Medical Devices Regulatory services

Medical Devices Regulatory Services

Medical Devices have always been an object of concern and regulation by the Indian Government. With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect. Medical devices have been categorized into A, B, C and D classes and are governed by respective central and state regulatory authorities. Regulatory bodies classify medical devices based upon the associated risk and have defined relatively easy procedures for license applications. Similarly, rules and guidelines have been promulgated by the government for the import of medical devices. Whereby, all one needs is to have an authorized Indian agent to apply for the license.

With the reformative intervention and efforts of the government such as the SUGAM portal, obtaining medical device licenses is now an expedite procedure. We at CliniExperts strive to provide our clients assistance with application and licensing procedures related to Medical Devices.

Medical Device Registration for Manufacturers & Importers

New Device – First time in India

As per government rules, a medical device which itself or its predicate hasn’t yet been included in the medical devices list of CDSCO (Central Drugs Standard Control Organization) is considered a new medical device. Moreover, already registered devices vying to apply for new claims with respect to different implementation factors will also be treated as new devices.

New Device Registration for Manufacturers & Importers

Classification of Medical Devices in India

Following the latest reforms, medical devices have been classified into 4 major categories based upon their usage risk and further classified into surgical and non-surgical equipment.

Risk Based Classification

Class A Low

Class b Low-Moderate

Class c Moderate-High

Class D High

Medical devices have been classified into A, B, C and D categories where the risk factor involved increases from A to D. Low-risk devices include equipment like thermometers whereas high-risk devices include pacemakers, heart valves and others. The devices are further classifed as surgical or non-surgical devices based upon their invasiveness. License for class A devices is easy to obtain as compared to class D devices.

Overview of forms for application

The Central Drugs Standard Control Organization has formulated a set of forms to receive application for medical device licenses. These forms differ based upon the intended purpose of application. Different forms have been classified for importers and manufacturers, further diversifying them upon the basis of risk factor associated with different medical devices. Applying for individual medical devices is easy whereas application for multiple devices for import or manufacturing requires a great deal of attention.

Existing Devices

Applicant Risk/Class Type of Licence Forms
Importer A, B, C, D Importer License Application: MD-14
Permission: MD- 15
Manufacturer A, B Manufacturing License Application: MD-3
Permission: MD- 5
Loan License Application: MD-4
Permission: MD- 6
C, D Manufacturing License Application: MD-7
Permission: MD- 9
Loan License Application: MD-8
Permission: MD- 10

New Devices

Applicant Risk/Class Type of Licence Forms
Importer A, B, C & D Clinical Investigation
Permission
Application: MD-22
Permission: MD- 23
A, B, C & D Import License Application: MD-26
Permission: MD- 27
A, B, C & D Test License Application: MD-16
Permission: MD- 17
Manufacturer A, B, C & D Clinical Investigation
Permission
Application: MD-22
Permission: MD- 23
A, B, C & D Manufacturing License Application: MD-26
Permission: MD- 27
A, B, C & D Test License Application: MD-16
Permission: MD- 17

For Importers

With the recognition of India as a prominent global market and fast growing economy, international companies are now vying to grab a share of the Indian medical device market. In this wake, the Indian government has revised its respective laws and regulations to create a more friendly environment for medical imports. Authorities have promulgated rules to include and classify new medical devices in-line with the growing global trends and technology.

The process for granting licenses has been simplified and paced to allow quick launch of products in the market. The documentation and procedures have been aligned with global formats and conventions to unify and simplify procedures.

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Import License Process

Classification of Medical Device
Classification
of Medical Devices

Authorized Agent / Registration Holder Support
Authorized Agent /
Registration Holder
Support

Application Filing
Aplication Filing
(Form MD- 14)

Import License
Import Licence
(Form MD- 15)

Authorized Agent / Registration Holder

Indian regulations require a foreign company to seek the help and support of an authorized licensing agent. Regulations restrict foreign manufacturers to apply for a medical device license directly to CDSCO. The foreign manufacturer must appoint an authorized representative which may be an individual or a firm through the power of attorney to file an application on the manufacturer’s behalf.

An authorized agent must hold a valid wholesale license to undertake the import procedure. CliniExperts holds a valid import license (Form 20B and 21B) to assist foreign manufacturers to import their medical devices in India in less time and without any hassle. Hence speeding up their business ventures.

Permission for Import License (Form MD-14, Form MD-15)

Indian regulations require a foreign company to seek the help and support of an authorized licensing agent. Regulations restrict foreign manufacturers to apply for a medical device license directly to CDSCO. The foreign manufacturer must appoint an authorized representative which may be an individual or a firm through the power of attorney to file an application on the manufacturer’s behalf.

An authorized agent must hold a valid wholesale license to undertake the import procedure. CliniExperts holds a valid import license (Form 20B and 21B) to assist foreign manufacturers to import their medical devices in India in less time and without any hassle. Hence speeding up their business ventures.

Permission for test license to import Medical Device (Form MD-16, Form MD-17)

Indian regulations require a foreign company to seek the help and support of an authorized licensing agent. Regulations restrict foreign manufacturers to apply for a medical device license directly to CDSCO. The foreign manufacturer must appoint an authorized representative which may be an individual or a firm through the power of attorney to file an application on the manufacturer’s behalf.

An authorized agent must hold a valid wholesale license to undertake the import procedure. CliniExperts holds a valid import license (Form 20B and 21B) to assist foreign manufacturers to import their medical devices in India in less time and without any hassle. Hence speeding up their business ventures.

For Manufacturer

New rules and regulations have been promulgated by the authorities for manufacturing medical devices in India. The licensing authorities for filing applications vary based upon the classification of medical devices. Manufacturers aiming to manufacture Class A and Class B medical devices will be entertained and granted licenses by the State Licensing Authority. Whereas applications of manufacturers vying for Class C and Class D medical devices will be reviewed and granted permission by the Central Licensing Authority. CDSCO has also predefined appropriate application fees for different medical devices.

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Manufacturing License for Medical Devices from SLA/CLAA

Manufacturing License for Medical Devices from SLA/CLAA

Permission to Manufacture or Permission for loan license to manufacture Class A & B Medical Device in India from State FDA (Form MD-5 and Form MD-6)

Licensing of Class A (Low risk) and Class B(Low to Moderate Risk) devices falls under the jurisdiction of State Licensing Authorities. CliniExperts has a vast network of offices and associates in all Indian states to help the manufacturer in filing an application with the respective state FDA authority. Our team will help you in obtaining, filling and the submission of appropriate forms for obtaining manufacturing or loan license permission.

Permission to Manufacture or Permission for loan license to manufacture Class C & D Medical Device in India from CDSCO (Form MD-9, Form MD-10)

Licensing of Class A (Low risk) and Class B(Low to Moderate Risk) devices falls under the jurisdiction of State Licensing Authorities. CliniExperts has a vast network of offices and associates in all Indian states to help the manufacturer in filing an application with the respective state FDA authority. Our team will help you in obtaining, filling and the submission of appropriate forms for obtaining manufacturing or loan license permission.

Permission for test license to manufacture Medical Device(Form MD-12, Form MD-13)

Licensing of Class A (Low risk) and Class B(Low to Moderate Risk) devices falls under the jurisdiction of State Licensing Authorities. CliniExperts has a vast network of offices and associates in all Indian states to help the manufacturer in filing an application with the respective state FDA authority. Our team will help you in obtaining, filling and the submission of appropriate forms for obtaining manufacturing or loan license permission.

Investigational New Device/ New Device –
First Time in India

Process for New Medical Devices – First time in India

A new medical device whose similar or predicate is not available in India, or any other existing medical device with a change in design or intended use, needs to demonstrate their safety before applying for the license. In this accord, a clinical investigation has to be conducted on human participants to evaluate the effectiveness and safety of the medical device. Once the clinical investigation has been completed and the device is regarded safe, an application for the import or manufacture of this new investigational medical device can be filed with the Central Licensing Authority (CLA).

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Process for New Medical Devices - First time in India

Clinical Investigation

Clinical Investigation is required to be conducted in human participants in India for the
following conditions:

Class A & Class B

medical devices do not require a clinical investigation hence the application for their import or manufacturing can be filed directly.

Class C & Class D

medical devices which have not been granted a free sale certificate by any of the GHTF countries (U.S, Canada, EU, Japan and Australia) inevitably require a clinical investigation to be conducted.

Permission to conduct Clinical Investigation for Investigational Medical Device (MD-23)

Clinical investigation is mandatory to be conducted for Class C and Class D devices. However, an applicant can file an application to conduct clinical investigation on devices of any class. An application for the clinical investigation of a medical device has to be filed at the Central Licensing Authority(CLA). We at CliniExperts help our clients in filing the applications and obtaining a clinical investigation license. Our dedicated and experienced experts ensure that the license obtaining process is hassle free and quick.

Permission to import/manufacture medical device which does not have a predicate device (Form MD-27)

Licensing of Class A (Low risk) and Class B(Low to Moderate Risk) devices falls under the jurisdiction of State Licensing Authorities. CliniExperts has a vast network of offices and associates in all Indian states to help the manufacturer in filing an application with the respective state FDA authority. Our team will help you in obtaining, filling and the submission of appropriate forms for obtaining manufacturing or loan license permission.

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