CDSCO Overview :
Medical Devices
Cosmetics
In Vitro Diagnostics Kits
At the federal government level in India, all Medical Devices, Drugs, Cosmetics and IVDs are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO (can be referred to Indian FDA) for Form MD-15 Import license or Indian Medical Device approval. The CDSCO is responsible for registration, approval and regulation of New Drugs and Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Manufacturers can leverage their approvals in the United States of America (USA), United Kingdom (UK) Canada, European Union, Australia or Japan for the Registration process in India.
1. Medical Devices:
Earlier, manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical devices entering India must be in compliance with the Indian Medical Device Regulation Guidelines under the Medical device Rules, 2017 (MDR 2017 – DCGI) has been set by the CDSCO (Indian FDA). In India, for marketing of imported medical devices which come under the notified category, Import license in Form MD-15 is required under the regulation of Drugs and Cosmetics Act, 1940 and the newly published Indian Medical device Rules, 2017 (MDR 2017 – DCGI).
For Medical Device Registration in India, previously 37 device categories have been listed as ‘Notified Medical Devices’ as per the Indian Medical Device regulation Guidelines set by the CDSCO under the Medical device Rules, 2017 (MDR 2017 – DCGI). However, from 2020 ALL the medical devices except those under the low risk non-sterile and non-measuring category are notified within the CDSCO and require import license in Form MD-15 to sell in India.
A team of regulatory consultants specialized for medical devices at Morulaa can assist in determining whether your medical device requires regulatory or Approval license, MD-15 Import License in India, the risk classification it would fall under, predicate device analysis and pathway for registration in India. Some of the examples of medical devices which undergo regulatory Registration and Medical Device approval process in India include spinal needles, cochlear implants, annuloplasty rings, tracheostomy tubes, syringes and needle, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, catheters, surgical instruments, ultrasound devices, digital thermometers, nebulizers and ventilators, among others. Please contact us for a complete list of Notified Medical Devices in India along with their proposed risk classification in India.
Risk Classification in India:
Now ALL medical devices except for the Class A – non-sterile and non-measuring come under the notified licensing regime with the CDSCO as per the Indian Medical Device Regulations Guidelines. Medical devices under the First Schedule of new Rules “Medical device Rules, 2017 (MDR 2017 – DCGI)” are Classified as per Global Harmonization Task Force (GHTF) based on the intended purpose of the medical device. There are four risk classifications defined by the CDSCO in India,
- Class A (low risk)
- Class B (low moderate risk)
- Class C (moderate high risk)
- Class D (high risk)
Timeline and Validity:
The time period for Registration of Medical Devices in India is generally 6-9 months, post the submission of complete and accurate regulatory dossier and fees in the SUGAM portal to obtain the registration / Medical Device Approval, MD-15 Import license as per the Indian Medical device Regulations Guidelines set by the CDSCO. CDSCO Registration is valid for perpetuity and renewal applications (re-registration) need to be submitted every 5 years with supporting documents and government fee at actuals under the Medical device Rules, 2017 (MDR 2017 – DCGI) .
2. Cosmetics:
For the import of cosmetics into India, the cosmetic products need to be registered with the central licensing authority (CDSCO) as defined by the Guidelines under Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. To apply for an Import Registration Certificate for cosmetics intended for obtaining the import license into India, one must submit an application online through the SUGAM Portal of the CDSCO using Form COS-1 as per the Indian Medical Device Regulations for approval. The application, along with the necessary fee and supporting documents, should be submitted either by the authorized Indian agent or to the Central Licensing Authority, the CDSCO under the Cosmetics Rules, 2020, specifically the Drugs Controller General (I), CDSCO (HQ). The cosmetic registration certificate for import is granted in Form COS-2. The application for cosmetic registration in Form COS-1 is submitted along with a covering letter, authorization from the manufacturer, second schedule detailing the ingredient list, labeling, safety specification, test protocols and report, Free sale certificate, and declarations against animal testing, harmful substances and heavy metal as mentioned under Drug and Cosmetics Act,1940 by the CDSCO.
The full list of documents required for submission and the labeling requirements for importing cosmetics into India mentioned in the Guidelines set by the CDSCO under the Drug and Cosmetics Act,1940 by The CDSCO in the SUGAM portal is explained in the Step by Step process of Cosmetic Registration. The Cosmetics that are supposed to be imported are categorized into Brands.
These Brands are Divided into 4 Main Categories Namely:
- Skin Products
- Hair and Scalp Products
- Cuticle Products
- Oral Hygiene Products
Timeline and Validity:
The cosmetic registration certificate for import is issued in Form COS-2. The timeline to process this application is 90 days from the time of submission to the CDSCO of the registration application through the SUGAM portal, provided all documents are complete and in order. The validity of the cosmetic registration certificate, Form COS-2, is perpetuated, provided that the registration certificate retention fee specified in the Third Schedule is paid before five years from the date of issuance. However, this validity can be suspended or canceled by the CDSCO, Central Licensing Authority of India. If the registration certificate holder does not pay the retention or Re-Registration fee by the due date as per the Guidelines of Indian Medical Device Regulations, they must also pay a late fee of two percent of the retention fee for each month or part thereof, within a grace period of 180 days. Failure to pay the fee within this timeframe will result in the automatic cancellation of the registration certificate.
3. In Vitro Diagnostics Kits:
In vitro diagnostics (IVD) kits / reagents are classified on the basis of parameters specified by the CDSCO in Part II of the First Schedule of the India under the Medical device Rules, 2017 (MDR 2017 – DCGI). The classes are,
- Class A (low risk)
- Class B (low moderate risk)
- Class C (moderate high risk)
- Class D (high risk)
IVD such as “In-Vitro Diagnostic Devices for HIV, In-Vitro Diagnostic Devices for HBV, In-Vitro Diagnostic Devices for HCV and In-Vitro Blood grouping sera are considered highest risk diagnostic devices. Please contact us for a complete list of regulated In vitro diagnostics Medical Devices in India along with their proposed risk classification in India.
For the import of In Vitro Diagnostics (IVDs) Kits in India, an application in Form MD-14 is made along with the performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83 mentioned by the CDSCO. Class A IVDs do not require to conduct a performance evaluation with an Indian lab.
Timeline and Validity:
The time period for Registration of IVDs in India is generally 6-12 months after the submission to the CDSCO in the SUGAM portal. This is dependent on the risk class of the IVD and complete / accurate regulatory dossier compilation and fees to obtain the Medical Device Approval or MD-15 import license as per the guidelines of the Indian Medical Device Regulations under the Medical device Rules, 2017 (MDR 2017 – DCGI). Registration is valid for perpetuity and renewal applications (re-registration) need to be submitted every 5 years with supporting documents and government fee at actuals.
CDSCO Regulatory Challenges in India:
Manufacturers of medical devices, cosmetics, IVDs are attracted to the Indian market due to its reliance on imports. However the challenge is that the CDSCO, the Regulatory Body of India is currently at its infancy and rules may be updated within short periods resulting in uncertainty over the Medical Device approval process.
The general timeline followed by the CDSCO for the various process of approval of MD-15 Import License, trials, applications can be found – CDSCO Timelines. Contact Harshita Gupta for additional consultation or information. Morulaa HealthTech as successful regulatory consultants has delivered high level professionalism and quality towards our clients.