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CDSCO Import License for Medical Devices- An Overview
The Central Drugs Standard Control Organisation (CDSCO) is India's National Regulatory Authority (NRA) under the Ministry of Health and Family Welfare, overseen by the Directorate General of Health Services. Under the Drugs and Cosmetics Act, CDSCO import license for medical devices in India are mandatory.
The Drugs and Cosmetics Act of 1940 and the Rules of 1945 assign various responsibilities to both central and state regulators for overseeing drugs and cosmetics. CDSCO ensures the uniform implementation of these regulations to safeguard patient safety, rights, and well-being.
All medical devices imported into India must comply with the Indian medical device regulations set by CDSCO. Therefore, obtaining a CDSCO import license for medical devices is mandatory, as it provides legal approval that the products meet the required standards for quality and safety. Our CDSCO import license consultants at Fastzeal will help you get the license as soon as possible without any worry.
What are Medical Devices?
According to the Medical Device’s Rules,2017, medical devices refer to substances used for vitro diagnosis, surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, and blood and blood component collection bags with or without anticoagulant.
Additionally, medical devices also include mechanical contraceptives, disinfectants, and insecticides. Subsequently, medical devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in animals or humans.
According to Medical Devices Rules,2017 medical devices are classified into four classes based on risk parameters such as:
- Low Risk- Class A
- Low Moderate Risk-class B
- Moderate High Risk- Class C
- High Risk- Class D
Who Can Apply for CDSCO Import License Medical Device?
Get a glimpse of those who are eligible to apply for CDSCO import license in India:
- An authorized legal entity
- Importers
- Indian Agents
- Foreign enterprises with Indian subsidiary
- Corporate
Market Size for Medical Devices in India
India's healthcare and medical devices industry has experienced significant growth over the past decade. The sector includes multinationals, small, and midsized companies. In 2022, the market size of medical devices in India was approximately Rs. 90,000 crore (US$11 billion), with projections to reach US$50 billion by 2030, growing at a CAGR of 16.4%. Despite this growth, India holds only a 1.65% share of the global market.
India is the 4th largest medical device market in Asia, following Japan, China, and South Korea, and ranks among the top 20 globally. Between November 2022 and October 2023, India's dependence on imported medical devices increased by 21%, with imports totalling Rs. 61,262.84 crore (US$7.23 billion).
Role of CDSCO in Import License for Medical Devices
CDSCO stands for Central Drugs Standard Control Organization under the Directorate General of Health Services, Ministry of Health and Family Welfare, government of India. CDSCO is a regulatory body that is responsible for giving approval to new drugs as well as conducting clinical trials, and setting standards for CDSCO medical device import license in India.
The objective of CDSCO is to bring out transparency, accountability, and uniformity in their services ensuring a safety, efficiency, and quality of the medical products that are manufactured, imported distributed within the Indian territory.
CDSCO Import License for Medical Devices- An Overview
The Central Drugs Standard Control Organisation (CDSCO) is India's National Regulatory Authority (NRA) under the Ministry of Health and Family Welfare, overseen by the Directorate General of Health Services. Under the Drugs and Cosmetics Act, CDSCO import license for medical devices in India are mandatory.
The Drugs and Cosmetics Act of 1940 and the Rules of 1945 assign various responsibilities to both central and state regulators for overseeing drugs and cosmetics. CDSCO ensures the uniform implementation of these regulations to safeguard patient safety, rights, and well-being.
All medical devices imported into India must comply with the Indian medical device regulations set by CDSCO. Therefore, obtaining a CDSCO import license for medical devices is mandatory, as it provides legal approval that the products meet the required standards for quality and safety. Our CDSCO import license consultants at Fastzeal will help you get the license as soon as possible without any worry.
What are Medical Devices?
According to the Medical Device’s Rules,2017, medical devices refer to substances used for vitro diagnosis, surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, and blood and blood component collection bags with or without anticoagulant.
Additionally, medical devices also include mechanical contraceptives, disinfectants, and insecticides. Subsequently, medical devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in animals or humans.
According to Medical Devices Rules,2017 medical devices are classified into four classes based on risk parameters such as:
- Low Risk- Class A
- Low Moderate Risk-class B
- Moderate High Risk- Class C
- High Risk- Class D
Who Can Apply for CDSCO Import License Medical Device?
Get a glimpse of those who are eligible to apply for CDSCO import license in India:
- An authorized legal entity
- Importers
- Indian Agents
- Foreign enterprises with Indian subsidiary
- Corporate
Market Size for Medical Devices in India
India's healthcare and medical devices industry has experienced significant growth over the past decade. The sector includes multinationals, small, and midsized companies. In 2022, the market size of medical devices in India was approximately Rs. 90,000 crore (US$11 billion), with projections to reach US$50 billion by 2030, growing at a CAGR of 16.4%. Despite this growth, India holds only a 1.65% share of the global market.
India is the 4th largest medical device market in Asia, following Japan, China, and South Korea, and ranks among the top 20 globally. Between November 2022 and October 2023, India's dependence on imported medical devices increased by 21%, with imports totalling Rs. 61,262.84 crore (US$7.23 billion).
Role of CDSCO in Import License for Medical Devices
CDSCO stands for Central Drugs Standard Control Organization under the Directorate General of Health Services, Ministry of Health and Family Welfare, government of India. CDSCO is a regulatory body that is responsible for giving approval to new drugs as well as conducting clinical trials, and setting standards for CDSCO medical device import license in India.
The objective of CDSCO is to bring out transparency, accountability, and uniformity in their services ensuring a safety, efficiency, and quality of the medical products that are manufactured, imported distributed within the Indian territory.
CDSCO Medical Device Import License Functions
CDSCO import registration for medical devices in India is accompanied by several functions, as given below:
- CDSCO issues a registration certificate in form 41 for bulk drugs and finished products.
- Issuance of CDSCO import license for medical devices like bulk drugs and finished formulation in form 10 or 10 A.
- Issuance of NOC (No Objection Certificate) for shelf-life extension meant for export of drugs specified in Schedule P.
- It grants repacking permission as per rule 37 of the Drugs and Cosmetics Act, 1940 & rules 1945 packing of patent or proprietary medicines.
- Post-approval change application processing.
- Issuance of CDSCO NOC for import of duty-free medicines for charitable purposes.
- It coordinates with Zonal/Subzonal/Port offices (By Sea and By Air respective import of chemical drugs)
Benefits of CDSCO Import License for Medical Devices in India
The benefits of CDSCO import license for medical devices in India are as follows:
- CDSCO medical device import license ensures that the import of medical devices in India has fulfilled the necessary laws and regulations.
- It ensures product safety, ensuring safety measures that are free from harmful substances, making them safe and secure for public use.
- It gives quality assurance to the devices that are imported into India, ensuring they are suitable for widespread use.
- Obtaining a CDSCO import license for medical devices in India opens up new opportunities for businesses to ensure products are free and toxin-free.
- CDSCO certificate for medical devices ensures consumer protection, maintaining a quality standard with the objective of the well-being of consumers, assuring them that their medical devices are safe and secure for use.
Requisites for CDSCO License Registration for Medical Devices
Here, given below is the list of requisites for CDSCO license registration for medical devices in India:
- The applicant must provide a unique generic brand name for the medical device.
- A description of the medical device.
- A list of details on the construction of the medical device and its safety measurement.
- A mode of application on how medical devices are to be used.
- Details study regarding the devices and their classification of the medical devices based on the risk factors.
Documents Required for Medical Device Import License
If you are engaged in the business of importing medical devices, you must have a thorough understanding of the documentation needed for CDSCO import registration. The documents required for the import license CDSCO for medical devices are as follows:
- Covering Letter
- An Authorization Letter from the Director/Company Secretary/Partner.
- A duly filed Form MD-14.
- A duly filled and notarized form 9 authenticated from the Indian Embassy of the country of origin.
- A valid copy of the registration certificate in Form 41 issued by CDSCO.
- Applicant must have a Wholesale License for the sale or distribution of drugs under Drugs and Cosmetics.
- A valid copy of the Free Sale certificate or Certificate to Foreign Government or certificate of Marketability for each drug issued by the National Drug Regulatory Authority of the country of origin.
- Manufacturing license and or market Authorization certificate issued by the National Drug Regulatory Authority of the country of origin.
How to Apply for CDSCO Medical Device Import License Online?
The CDSCO import license online for medical devices is obtained through an online platform, here given below is the stepwise procedure on how CDSCO import license in India is granted:
- Firstly, the applicant must visit the online SUGAM portal for CDSCO import license for medical devices.
- Secondly, file an application in Form MD-14 along with the mandatory documents along with the required fees.
- Thirdly, the application submitted shall be reviewed or evaluated by the concerned Drugs inspector or Assistant Drugs Inspector.
- Followed by evaluations by the deputy drugs controller then forwarded to the Joint drugs controller.
- Lastly, an approval or rejection of CDSCO import license for medical devices shall be issued by the drug controller general of India.
Regulations for CDSCO Import License for Medical Devices
The regulations for CDSCO import license for medical devices ensure that such imported medical devices meet the regulatory standard and safety measures to make them available for public use. These regulations are governed under Central Drugs and Cosmetics Act, 1940, and the Medical Device Rules, 2017.
According to CDSCO regulation, a company or individual holding a wholesale license (Form 20/21B) or a CDSCO registration certificate (Form 41/42) can apply for CDSCO import license for medical devices in India. However, obtaining an import license CDSCO is mandatory for importing medical devices in India.
On the other hand, foreign manufacturers are not eligible to directly apply for CDSCO import license in India. However, they have to appoint an authorised agent or importer in India to obtain CDSCO registration for medical devices.
Additionally, the requirement of documents for CDSCO import license for medical devices has been precisely mentioned in the amendments and the validity of CDSCO import license for medical devices will be for 5(five) years from the date of license issued.
Licensing Authorities for CDSCO Medical Device Import License
The licensing authorities for CDSCO import registration in India are as follows:
1. State Licensing Authority (SLA)
The State Licensing Authority is responsible for issuing license for medical devices and IVDs that fall under Class A & B and engage in manufacturing, loan, and wholesale licenses.
2. Central Licensing Authority (CLA)
The Central Licensing Authority is responsible for issuing CDSCO import license for medical devices and IVDs, manufacturing, loan, and wholesale license that categorically fall under Class C & D as well as an import license for cosmetics in India.
Penalty for Non-Compliance with CDSCO Import License
Non-compliance with the CDSCO import license for medical devices can lead to serious legal consequences under the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017.
Penalties may include imprisonment, fines, or both, if medical devices are imported without proper approval or if false information is provided. Additionally, the import license CDSCO may be suspended or cancelled for failure to comply with the laws and regulations, ensuring that imported medical devices meet the required safety and quality standards.
Our CDSCO import license consultants ensure no penalty and full compliance support.
Timeline for CDSCO Medical Device Import License
According to the CDSCO guidelines, the overall timeline for a CDSCO medical device import license in India is 270 days. However, given below is the list of how this 270-day is distributed:
- Document preparation and Submission (30-45 days)
- Initial Review by CDSCO (45-60 days)
- Query Resolution by CDSCO (15-30 days)
- Evaluation & Classification of Risk (60-90 days)
- Approval Process & License Issuance (60-90 days)
Why Fastzeal for CDSCO Import License for Medical Devices?
Apply for a CDSCO Import License for medical devices in India with the help of our CDSCO import license consultants. We have a team of experts who have honed experience in providing licenses to businesses in the imported medical device segment. We offer businesses a way to deal with the complexities effectively involved with a CDSCO medical device import license, thus saving time and money by reducing the potential risks.
Given below are the reasons that make medical device business enthusiasts trust Fastzeal for CDSCO import license for medical devices in India-
Frequently Asked Questions:
The license for import of medical devices in India is a regulatory authorization that are granted by Central Drugs Standard control organisation (CDSCO). CDSCO is a regulatory body to authorised the businesses to issue a license for import of medical devices in India
Importers, Indian agents, foreign enterprises holding Indian subsidiaries, and corporates are eligible to apply for CDSCO license in India. It is recommended to take the help of CDSCO Import License Consultant for error-free procedure.
The Class 3 medical devices are those devices that amount to high risk to patients or users. These medical devices usually sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury. For example, breast implants, pacemakers, fetal blood sampling monitors, etc.
The validity of the CDSCO medical device import license will be 5 years from the license issued.
The medical devices in India is approved by the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
Class 1 medical devices are low-risk devices that have minimal contact with patients and have a low impact on patients’ overall health. For example, electric toothbrush, tongue depressor, oxygen mask, bandages, etc. Whereas, class 2 medical devices are intermediate-risk devices that are more complicated than class 1 and are more likely to come into sustained contact with a patient for example catheters, blood pressure cuffs, syringes, pregnancy test kits, etc.
CDSCO certificate for medical devices is mandatory approval that businesses dealing with medical devices must obtain from CDSCO. This certificate ensures that the respective medical device is safe and secure for public use.
The import license for medical devices in India is regulated under the Central Drug Standard Control Organisation (CDSCO).
The Form MD-14 of CDSCO is to be filled by an applicant to get permission to import medical device licenses based on various categories. On the other hand, Form MD-15 is a license that is granted by CDSCO that grants legal permission to bring medical devices to India.
