The Dialysis or Haemodialysis machine comprises a series of osmosis membranes that act as microscopic filters and a special liquid called dialysate. The osmosis membranes filter waste items from your blood based on its molecular size, passing them into the dialysate fluid. Dialysis is a treatment for persons with failing or injured kidneys. When your kidney is unable to filter blood thoroughly, due to which toxic wastes water enters your blood stream and leads to a probable renal failure. Dialysis is a process which works instead of your kidneys and does their job by eliminating waste materials and extra fluid from your blood which would otherwise be very toxic for your body. 1st April 2021 onwards, CDSCO (Central Drugs Standards Control Organisation), the government agency under the Ministry of Health & Family Welfare, has issued an order to regulate Dialysis machines, all implantable devices & MRI machines. Medical equipment like implantable equipment, PET scanners, defibrillators, X-ray machines and cell separators used in dialysis will require a Manufacturing or importing license by either the Central Licensing Authority or a State Licensing Authority to enter the country. We will be discussing CDSCO Medical Devices Registration for Dialysis Machine in this blog.
Medical Equipment Classification under CDSCO
The absolute risk analysis of a medical device depends on how it is meant to be used and its intended function or purpose; nonetheless, medical equipment is typically categorized based on the dangers it poses to its patient. Medical devices are divided into four groups based on their application and risk. The new regulations govern devices per a risk-based methodology. The degree of regulation a gadget receives is influenced by its intended purpose and technological characteristics. The new classification system assigns devices to one of four classes—A, B, C, or D—with Class A posing the lowest risk to patients and Class D posing the highest risk.
Risk Based Classifications for Medical Equipment & Devices under CDSCO
Medical Equipment & Devices under CDSCO are generally based on the risks, medical device’s intended purpose and use, and accurate risk-based analysis. The medical equipment & devices under the CDSCO Classification have a large group of devices, like cannulas and stents, in specific subgroups.
|Risk||Examples of Medical Devices|
|Low Risk (Class A)||Syringes, Surgical dressings, etc.|
|Low Moderate Risk (Class B)||Pregnancy Kits, Surgical gloves, etc.|
|Moderate High-Risk (Class C)||Anaesthesia, Lung Ventilators, etc.|
|High Risk (Class D)||Implants, Pacemakers, Heart & Lung Bypass Unit, etc.|
Documents required for the CDSCO Medical Devices Registration for Dialysis Machine
Following are some vital documents required for obtaining CDSCO Medical Devices Registration for Dialysis Machine:
- Form 40 per the proforma prescribed in the Drugs & Cosmetics Rules,
- ISO 13485 Certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Undertaking that all details provided is authentic
- Either a Free Sale Certificate or Certificate from the Foreign Government
- Certificate of Marketability from GHTF (Canada, Australia, Japan, the European Union, & the United States);
- Plant Master Report
- Device Master File
Process for Obtaining CDSCO Medical Devices Registration for Dialysis Machine
The CDSCO Medical Devices Registration is a completely online process. Following are the procedures for getting CDSCO Medical Devices Registration for Dialysis Machine by the online CDSCO Portal:
Step 1: The applicant must have to visit the CDSCO Registration Portal.
Step 2: The applicant must apply for registration; for that, an applicant must go to the registration purpose page and click on submit.
Step 3: Once the applicant opens the registration page, an applicant needs to fill in all the essential details as provided in the application form.
Step 4: Fill out the Registered Indian Address Form containing information.
Step 5: Once the applicant submits the application form correctly, an applicant will get a confirmation link to the applicant’s registered email id to verify the registration. Then the applicant needs to click on the link to activate the applicant account on the CDSCO Portal.
Step 6: Once the confirmation link is clicked, the application form for CDSCO Registration will be submitted to the authorized authority for approval.
Step 7: Once the application form for CDSCO Registration is approved, an approved email will send to the applicant’s registered email id. In case the application is rejected, an email for rejection will be sent to the applicant’s email id. Once the applicant gets the approval mail, CDSCO Registration will be completed.
Validity and Time Involved in Registration
If the DGCI does not ask for Technical Presentation or SEC (Subject Expert Committee) inspection, it will take time of 6 to 9 months to get a CDSCO Registration. If there is a Technical Presentation or SEC (Subject Expert Committee) inspection, it requires an additional 3 to 6 months.
The CDSCO Medical Devices Registration for Dialysis Machine is valid for 3 years from the date of issue of registration unless suspended or cancelled by the DGCI authority for proper reasons.
Renewal of the CDSCO Medical Devices Registration for Dialysis Machine
The application for renewal of the CDSCO Medical Devices Registration for Dialysis Machine shall be made at least 9 months from the expiry of the CDSCO Registration Certificate. Though there are no additional requirements for the renewal of the registration certificate, it shall be essential for the registration certificate holder to provide a copy of the PMF (Plant Master File) and DMF (Device Master File), where there are no changes in the PMF & DMF.
Post-Compliance after Receiving CDSCO Registration Certificate
Following are the post-compliance after getting CDSCO Registration Certificate:
- If any change has taken place regarding the constitution of the firm or address of the registered office or factory, the Medical devices manufacturer or authorized representative of the importers to intimate the licensing department regarding the same in writing;
- If any such change has occurred, the existing CDSCO Registration Certificate shall be valid for 3 months from the date that change has occurred. During this time, the manufacturer or authorized representative of the importer shall be required to obtain a new CDSCO Registration Certificate.
The medical sector expects two key developments in 2021: whether it will be better to submit separate laws to govern medical equipment under CDSCO and whether the CDSCO will issue the necessary licences for the import of medical equipment promptly.