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Regulatory Services for Medical Devices

The Indian government has consistently regulated and monitored medical devices due to their critical nature. With the continuous evolution of medical technology and the escalating demand for such devices in the country, new regulations and reforms have been implemented. These devices are now classified into categories A, B, C, and D, each overseen by relevant central and state regulatory authorities. Classification is based on the associated risk, and streamlined procedures for license applications have been established. The government has also instituted rules and guidelines for the import of medical devices, requiring the involvement of an authorized Indian agent for license applications.

Thanks to the government's proactive measures, like the SUGAM portal, acquiring licenses for medical devices has become a more efficient process. At ZYPS, we are dedicated to offering regulatory services for medical devices, providing support to our clients in navigating through application and licensing procedures.

Step by Step: Registration Process of Medical Devices in India

India belongs to one of the top 20 medical device markets in the world. As per various reports, the medical device market in India is expected to reach a valuation of USD 65 billion in the year 2024. Also, favorable Government policies like 100% FDI and support for R&D create profitable opportunities for foreign businesses in this sector. However, earlier manufacturers of medical devices were free to sell their products in the Indian market without any stringent regulation process. But since 2006, all medical devices imported from overseas must comply with a mandatory process of medical device registration in India regulated by the CDSCO. Given below is a detailed overview of the various classes of medical devices and their registration process in India

Class A

All low-risk category products fall under this class. This includes thermometers, surgical dressings, bolster sutures, and more.

Class B

Medical devices that belong to moderate risk categories fall under class B, like hypodermic needles, suction equipment, forceps, rectal balloon, vial adapter, etc.

Class C

Medical devices that belong to the moderate-high risk category fall under class C; this includes bone fixation, vein ablation device, bone cement, etc.

Class D

This class includes all high risk-medical devices like a coronary stent, bifurcation stent, implantable devices, and more.

Categorization of Medical Devices in India

In accordance with recent reforms, medical devices are now categorized into four main groups based on their risk of use, further divided into surgical and non-surgical equipment.

RISK BASED MEDICAL DEVICE 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
	A, B	Loan License	Application: MD-4 Permission: MD- 6
	C, D	Manufacturing License	Application: MD-7 Permission: MD- 9
	C, D	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.

IMPORT LICENSE PROCESS

Classification of Medical Devices

Authorized Agent / Registration Holder Support

Aplication Filing (Form MD- 14)

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. ZYPS act as a medical device regulatory consultant and 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.

Authorized Agent / Registration Holder Permission for Import License (Form MD-14, Form MD-15)

The central licensing authority CDSCO requires the applicant to apply for an import license in form MD-14. The authorized agent can apply for the import license on behalf of the foreign manufacturing company in form MD-14. At ZYPS, we possess the valid wholesale license for sale or distribution of drugs to apply for medical devices import license on the behalf of a foreign manufacturer.

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

An importer/manufacturer can be permitted to import medical devices in small quantities for the purpose of testing, clinical investigations, demonstration or training. The rules requires the manufacturer to obtain a test license by applying for it using Form MD-16. Further, the test license for importing medical devices will be granted permission through Form-17. The technical team at ZYPS will guide you through this Medical Device Registration process and will help you in obtaining a respective test license for your medical device imports.

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.

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. ZYPS 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 C (Moderate to High Risk) and Class D (High Risk) medical devices falls under the authority of Central Licensing Authorities(CLA). Due the operational risk associated with Class C and Class D medical devices, the procedure for obtaining a manufacturing license for these devices is quite stringent.. With our extensive experience and deliberate approach including follow ups and meetings, we help our clients obtain the license in less time.

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

Manufacturers may sometimes also require license for production of medical devices intended for the purpose of testing, training, clinical evaluation or demonstrations. In this accord, an appropriate test license has to obtained by the Central Licensing Authority for manufacturing such devices. The test license can be obtained for any class of medical devices. Our technical team at ZYPS helps such clients by easing the process of filing the application and obtaining the test license.

INVESTIGATIONAL NEW DEVICE/ NEW DEVICE – 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).