How to Obtain CDSCO Medical Device Registration for Organ Preservation Solution in India?

In India, the organ preservation market reached a value of 11.7 Million USD in 2021. IMARC Group expects the market to reach 18.5 Million USD by 2027, exhibiting a CAGR of 7.7% from 2022-27.Organ Preservation Solution is the most common cold storage solution in organ preservation. It was first introduced as a preservation solution for pancreas transplantation but has been widely used in preserving the different types of organs, such as kidneys, small bowel and liver, since the last 1980s. Based on the proposal initiated by the Ministry of consumer affairs, food & public distribution^[1], to the CLA (Central Licensing authority), CDSCO (Central Drugs Standard Control Organisation), to include many medical devices under the field of the DCGI, Organ Preservative Solution finally needs compulsory registration under the Medical Device Rules 2017 and other standard set by the BIS (Bureau of Indian Standard) Certification from time to time. Registration for Organ Preservative Solution under the above rules is compulsory under Class C of Medical Device Rules 2017. This write-up will study how to obtain CDSCO Medical Device Registration for Organ Preservation Solution in India.

Overview of Central Drugs Standard Control Organisation (CDSCO)

The Central Drugs Standard Control Organisation, also known as CDSCO, under the Directorate General of Health Services, Ministry of Health & Family Welfare, and Indian Government, is India’s National Regulatory Authority (NRA). Under the Drugs & Cosmetics Act, CDSCO has various responsibilities that include approval of Drugs to direct Clinical Trials, a quality check of imported Drugs in India, providing standards for Drugs and coordinating with the State Drugs Control Organisations for the activities by providing expert advice, training keeping in knowledge the uniformity in the implementation of the Drug & Cosmetics Act. Moreover, CDSCO and State Drugs Control Organisations are together answerable for permit of licenses of certain specialized kinds of critical drugs and medical devices.

What is Organ Preservation Solution?

Organ Preservation refers to maintaining the viability of healthy organs harvested from the donor body to transplant them into the receiver body. This procedure involves removing, storing & transporting the organ in SCS (Static Cold Storage), which prevents harmful metabolites from breaking down healthy tissues, thereby enhancing the ability to restore normal organ functionality post-transplantation. It also employs several other techniques, like hypothermic machine perfusion and NMP (Normothermic Machine Perfusion), to maintain the oxygen level & temperature of the organs. Organ preservation also utilizes special solutions important in sustaining donor organ quality.

Notified Bodies for Medical Devices in India

1. Central Licensing Authority (CLA): It is entrusted to provide a license to every imported medical device in India, including providing manufacturing, wholesale and loan license to medical devices under Class C & D. additionally, CLA might provide services of a notified body to inspect the manufacturing premises, location and technical review of medical devices under Classes C &D.
2. State Licensing Authority (SLA): It has been entrusted with the liability of providing manufacturing, wholesale, and loan license to medical devices under Class A & B. SLA also assigns a notified body to validate the QMS (Quality Management System) requirements & technical review of medical devices under Class A & B manufacturers.

Regulatory Bodies for CDSCO Medical Device Registration for Organ Preservation Solution

1. CDSCO is the head regulatory body under the Directorate General of Health Services and Ministry of Health and Family Welfare that regulates drugs and medical devices.
2. DCGI is the head of the CDSCO, and it is answerable for approving quality drugs, medical devices and cosmetics to be sold to Indian customers and regulating clinical trials.
3. The Drug & Cosmetics Act and Rules regulate the manufacture, import, distribution and sale of Drugs and medical devices in India.

Classification of Medical Devices

The Medical Devices under CDSCO have been classified into two types, as given below:

• Non-Notified Medical Devices

1. Non-notified medical devices include 313 medical items that must be CDSCO Certified.
2. According to the new amendment issued from the CDSCO, medical devices like instruments, implants and apparatus, irrespective of their usage for a distinct objective, will fall under non-notified medical devices.

• Notified Medical Devices

1. Notified medical devices comprise 37 items which need to be CDSCO certified.
2. According to Rule 4 of medical devices rule 2017, notified medical devices are those whose registration is compulsory.

Medical Devices have been classified as per Risk-Based

Risk-Based	Class	Examples of Medical Device
Low	A	Surgical dressing, Syringes, etc.
Moderate Low	B	Pregnancy Kits, Surgical Gloves, etc.
Moderate High	C	Anaesthesia, Lung Ventilators, etc.
High	D	Heart & Lung Bypass Unit, Pacemakers, Implants, etc.

Documents Required for Obtaining CDSCO Medical Device Registration for Organ Preservation Solution

Following are some essential documents to obtain CDSCO Medical Device Registration for Organ Preservation Solution:

• Form under the proforma prescribed in the Drugs & Cosmetics Rules;
• ISO 13485 Certificate;
• Legal manufacturer’s name & address along with phone no. and email id;
• C.E. Design Certificate;
• Actual Site information;
• Full Quality Assurance Certificate;
• Nature of activity (import/export)
• Undertaking that all the information provided is authentic;
• Brand Name (if registered under the Trade Marks Act, 1999);
• Certificate of Marketability from the GHTF (the European Union, the United States,

Japan, Australia, Canada)

• Free Sale Certificate (FSC) and/or Certificate by the Foreign Government;
• Device Master File;
• Plant Master File.

Procedure to Obtain CDSCO Medical Device Registration for Organ Preservation Solution

Following is the process for getting CDSCO Medical Device Registration for Organ Preservation Solution in India:

• An application form will be duly submitted online along with the necessary documents in the CDSCO Sugam portal of the Ministry of Health.
• Declaration for compliance along with quality management system will be correctly submitted.
• Documents scrutinization will be done by the L.A. (Licensing Authority).
• In case the devices are class B, the notified body will inspect them within three months of submitting the application form.
• An inspection report will be submitted to CLA/SLA, and a grant of medical device registration certificate will be provided after examining the reports.
• If the device is under classes C & D, an inspection will be conducted by authorized officials.

Time taken for CDSCO Medical Device Registration for Organ Preservation Solution

It takes almost three months to register a medical device for domestic manufacturers and 6 to 9 months for a foreign manufacturer. Unless an examination is required by the Technical Presentation or Subject Expert Committee, if these are necessary, the medical device registration process is extended to an additional 3 to 6 months.

Renewal of the CDSCO Medical Device Registration for Organ Preservation Solution

The application form for renewal of CDSCO Medical Device Registration for Organ Preservation Solution shall be made at least 9 months before the registration expiry. Since there are no additional requirements for the renewal process, it will be essential for the medical device registration certificate holder to provide a copy of the Plant Master File (PMF) & Device Master File (DMF), where there is no change in the PMF and DMF.

Conclusion

One of the main factors propelling the growth of the organ preservation market in India is the increasing number of organ failures brought on by the rising incidence of different chronic conditions, such as obesity, cardiovascular disease, and gastrointestinal disorders. The growth of the market in the nation is also being supported by the expansion of the medical industry and an increase in per capita spending on healthcare services. Additionally, the Government of India (GoI) promotes organ donation through initiatives, another element that stimulates growth.

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