Medical Devices Import Regulations in India

The healthcare system that we see today has evolved and will continue to do so. Medical devices serve a major part in this. In a healthcare system where medical devices are unavoidable, it is the duty and responsibility of the regulatory authority to assure and maintain the medical devices in their highest state of quality, safety and efficacy. In India, Central Drug Standard Control Organisation (CDSCO) regulates the medical device sector.

Medical devices sector in India is still developing and most of the devices are being imported. There are Indian medical device regulations to be strictly complied with while importing devices into India. This article speaks about import license regulations, registration requirements, common challenges, strategies to streamline them and more.

Regulatory Framework for Import of Medical Devices to India

Since medical devices have different levels of risk, a stringent regulatory framework has been developed based on the risk level for regulation of medical devices. To import medical devices into India, there are certain rules and regulations to follow, documents to submit and other activities to be conducted as demanded by the CDSCO for ensuring product safety and quality.

Medical Devices Import Regulations In India

Importing medical devices into India falls under the purview of the CDSCO, which regulates the quality, safety, and efficacy of medical devices entering the country. The regulatory framework includes guidelines for registration, labeling requirements, quality control, and post-market surveillance to ensure compliance with Indian standards while safeguarding public health. To import medical devices to India registration is required.

Registration Requirements For Medical Devices In India

The requirements for registration of medical devices on the Online System for Medical Devices established by CDSCO is given below. This is for medical devices other than those for in schedule eight of the Medical Device Rules, 2017 are as follows:

• Name and address of the medical device manufacturing company.

• Name and address of manufacturing site of the medical device

• Details of the medical device which includes Generic name, model number, intended use, medical device class, construction material used, shelf life, sterile or non-sterile, brand name (if registered under Trademarks Act 1999), dimensions (if any).

• Compliance Certificate with respect to ISO 13485

• Free Sales Certificate from the country of origin

• Undertaking duly signed by importer. It must state that the information provided by the applicant is true and authentic.

 

Import License for Medical Device in India

For the import of medical devices to India, an Import License for medical device is essential. An application for the grant of import license must be made in Form MD-14 and the license is granted in Form MD-15. The application is submitted to Central Licensing Authority (CLA) via an online portal (SUGAM). Any amendments to the documents submitted at the time of application or before the grant of license must be informed to the CLA in writing.

 

The fee structure for the import of medical devices is given below:

Import License	Per Site/ Each distinct device	Fee to be Paid
Class A (Other than non-sterile and non-measuring)	Per Site	$1,000
Each distinct device	$50
Class B	Per Site	$2,000
Each distinct device	$1,000
Class C	Per Site	$3,000
Each distinct device	$1,500
Class D	Per Site	$3,000
Each distinct device	$1,500
Fee to import investigational medical device by the government hospital or statutory medical institution for the purpose of patient treatment for each distinct medical device	Each distinct device	Rs 500

Requirements for the Import of Medical Devices to India

For importing medical devices to India, the following documents are to be submitted along with Form MD-14:

• A covering letter

• An application made in Form MD-14

• Fee challan

• The Power of Attorney together with an undertaking form the authorized agent according to Fourth Schedule, part I of MDR 2017

• Copy of: Manufacturing license/wholesale license/ Registration Certificate in Form MD-42

• Regulatory Certificates (Free Sales Certificate, latest audit reports, overseas manufacturing site/ plant registration…)

• Authorised agent constitution details

• Quality certificate with respect to the actual manufacturing site (certificate copy supporting the quality management system, Full Quality Assurance Certificate copy, CE product quality assurance certificate, declaration of conformity issued by manufacturer…)

• Plant Master File

• Device Master File

• Any other additional relevant documents

 

What Happens After I Submit My Application for an Import License?

After the receival of the application, the CLA conducts an inspection of the overseas manufacturing site. A fee shall be paid by the applicant in connection to the expenditure for the visit of overseas manufacturing site as specified under MDR 2017, second schedule. If the CLA is satisfied, the license is granted in Form MD-15. The application can be rejected, if not satisfied and the reason will be stated in writing within a 9-month period from the date of application.

Common Challenges Faced by Importers

Regulatory Approval Delays

The major challenge is the delay in the regulatory approval process. For instance, if Class C and D medical devices do not have a Free Sales Certificate issued by the National regulatory authority or competent authority of certain countries like Australia, USA, EU countries, Canada, Japan, then it is required to conduct clinical investigation of the device in India. Such regulatory requirements call for a delay in regulatory approval and market entry.

As we know the requirements of the regulatory change from time to time and new procedures or standards can be implemented any time. So, a delay does not only mean that the device will get approved after some time it also have the possibility that if any standards are set forth, then due to the delay and according to the effective date of any new law implemented, the product will have to comply with the new standard too.

Complex Registration Procedures

Importers, most of them are foreign to the CDSCO regulations for medical devices. When comparing to the country where they use to run business, India might have exhaustive documentation or other registration procedures. Moreover, understanding the registration requirements, complaincing with them, appointing an Authorized Agent can be challenging to them.

Stringent Quality Standards

Since there is an import of quite a fair amount of medical devices into India, it is the responsibility of the regulatory authority to make sure that quality products are being imported into the country. To satisfy this condition, robust quality control standards are set by the authority. Rejections, product recalls, legal implications and brand reputation damage are the results extracted when failed to comply with the quality standards.

Medical Device Patent In India

As per Chapter II, Section 3 of The Indian Patent Act, patenting of medical devices are a challenge. Any process regarding the surgical, curative, medicinal, diagnostic, prophylactic or other treatment of human beings that render free of disease and any re-arrangement, duplication or mere arrangement of the known medical devices in a known way, where each functioning independently are some of the rules stated in this section.

Another challenge can be the affordability of the infrastructure. Hospitals in cities have the facility to adopt this device whereas in small clinics or in rural areas, they either won't have the facility to make use of it, lack of maintenance compared to major hospitals.

Some other challenges can be the requirement of an import license, documentation process, understanding cultural differences...

Strategies to Streamline the Import Process

The import of medical devices to India can be challenging and confusing and this can be more complex for importers new to the CDSCO medical device regulations. However, there are some strategies that can be implemented for a smooth import process which are discussed below.

Engage Local Regulatory Experts

Streamline the import process by:

• Leverage local agents.

• Local agents may have connections within CDSCO to know accurate information which can be useful to know what stages can be omitted (if any) at an early stage or does any of the document you own can serve as an advantage in your regulatory journey.

• Take opinion from them in each regulatory stage rather than acting on your knowledge from prior regulatory bodies that you have worked with.

• Arrange consultation meetings with CDSCO

Conduct Thorough Due Diligence

To understand the regulatory framework and the market of a specific country, an investigation can be carried. This helps to understand:

• What you are dealing with (regulations)

• Requirements specific to the country

• Get an idea about the time, fee and documents needed

• Possible risks that can arise and ways to tackle it

• How to get your device faster into the market.

 

Establish Robust Quality Assurance Systems

To assure safety, quality and effectiveness of the products is not being compromised anywhere along the process, implement:

• Timely quality audits, internal and external

• Develop proper risk management plan

• Establish new and effective testing methods if existing ones are ineffective.

• Continue checking old test methods from time to time

• Document verification

• Come up with a strong quality assurance system

Medical Device Rules, 2017 (MDR)

• Introduction of MDR 2017 provides with clear safety, efficacy and quality regulatory requirements and rules making it easier for the importers to comply with and thereby expediting the Indian market entry of their product.

National Medical Device Policy, 2023

• This policy aims to accelerate the medical device sector growth.

• Promoting quality, affordability, skilled manpower, preventive and promotive health are some of the missions of this policy which benefit the medical device importers.

 

In Conclusion

India’s medical device industry is a promising sector of growth within the healthcare system. But to make an entry into this sector requires to follow a robust stringent guideline which can be challenging. With proper planning, adoption of regulatory experts and with a strategic approach, the medical device importers can streamline their way through the complex Indian medical device regulations.

Artixio, a leading global regulatory partner, can help you with medical device import into India. We are specialized in providing services in medical devices along with pharmaceuticals, cosmetics, biologics, food supplements and veterinary sectors. Our regulatory experts with 15-35 years of regional experience to expedite the import of medical devices into India.

FAQ’s

Q. Who governs the import of medical devices to India?

The import of medical devices in India is overseen by the Central Drugs Standard Control Organisation also known as CDSCO.

Q. Can foreign manufacturers import their product directly in India?

No, foreign manufacturers must appoint a local agent, the Authorised Agent. Through the authorised agent, the foreign manufacturers can make an application to import medical devices into India.

Q. What are the details to be added by the stickering if not already in the label for imported medical devices?

The details to be added by stickering method are import license number, name and address of the imported, address of the actual premises where the manufacturing is done and finally the date of manufacturing.

Q. What is the validity for the import license for medical devices in India?

The validity of an import license remains to perpetuity if the license retention fee has been submitted every 5 years, after the due date but before expiry date of the license, from the date of license issued.