Get Medical Devices CDSCO License, Medical Devices Import License, Medical Devices Manufacturing License in India

Services Provided by Pharmadocx For Medical Devices License

Pharmadocx Provides various service related to CDSCO Medical Devices License for Manufacturing and Import of Medical Devices of all categories. Following are the broad categories of services provided by Pharmadocx for Medical Devices.

License Application

We will help you in filing of online application for grant of license to import and manufacture medical devices of all risk classes. Our team of experts know requirements of CDSCO well you ensure the process is hassle free for you. We will also guide you with the queries which are raised on the portal and help in timely resolution to the same.

We provided online application services in all states. Licenses Pharmadocx can apply for you are MD3, MD4, MD5, MD6, MD7, MD8, MD9, MD10, MD12, MD13, MD14, MD15.

Layout Designing

Having provided layout designing consultation to over 200 pharmaceutical units and 150 medical device units. We have a vast experience in designing of manufacturing units. Our team of experts will design manufacturing units in compliance to both Medical Device Rules, 2017 and ISO 13485. Keeping in mind the current goods manufacturing practices and other state of the art practices.

Device Master Files

Device master filles or DMF are a technical document which informs the auditing body with all the relavant information to assess the conformity of the medical device to the international standards and local standards. They include history of the medical device along with all stages of design and development

Device master files are an integral part of license application for grant of License by CDSCO. Our team of experts will provide services for writing of device master files as per Schedule IV of the medical device rules, 2017. Device master files prepared by Pharmadocx Consultants will be in line to the requirements of both Medical Device Rules, 2017 and ISO 13485.

Ensuring you can apply for both license and ICMED certificate from notified body in a hassle free manner.

Content of Device master file will include

• Executive Summary

• Device Description and product specification, including variants and accessories.

• Labelling

• Design and Manufacturing Information

• Essential Principles Checklist

• Risk analysis and Control Summary

• Verification and Validation of Medical Device

This will be prepared according to the Schedule IV of the medical device rules, 2017

Plant Master File as per Medical Device Rules, 2017

Just how a device master file provides information regarding the medical device. A plant master file provides all information about the facility. This allows the auditor to assess the conformity of the facility as per Medical Device Rules, 2017 or any other international standard.

Our team can help you in preparation of quality Plant Master file to achieve manufacturing license by CDSCO. The content of Plant Master File prepared by Pharmadocx Consultant includes.

• General Information

• Personnel

• Premises and Facilities

• Equipment

• Sanitation

• Production

• Quality Assurance

• Storage

• Documentation

• Medical Device Complaints and Field Safety Corrective Action

• Internal Audit

• Contract Activities

This Plant Master file will be prepared in accordance with Schedule IV of the Medical Device Rules, 2017

Audit For Manufacturing license

Prior to grant of license to manufacture. An audit is conducted by the notified bodies or the CDSCO medical Device officers. Pharmadocx helps you in getting ready for audit by both the notified bodies and the state licensing authorities.

We help you in preparation of documents and conduct a mock audit prior to the audit by the officials to ensure no major non conformities are found during the final audit.

ISO 13485:2016 and ICMED Certificate

Certification from a notified body has become a necessity in the current market. For that we provide services for consultation for grant of ISO 13485:2016 and ICMED Certificate from NABCB bodies.

Audit is conducted prior to issuance of these certificates. We will help you in preparation of documents and conduct a mock audit prior to the audit by the officials to ensure no major non conformities are found during the final audit.

Frequently Asked Questions

What are Different Classes of Medical Devices

As per Medical Device Rules, 2017 Released by CDSCO. Medical Devices are classified on the basis of the risks associated with them. They range from low risk to very high risk medical devices. They are graded as follows

Risk Class	Description
Class A	Low risk
Class B	Low Moderate risk
Class C	Moderate High Risk
Class D	High risk

CDSCO has released various notifications regarding classification of medical devices into various categories. They can be downloaded from our website’s download’s section. The same can also be downloaded from CDSCO online portal.

Manufacture of Class A Non Sterile and Non Measuring Medical Devices.

Medical Devices Classified as class A which are not used measuring and are supplied in Non Sterile condition are known as Class A Non Sterile Non Measuring Devices. These medical devices have been exempted from provisions of Schedule IV and Schedule V of the Medical Device Rules, 2017.

Notification by which Medical Devices of Class A were exempted from the licensing regime can be downloaded using this link. Based on the notification mentioned above. Products of class A (Non Sterile Non Measuring)only need to be registered as per Chapter IIIB of the medical device rules, 2017.

Pharmadocx can help you in getting CDSCO registration for manufacture of Class A non measuring non sterile medical devices.

License for Manufacture of Class A Sterile, Measuring and Class B Medical Devices as per CDSCO

Medical devices falling under Class A or Class B require a license on form MD05 for manufacturing. This license is granted by the state licensing authority. Audit is conducted prior to grant of license by the SLA.

The audit will be conducted by auditors from a notified body. List of approved notified bodies can be viewed on our website. You can also see updated list of notified bodies of the NABCB Portal

Pharmadocx Can help you in obtaining license on form MD 5. We have provided services to over 150 companies for Medical Device Manufacturing licenses.

License for Manufacture of Class C and Class D Medical Devices as per CDSCO

To manufacture medical devices of Class C and Class D a license on form MD9 is required. This license is granted by the central licensing authority. Audit is conducted prior to grant of license by the CDSCO.

In this case audit is conducted by Medical Device Officers from CDSCO. CDSCO has been divided into various zones. Audit is conducted by a team from zonal offices. License will be issued from Head Quarters in Delhi.

Import of Class A Non Sterile and Non Measuring Medical Devices

Medical Devices Classified as class A which are not used measuring and are supplied in Non Sterile condition are known as Class A Non Sterile Non Measuring Devices. These medical devices have been exempted from provisions of Schedule IV and Schedule V of the Medical Device Rules, 2017.

Notification by which Medical Devices of Class A were exempted from the licensing regime can be downloaded using this link. Based on the notification mentioned above. Products of class A (Non Sterile Non Measuring)only need to be registered as per Chapter IIIB of the medical device rules, 2017.

Pharmadocx can help you in getting CDSCO registration for import of Class A non measuring non sterile medical devices.

Import of Class A (Sterile and Measuring), Class B, Class C, Class D Medical Devices

For import of Class A (Sterile and Measuring), Class B, Class C, Class D Medical Devices. A license on form MD15 is required from the CDSCO. The application is made on form MD14.

The license is issued by the Head Quarters in Delhi. State licensing authority plays no role in the process.

Pharmadocx can help you in getting CDSCO registration for import license on MD15

Contact us

We at Pharmadocx will be more than happy to provide consultation services for registration and licenses of all types for manufacture and import Medical Devices as per CDSCO.

Feel free to contact us at +91 9996859227 for any queries or email us as [email protected]

You can also visit our website for more information regarding medical devices.

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