody or antigen as is the situation, and characterisation of the same. Control of coating of antibody or antigen on the base materials like strips of Nitrocellulose paper or cards, or ELISA wells, and so on.

A detailed description of the kit and the manufacturing flow chart of the kit show the exact flow diagram of the individual components or sources of each component.

1. The test protocol for the kit, describing the specifications, and the method of testing.
2. Evaluation report in-house of the sensitivity, specificity, and stability tests.
3. The complete test report on every component that was used or packed inside the kit.
4. Size of the pack and labelling.
5. Inserts to the product.

Specific evaluation report, should be performed by any laboratory located in India that demonstrates the specificity and sensitivity of the test kit.

Particular processing such as material control, safe handling area Control, Process Control as well as stability tests, as well as storage at the stage of quarantine as well as at the stage of finished packaging should be noted in the dossier of the product.

Being an authorized agent for regulatory services in India since the past 10 years, CliniExperts has deep understanding of the Indian regulatory guidelines. Food Regulatory services Cosmetic Registration Drug Regulatory Services Medical Devices