CDSCO Registration for Medical Devices

In the growth journey of the Indian medical device industry, innovative technology, skilled professionals, and a robust regulatory framework play pivotal roles. When individuals or firms aim to import medical devices from other countries, it’s crucial to comprehend the norms and regulatory procedures specific to those nations. As CDSCO medical device regulatory consultants, we offer comprehensive assistance throughout this process. Let’s delve into an overview of the CDSCO regulatory process.

India CDSCO medical device registration

CDSCO Overview

Every nation in the world has its own dedicated governing body under the ministry of health to look after every aspect of pharmaceutical and medical devices.

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

What are the Objectives of CDSCO?

  • Approval of new drugs and clinical trials.
  • Import licensing.
  • Manufacturing medical devices licensing.
  • Licensing of blood banks, vaccines and some medical devices.
  • Amendment to Drugs & Cosmetics Act and rules.

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. 

Medical Device Registration for Import

Medical devices entering India must comply with the Indian medical device regulations 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 activities of state drug control organizations. Operon Strategist assists medical device distributors and medical device wholesalers in Iran to procure CDSCO import license  for medical devices.

Who Can Apply?

To proceed, it’s necessary to designate an authorized Indian agent. This agent must hold a valid license for either manufacturing (for sale or distribution) or wholesale distribution. Additionally, they need to possess Form 20B and Form 21B licenses for the sale or distribution of medical devices, as stipulated by CDSCO guidelines. The agent will then submit an application via the Sugam online portal to obtain the import license for medical devices.

Application Process to Grant Indian Import License

The application process for obtaining an import license for medical devices in India involves the following steps:

1. Prepare required documentation.
2. Appoint an authorized Indian agent.
3. Submit the application online through the Sugam portal.
4. CDSCO reviews the application for compliance.
5. Inspections may be conducted if necessary.
6. Upon approval, CDSCO issues the import license.
7. Adhere to post-approval obligations for ongoing compliance.

It’s essential to stay updated on any changes in regulatory guidelines from CDSCO.

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 error free result within timeframe. Also, We provide regulatory assistance to our clients for importing and exporting medical devices from Iran.

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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).