India is witnessing a high prevalence of blood and bone marrow diseases, such as aplastic anaemia, leukaemia, and multiple myeloma. Bone marrow cell separator is a standard laboratory medical device used to diagnose and monitor these diseases. The treatment and quality of life of the affected patients depend on proper diagnosis. Hence, stringent regulations for bone marrow cell separator in India are required. CDSCO regulations increase the accountability of medical device companies. CDSCO registration for bone marrow cell separator will assure patients and healthcare professionals of its quality and safety. This blog will provide an overview of the use of bone marrow cell separators and the CDSCO regulations.

Bone marrow cell separator as a medical device

Bone marrow cell separator is used to detect bone marrow diseases. When the stem cells in the bone marrow do not develop and function properly, it leads to bone marrow disease and blood cancer. Leukaemia, myelodysplastic syndrome, aplastic anaemia, thalassemia, and myeloproliferative disorders are some examples of bone marrow disease. Bone marrow diseases are usually caused by genetics and environmental factors. Bone marrow diseases are diagnosed using blood and bone marrow tests. To treat bone marrow diseases, the intensity and disorder type have to be determined. Bone marrow cell separator is used to analyse the intensity and severity of the disease.

Bone marrow cell separator, a standard laboratory medical device, is used to isolate target cells from blood and bone cells. Bone marrow samples are obtained by aspiration and trephine biopsy. The cell separator is used to collect target cells to determine the marrow health and number of blood cells being generated. Thus, bone marrow cell separator plays a vital role in diagnosis and monitoring of bone marrow and blood diseases.

Prevalence of bone marrow diseases in India

Aplastic anaemia, leukaemia, myelodysplastic syndromes, and multiple myeloma are some of the bone marrow diseases commonly observed in India. Lymphoma, leukaemia, and multiple myeloma are the most prevalent blood cancers. The bone marrow cell separators are used to diagnose and monitor these diseases.

Need for regulations for bone marrow cell separator

Owing to the increased prevalence of bone marrow diseases and blood cancer, demand for bone marrow cell separators in India is high. Given the vital role of bone marrow cell separators in India, stringent regulations are required to monitor their quality and efficacy. Diagnosis and treatment of bone marrow and blood diseases depend on the proper functioning of these medical devices. Inferior quality devices can lead to inaccurate treatment that can be detrimental for this critical patient group. Thus, Indian regulations for bone marrow cell separator monitor the quality of these devices entering the Indian market. The regulations are needed to ensure patient safety and protect public health. This in turn ensures that the quality and standard of the Indian healthcare sector are maintained.

CDSCO regulations for bone marrow cell separator

Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for all medical devices, cosmetics, and pharmaceuticals in India. CDSCO functions under the purview of Medical Device Rules 2017. This apex body monitors and regulates all bone marrow cell separators marketed in India. As per CDSCO regulations, CDSCO registration for bone marrow cell separators in India is mandatory. Given the impact and demand for this medical device in the Indian market, CDSCO strictly regulates its safety, quality, and efficacy. CDSCO regulations for bone marrow cell separator ensure substandard and inferior quality machines do not enter the Indian market.

CDSCO registration for bone marrow cell separators

To market your medical device in India, you will mandatorily need a CDCSO registration. CDSCO registration for bone marrow cell separators in India ensures high quality cell separators are provided to the patients. It assures healthcare professionals and patients of the efficacy and safety of the medical devices. Additionally, a CDCSO registration will give you access to the Indian medical device market. CDSCO registration for bone marrow cell separator demonstrates the commitment of medical device companies to deliver high-quality and effective products.

CDSCO definition for bone marrow cell separators

CDSCO definition: Bone marrow cell separator, a general laboratory equipment, is used to separate target cells from bone and blood.

CDSCO class for bone marrow cell separators

The CDSCO has categorised medical devices into four classes. The CDSCO classification system helps speed up and simplify the CDSCO registration process. In the ascending order of risk level, Class A, B, C, and D are the four CDSCO medical device classes. Depending on the risk level and intended use, CDSCO has classified the bone marrow cell separators as Class B.

Application process per CDSCO regulations for bone marrow cell separators

CDSCO has specified the required documents and application process for registering bone marrow cell separators in India.

• Manufacturing license: Companies seeking to obtain a manufacturing license for bone marrow cell separators in India need to apply using the Form MD-3. The company has to apply online and pay the necessary processing fee. After reviewing the application, the regulatory body will relay the approval via Form MD-5. This will permit the manufacturing company to manufacture, sell, and distribute bone marrow cell separators in India.
• Import license: Entities seeking to import these devices into India need to apply using the Form MD-14. The company has to apply online and pay the necessary processing fee. After reviewing the application, the regulatory body will relay the approval via Form MD-15. This will permit the company to import bone marrow cell separators into India.
• Loan license: A loan license can be used to manufacture medical devices when the manufacturer does not own a manufacturing facility. Manufacturers seeking to obtain a loan license for manufacturing bone marrow cell separators in India need to apply using the Form MD-4. The medical device manufacturer has to apply online and pay the necessary processing fee. After reviewing the application, the regulatory body will relay the approval via Form MD-6. This will permit the manufacturer to manufacture, sell, and distribute these devices in India with a loan license.

For registration per CDSCO regulations for bone marrow cell separator, necessary supporting documents are required. Separate sets of supporting documents will be required depending on the application form. CDSCO has provided a detailed checklist of documents that should accompany each application form. The checklist can be found here. The Pharmadocx Consultants team will be more than happy to help you prepare the necessary supporting documents.

Licensing authority

State Licensing Authority (SLA) grants licenses for all Class A and B medical devices manufactured, distributed, and sold in India. Companies seeking CDSCO registration for bone marrow cell separators to manufacture and sell their product in India need to apply to the SLA.

How can Pharmadocx Consultants help you register bone marrow cell separators in India?

Do you want to market bone marrow cell separators in India? Are you unsure of the Indian regulations for bone marrow cell separator? Fret not! We have got you covered. With over 27 years of experience and having served more than 600 clients, we have in-depth knowledge of CDSCO regulations. Let us make the arduous CDSCO registration process hassle free for you. Simply call/Whatsapp us at 9996859227 or drop an email at [email protected] and we will simplify your CDSCO registration process.