Site Master File For Medical Device

Site Master File For Medical Device is a proper document that contains information related to the manufacturing plant. The site master file is the necessary document for the manufacturer of medical device. The file contains a comprehensive overview of the company’s operations and quality management systems. For the better quality management, maintaining manufacturing risk, ensuring regulatory compliance, and facilitating regulatory maintaining up to date Site master file is mandatory. We ELT Corporate Pvt Ltd will help you to know about the importance of Site Master File For Medical Device.

What Is Site Master File? 

Site master file is a mandatory document that is necessary to have. In this file all the necessary information about the manufacturing plan is mentioned. In this file the manufacturing plan information, quality, area, management and manufacturing details are mentioned.

What’s The Information Mentioned In The Site Master File For Medical Device? 

In the site master file the general information is necessary to mention. You have to write brief information related to the site, manufacturing activities, other operations need to carry on site, name & other information about the site plant. To understand about the site master file more you can connect with us on call 9891998002.

  • General Information about the plant.
  • Personnel
  • Premises & facilities
  • Equipment Using in Manufacturing Plant
  • Sanitation
  • Production Of Commodities in brief
  • Quality Assurance
  • Stoarge Policy Of Medical Devices
  • Documentation
  • Medical Device Complaints and Field Safety Corrective Action
  • Internal Audit
  • Contract Activities

What Is The Importance Of Site Master File For Medical Device? 

Site master file is a comprehensive file that contains information about the manufacturing site, its facilities, and the quality management system in place. If you are working in a medical industry then you must know about the importance of Site Master File:-

Regulatory Compliance 

The SMF is a mandatory for regulatory compliances. It contains the information about the site plant for the manufacturing company. It is a part of the regulatory submission process. It ensure that the manufacturing sites comply with the good manufacturing practices regulations.

Quality Management System Overview 

It provides detailed information related to the quality management system of the manufacturing site. The file contains the whole information of the organizational structure, responsibilities, procedures, and processes. It is related to the product and control of the pharmaceuticals medical device products registration.

Facility Information 

In this file the facility information of the manufacturing area such as physical facilities, layout, and utilities. The facility information of any company is necessary because through this regulatory agencies can find out whether the facilities meet the necessary standards for the production of safe and effective products.

Documentation of GMP Compliance 

The file stated that the manufacturing plant is working according to the Good Manufacturing Practices (GMP). Through this file GMP ensure that quality, safety, and efficacy of the products is according to the adherence.

Overview Of Product 

The file contains the information of the product that ensure that the product is safe for the consumer and what kind of raw material is utilized by the manufacturer for production.

What Is The Purpose Of A Site Master File? 

The Site Master File is a fledged information document created by the manufacturer. In this documents whole information related to the production and control manufacturing at site. It also consists the information of the closely integrated products near by the building. The purpose of the report is to specify the manufacturing of the company to the government and show that they are performing a legal activity with full protection.

How Many Pages Is A Site Master File? 

The site master file comprises 25-30 pages that contain whole information of the manufacturing plant.

What Are The Guidelines For Site Master File? 

The guidelines for the site master file are as follow. You need to go with this before creating a site master file for medical devices:-

  • The file must carry adequate information as far as possible.
  • Site Master File must consist only 25-30 pages including appendices.
  • The file contains simple plans, outlines drawings, & layouts according to the guidelines.
  • The files must be easy to read when printed on the A4 paper sheets.
  • It comprises all information regarding the manufacturing site, product quality & safety & more.

Also Know About – How To Get Test License For Medical Devices?

Is a Site Master File Required? 

Yes, Site Master File For Medical Devices is a necessary document prepared by the manufacturers about the manufacturing site. With this, a manufacturer is not allowed to get approval for manufacturing products.


The Full Form OF SMF is Site Master File and it is a mandatory file prepared by the manufacturer. The SMF file contains whole information regarding the manufacturing plant. Through this, the government can simply figure out the detail about the product quality & safety.