On April 18, 2021, the Central Drugs Standard Control Organization (CDSCO) issued an order regulating Bone marrow cell separator equipment, all implanted devices, MRI equipment, and other medical devices as drugs, effective as of April 1, 2021. According to Order No. S.O. 775(E), dated February 8, 2019, the importer or manufacturer of such devices must obtain an import or manufacturing licence from the Central Licensing Authority. These devices include all implantable medical devices such as C.T. scan equipment, MRI equipment, Defibrillators, PET equipment, Dialysis machines, X-ray machines, and bone marrow cell separators. As a result, if a current importer or manufacturer of one of the devices mentioned earlier applies for a licence under the MDR of 2017, the application will be accepted, and the importer or manufacturer may continue to import or manufacture such devices. This write-up will discuss CDSCO Medical Device Registration for Bone Marrow Cell Separator.
Brief of Drugs & Cosmetics Act, 1940
The Drugs & Cosmetics Act of 1940 is an Act introduced by the Parliament of India that regulates the manufacture, import, or distribution of drugs in the country. The Act’s primary goal is to ensure that drugs & cosmetics sold in India are effective, safe and meet quality standards. The associated Drugs & Cosmetics Rules, 1945, provide provisions for categorizing drugs into schedules and guidelines for storing, displaying, selling, and prescribing all categories.
What is a Bone Marrow Cell Separator?
In the case of diseases such as bone marrow disease or leukaemia, the bone marrow makes abnormal white blood cells. A bone marrow cell separator is required to detect the disease or its intensity,. It is a general laboratory medical device to isolate target cells and cells concentrated through bone & blood. Bone marrow samples can be obtained through aspiration & trephine biopsy. It is listed under the Class B medical device category depending on the risk type.
Regulatory Bodies for the CDSCO Medical Device Registration in India
- CDSCO (Central Drugs Standards Control Organization): It is the head regulatory body in India, under the DGHS (Directorate General of Health Services) and Ministry of Health & Family Welfare, which regulates pharmaceuticals & medical devices.
- The Drugs & Cosmetic Act and Rules: These rules regulate the Manufacture, Import, and Distribution of Drugs in India.
- DCGI: It’s the head of CDSCO and is answerable for the approval of quality drugs & cosmetics to be sold in India and for regulating clinical trials.
Classification of Medical Devices
Medical devices under CDSCO have been classified into two categories, as mentioned below:
- Notified Medical Devices
- According to Rule 4 of Medical Devices Rule 2017, notified medical devices are those whose certification is compulsory.
- Notified medical devices comprise a total of 37 items which compulsory need to be CDSCO Certified.
- Non–Notified Medical Devices
- According to the new amendment issued through CDSCO, devices like instruments, implants and apparatus, irrespective of their usage for the distinct objective, will fall under non-notified medical devices.
- Non – Notified medical devices include 313 products, which must be CDSCO Certified.
Risk Based Classifications for Medical Devices & Equipment under CDSCO
Medical Devices & Equipment under CDSCO are generally based on the risk, medical devices’ intended objective and use, and accurate risk-based analysis. The medical devices & equipment under the CDSCO Classification have a large group of devices, such as cannulas & stents, in specific subgroups;
|Risk Category||Examples of Medical Devices|
|Low (Class A)||Surgical dressings, Syringes, etc.|
|Low Moderate (Class B)||Surgical gloves, pregnancy Kits, etc.|
|Moderate-High (Class C)||Lung Ventilators, Anaesthesia, etc.|
|High (Class D)||Heart & Lung Bypass Unit, Pacemakers, Implants, etc|
Documents Required for CDSCO Medical Device Registration for Bone Marrow Cell Separator
Following are some essential documents required for getting CDSCO Medical Device Registration for Bone Marrow Cell Separator:
- Form 40 under the proforma prescribed in the Drugs & Cosmetics Rules;
- ISO 24651: 2022 Certificate;
- Legal manufacturer’s name & address with phone no. email id;
- C.E. Design Certificate;
- Actual Site Information;
- Full Quality Assurance Certificate;
- Nature of activity (import or export)
- Undertaking that all the information provided is authentic;
- Band Name (if registered under the Trade Marks Act, 1999);
- Certificate of Marketability from GHTF (the United States, the European Union, Japan, Australia, Canada)
- Free Sale Certificate (FSC) or Certificate from the Foreign Government;
- Device Master File;
- Plant Master Report.
Procedure to Obtain CDSCO Medical Device Registration for Bone Marrow Cell Separator
The CDSCO Registration is an entirely online process. Following is the process for obtaining CDSCO Medical Device Registration for Bone Marrow Cell Separator:
Step 1: The applicant has to visit the CDSCO (Sugam Portal);
Step 2: The applicant needs to apply for CDSCO Registration; for that, the applicant needs to go to the CDSCO Registration purpose page and click on submit.
Step 3: After the applicant opens the CDSCO Registration page, the applicant must fill in all the vital information provided in the application form.
Step 4: Fill out the Registered Indian Address Form containing details.
Step 5: After the applicant submits the application form correctly, the applicant will get a confirmation link to their registered email id to verify the Medical Device Registration. Then the applicant must click on the link to activate the applicant account on the CDSCO Sugam Portal.
Step 6: After the confirmation link is clicked, the application form for Registration will be submitted to the authorized department for approval.
Step 7: After the application form for Registration is approved, an approved email will send to the applicant’s registered email id. If the application form is rejected, an email for rejection will be sent to the applicant’s email id. After the applicant gets the approval email, CDSCO Medical Device Registration will be completed.
Note: After getting the CDSCO Registration Certificate, it shall be valid for three years from the date of issue of the Registration Certificate unless cancelled or suspended by the DGCI authority.
Time Taken for CDSCO Medical Device Registration for Bone Marrow Cell Separator
It takes almost 6 to 9 months to register a medical device. Unless there’s an examination required through Technical Presentation or Subject Expert Committee (SEC), if these are necessary, then the registration process is extended by an additional 3 to 6 months.
Renewal of the CDSCO Medical Device Registration for Bone Marrow Cell Separator
The application for renewal of the Medical Device Registration certificate shall be made at least 9 months before the expiry of the Registration. Though there are no additional requirements for the renewal process, it shall be essential for the Registration Certificate holder to provide a copy of the DMF (Device Master File) and PMF (Plant Master File), where there is no change in the DMF and PMF.
India’s medical device market is anticipated to grow over the coming years due to rising health awareness, the middle class, and government health initiatives. The Indian government published the Medical Device Rules in 2017 to alter how medical devices are governed. The CDSCO (Central Drugs Standard Control Organization), a Ministry of Health and Family Welfare division, ensures that machines abide by the regulations, which came into force in January 2018.
Read our Article:An Overview of CDSCO Registration Certificate for CT Scan Machine