An Overview of CDSCO Medical Device Registration in India
Currently, India is one of the top global medical device markets with a massive contribution from device imports. Earlier, the manufacturers in India could sell medical devices without any jurisdiction. Since 2006, medical devices entering India should be in compliance with the Indian Medical Device Regulations set by the CDSCO. Today, there is a proper system for Medical Device Registration in India for specific types of medical devices managed under the Medical Device Rules.
The CDSCO (Central Drug Standard Control Organisation) regulates medical devices in India and IVD (In-Vitro Diagnostics) marketed in India. The CDSCO is headed by the DCGI or Drug Controller General of India and the approval authority is shared between SLA (State Licensing Authority) and CLA (Center Licensing Authority). In India, the manufacturing, import, sale & distribution of medical devices are regulated under the Drugs and Cosmetics Act, 1940 and Rules 1945. So, it is necessary to obtain CDSCO Medical Device Registration in India.
Which Regulatory Bodies are Responsible for CDSCO Medical Device Registration in India?
Following are the main regulatory bodies that are responsible for CDSCO Medical Device Registration in India:
- The Drug Controller General of India (DCGI) is responsible for the manufacturing approval of certain drugs such as blood products, vaccines, large volume parenteral, r-DNA derived), specified medical devices, and new drugs;
- The CDSCO (Central Drug Standards Control Organisation0 is the main regulatory body in India for pharmaceuticals & medical devices;
- In India, the import, sale, manufacturing, and distribution of medical devices are regulated under India’s Drugs & Cosmetic Acts and Rules.
Classification of Indian Medical Device
Separate classification systems exist for IVD and Medical Devices in India, and each of these classifications are categorised into 4 different classes based on the extent of risk linked with these devices. Below is the table of 4 different categories of Indian Medical Device:
Low Moderate Risk
Who Can Apply For CDSCO Medical Device Registration in India?
Following is the list of who can apply for CDSCO Medical Device Registration in India:
- The Manufacturer has a registered office in India;
- The Authorized Agent of the Manufacturer;
- The Subsidiary of the Manufacturer ;
- Any other importer;
- Domestic Manufacturer.
Different Types of Applications for CDSCO Medical Device Registration in India
All the applications for CDSCO Medical Device Registration in India (Notified & Non-Notified Devices) must be submitted via an online website called SUGAM and CDSCO manages the applications via the same portal.
- Non-Notified Devices: These devices not included in the list of Notified Devices are not regulated in India. But, these devices shall be listed on the official website of CDSCO. Foreign or Overseas Manufacturers shall have an IAA based in India to market these devices.
- Notified Devices: There are 37 different categories of devices listed in Notified List, which are controlled by the CDSCO and also require prior approval from the CDSCO for marketing such devices in India. There are different types of application forms, and the documentation requirements vary with the application form for CDSCO Medical Device Registration submitted to the CDSCO.
Class of Device
Note: The choice of application varies on the home country approval, applicant’s nature, operations, availability of FSC (Free Sale Certificate), and the type of device.
Manufacture of Medical Devices - CDSCO Medical Device Registration in India
Step 1: Application for the license for manufacture of these notified devices in India shall be made in Form 27 to the SLA (State Licensing Authority), accompanied by the fee in the form & manner as prescribed in the proposed Rules along with a copy to the DCG Office.
Step 2: A 60 days of time would be given for making the application for manufacture from the publication date of these guidelines.
Step 3: In the case of devices belonging to the above-said categories which haven't been manufactured in the country before the notification date, no manufacture would be permitted henceforth without the competent authority's approval as per the norms prescribed.
Step 4: The applicant shall provide the following details along with the application to the licensing authority:
- Details of Manufacturing:
- Overall details like names, address of the company's directors and address of the manufacturing units and registered offices of the Manufacturer;
- A brief project enlighten showing the company's plan, a device to be manufactured, their viability & other important profiles;
- Copy of the Site Master File;
- Details of the standards followed by the company for product examination & Good Manufacturing Practices;
- Copies of ISO/any other certifications, if required, obtained by the firm for its manufacturing premises;
- A detailed explanation of the manufacturing process of the devices to be manufactured;
- Qualification, experience & name of technical staff under whose supervision the devices will be manufactured.
- Details of the Product:
- Brand or Proprietary name;
- Device category;
- Method of use and intended use;
- Brief description of the device;
- Specification of the materials used;
- Variations in style, size, or shape of the device, if applicable;
- Recommended storage conditions;
- Warnings, contraindications, precautions for potential adverse events and alternative therapy, wherever applicable;
- Summary indications of any reported problems;
- Quantitative & qualitative particulars of the constituents;
- List of accessories & other devices or equipment to be used in combination with the device. Other description information, comprising accessories packaged with the product;
- Packaging description comprising pack sizes;
- Labelling details conforming to Drugs & Cosmetics Rules, 1945;
- Promotional Literature & Physician manual in English;
- Medical speciality in which the device is used;
- Testing facilities are available in the manufacturing units for testing.
Step 5: For the examination of Medical Devices which are new or don't have any benchmark certification, the expert committees shall be established to examine in detail the information given by the applicant for the device assessment.
Step 6: The committee, after completing their assessment, forward the opinion regarding device suitability to the competent authority for the purpose of permission for placing the device on the market.
Step 7: The SLA, after the joint verification & inspection, would forward the license to CLAA for approval.
Step 8: The license shall be issued in Form 28 of the said rules after due approval of CLAA.
How Corpbiz Will Help You?
Medical Device Registration in India under CDSCO requires lots of requirements and documentation. New applicants may find it very difficult to comply with such requirements & documentation. Hence, in such a case, it is advisable to contact Coprbiz, who will guide you on each step of the licensing procedure. At Corpbiz, we simplify the process for our respected clients by addressing all the legalities on their behalf.
Frequently Asked Questions
The CDSCO is India’s primary legislative body for regulating and managing pharmaceuticals & medical devices.
Such devices are for internal or external use in the treatment, diagnosis, mitigation, or prevention of disease/disorder in human beings/animals, as may be determined from time to time by the Central Government of India through a notification in the Official Gazette after consultation with the Board.
CDSCO, DGHS, Ministry of Health & Family Welfare, and Medical & Diagnostics Division.
If the application is complete in all aspects & information specified in Schedules D-I and D-II are in order, the authority shall, within 9 months from the receipt date of the application, issue such Registration Certificate in Form-41.
It shall be valid for 3 years of time from the date of its issuance.
This depends on the various aspects and in a few cases, foreign clinical data is accepted.
In India, currently, only 40 to 50 medical devices require registration and for all other devices that don't require registration, the Manufacturer should get a NOC from the DCGI.
The devices are classified as Drugs for Importers or Manufacturers as per notification of CDSCO and must be voluntarily registered by CDSCO within 18 months from April 2020
Class I present minimal harm to human, Class II poses a higher degree of risk, and Class III applies to the high-risk types of medical devices.
All medical equipment are medical devices, but not all devices should be considered equipment.
Not all medical require a prescription, but many medical devices do require a prescription, such as contact lenses.