Indian CDSCO Medical Device Registration

Innovative technology, proficient and technically expert people, finest regulatory framework are the contributing factors to the growth of the Indian medical device industry. When a person / firm wants to import devices from another country, they should understand the norms and regulatory procedures of that specific country. As a CDSCO medical device regulatory consultant we provide full assistance in the process. Let’s understand CDSCO regulatory process in brief.

CDSCO Registration Consultant in South Africa

Indian CDSCO Overview:

The Central Drugs Standard Control Organization (CDSCO) is India’s national cosmetics, pharmaceutical, and medical device regulatory authority.

The CDSCO is responsible for regulating the registration & sale of notified medical devices in India. CDSCO is controlled and governed by the Directorate General of Health Services which comes under the Ministry of Health and Family Welfare Government of India.

What are the Objectives of CDSCO Objectives?

The objectives of CDSCO (Central Drugs Standard Control Organization) regarding medical devices in India are to:

  1. Ensure the safety, efficacy, and quality of medical devices.
  2. Approve and regulate the import, manufacturing, and sale of medical devices.
  3. Set and enforce quality standards, including Good Manufacturing Practices (GMP).
  4. Monitor device safety through post-market surveillance.
  5. Regulate clinical investigations and trials.
  6. Control import and export of medical devices.
  7. Align with international standards for harmonization.
  8. Educate healthcare professionals and the public on device use.
  9. Collaborate with global regulatory agencies.
  10. Improve regulatory efficiency and timeliness.

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Classification of Medical Devices as per Indian 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. 

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 the South-Africa to procure CDSCO import licenses for medical devices.

Application Process to Grant Indian Import License:

An Import license is issued for the import of medical devices from South Africa to India. Both the foreign company and the Indian company jointly need to submit the documentation for the medical device and manufacturing unit. Process in brief:

  • Appointment of an authorized agent having the license for sale or distribution in India, eligible to make an application to grant import license.
  • Submission of the documents along with the application.
  • After examining the documents along with the application based on the inspection report, if the inspection has been done by the Central Licensing Authority and can be satisfied, grant the license in Form MD-15/26.

Operon Strategist's Role in CDSCO Registration?

CDSCO registration process may look simple and easy but the reality is that one need an expert regulatory consultant to complete this registration process.  As a CDSCO registration consultant we make sure that the clients will get errorfree result within timeframe. Also,We provide regulatory assistance to our clients for importing and exporting medical devices from South-Africa. We are expert consultation firm for providing CDSCO (Indian Import License) regulatory services for India, Saudi Arabia & Egypt. 

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).