Welcome to our dedicated CDSCO registration services, your one-stop solution for navigating the complex regulatory landscape of the Central Drugs Standard Control Organization (CDSCO) in India. Our experienced team offers comprehensive support to assist you in obtaining the necessary approvals and licenses for your medical devices, pharmaceuticals, or cosmetics.

Overview of CDSCO and Its Role in Medical Device Regulation

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory body responsible for overseeing the registration, sale, and regulation of notified medical devices. As a division of the Directorate General of Health Services within the Ministry of Health and Family Welfare, the CDSCO ensures the quality, safety, and performance of medical devices across the country. By implementing stringent standards, guidelines, and approval processes, CDSCO aims to align India’s medical device regulations with global standards, fostering trust and safety in healthcare.

cdsco registration

Medical Device Registration for Import:-

Medical Devices entering India must be in compliance with the Indian medical device regulation set forth by the CDSCO for Registration. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, controlling the quality of imported drugs, and coordinating the activity of State Drug Control Organizations. Operon Strategist assists medical device distributors and medical device wholesalers in Costa Rica to procure CDSCO import licenses for medical devices.

Objectives of CDSCO

The key objectives of the CDSCO include:

  • Approval of new drugs and clinical trials
  • Import licensing
  • Licensing of manufacturing of medical devices
  • Amendment to Drugs and Cosmetics Act and rules
  • Classification of Medical Devices

In line with the Medical Device Rules 2017, medical devices are classified into Class A, Class B, Class C, and Class D based on their level of risk. Understanding this classification is essential for successful registration and import of medical devices in India.

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Classification of Medical Devices as per CDSCO:

MDR 2017 has categorized the devices as Class A, Class B, Class C and Class D. Below table will spread some light on classification of medical devices.

 
 
 
 
 
 

Type 

 
 
 
 

Risk 

 
 
 
 

Example 

 
 
 
 

Class-A 

 
 

Low risk 

 
 

Bandage, examination loves etc. 

 
 
 
 

Class B 

 
 

Low-Medium Risk 

 
 

B.P. monitoring device, thermometer 

 
 
 
 

Class C 

 
 

Moderate to High Risk  

 
 

Implants, catheter 

 
 
 
 

Class D 

 
 

High Risk  

 
 

Heart Valve. 

Import License Application Process

Securing an import license for medical devices in India requires navigating a complex and meticulous application process to comply with the regulations set by the CDSCO. Our team at Operon Strategist specializes in guiding both foreign and Indian companies through this intricate process. We assist with every aspect of document preparation, from compiling technical files to ensuring that all required certificates and product details meet the CDSCO’s stringent requirements. Leveraging our expertise not only streamlines the application but also helps mitigate potential delays or rejections by ensuring compliance at every stage. Our comprehensive support is designed to make the import license application as seamless and efficient as possible, allowing clients to focus on entering or expanding in the Indian market confidently.

Our Role in CDSCO Registration

Navigating the CDSCO registration process can be complex, which is why our team of regulatory consultants specializes in providing expert guidance. We ensure error-free results within the required timeframe and offer regulatory assistance for importing and exporting medical devices from Costa Rica. Contact us today for efficient and reliable CDSCO registration services.

We also provide medical device consultation for India, Saudi Arabia, the USA, the UK, South Africa, Oman, Iran & Egypt. Feel free to contact us.

FAQs

For the import of cosmetics in India, the imported cosmetics products are required to be registered with Central Drugs Standard Control Organization (CDSCO).Cosmetic products and color additions do not need FDA approval before they go in the market. Although they should not be contaminated or misbranded. It means that they should be safe for the customers under labeled customary conditions to use, and they must be properly labeled. In the case of color additions and those ingredients which are banned or restricted by FDA regulations, a cosmetic firm can use any ingredient as long as it does not cause the product to be contaminated.

IEC Import Export Code is the first requirement you before you start an import/export code in India. An IEC is important for the import and export of goods. The IEC is issued by the Directorate General of Foreign Trade (DGFT) Ministries of Commerce and Government of India. For releasing any medical device the manufacturer has to attach to various rules set by the national regulatory bodies of India. The main regulatory body of India is Central Drugs Standard Control Organization (CDSCO). It is under Directorate General of Health Services, Ministry of health and family welfare. Under the drugs and cosmetics act CDSCO is responsible for the approval of drugs, conduct of clinical trials, laying down the standard of drugs, control over the quality of imported drugs, in the country. Further CDSCO along with state regulators is jointly responsible for granting licenses of certain specialized categories of critical drugs such as blood and blood products I.V. Fluids, Vaccine and sera.

Ans-Yes. Under the provision of Drugs and Cosmetic act 1940, registration certificate and import license are required to import in India. For the introduction of medical device in the Indian market, the Manufacturers has to obey various norms set by national regulatory bodies of Saudi Arabia. The main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices are submitted to Central Licensing Authority, where the (DCGI) Drug Controller General of India takes the responsibility for approval of Manufacturing, Registration, Import and Sale of Medical Devices in Saudi Arabia. When the Medical Device released to be imported it has some issued steps to be followed. The importers may also get the respective sale license from the State Licensing Authorities (SLA).