Central Drug StandardsControl Organization (CDSCO) is India’s regulatory body regulating medical devices or in-vitro medical devices being marketed in the Indian market. The main aim of CDSCO is to safeguard, enhance and promote public health and safety by making sure that medical devices or in-vitro medical devices being marketed are safe, effective, and have a high benefit-risk ratio. CDSCO follows the Medical Device Rule,2017, Drugs and Cosmetics Act 1940, and Rules 1945 thus, manufacturers and importers must comply with these acts and laws if they want to sell and distribute their medical devices in the Indian market. Under CDSCO Central and State licensing authorities are responsible for monitoring the licensing application for all classes of medical and in-vitro diagnostic devices. In the year 2019, CDSCO released a notice saying if any manufacturer or importer wanted to sell Glucometer from 1st Jan 2021, it was made mandatory to have a license from Central Licensing Authority. A glucometer is a device used to measure blood glucose concentration, thus placed in the In-Vitro Diagnostic category.
What are In-Vitro Diagnostic devices?
n-Vitro Diagnostics are the substances that are intended to be used on the human and animal bodies and help in diagnosing the disease, disorders, and conditions in humans and animals, which are covered under subclause (i) of clause (b) of section 3 in Drugs and Cosmetics Act,1940 and IVDs that are notified as the device from time to time.
Classification of In-Vitro Diagnostic:
Central Licensing Authority under the Central Drugs Substances and Control Organization (CDSCO) classifies In-Vitro Diagnostics as per Chapter II, Rule 4, Sub-rule (2) of medical device rules, 2017, into four classes, namely:
Risk Class | Risk Involved |
Class A | Low risk |
Class B | Low-moderate risk |
Class C | Moderate high risk |
Class D | High Risk |
What is a Glucometer
Glucometers, also called Glucose meters, are devices used to measure the concentration of glucose in the blood. A glucometer uses somewhere between 0.5 µl to 3.0 µl blood to measure the glucose. There are two kinds of glucose meters: Standard glucose meters and Continuous glucose meters. The Glucometer belongs to class C, which means it is a moderate-risk device, as little inaccuracy in results can put patients in life-threatening situations. People who have diabetes are the intended population of this device as they need to manage their blood glucose levels to avoid any major health issues.
Glucose – Glucose is a simple sugar in our body and is used as an energy source. When a person has diabetes (when the body can’t make enough insulin), they use the Glucometer.
Forms and data required to register the Glucometer in India
FORMS | DESCRIPTION | Fees |
Form MD-7 | Application for grant of permission to import or manufacture for sale or for distribution of Glucometer in India |
INR 25,000 |
Form MD-9 | Permission to import or manufacture Glucometer | |
Form MD-14 | Application to import all classes of In-vitro diagnostic medical devices |
For import $ 3000 for each site and $ 500 for each IVD. |
Form MD-15 | Permission to import all classes of In-vitro diagnostic medical devices |
Steps to register the Glucometer in India
Step 1: Applicant needs to determine if the Glucometer falls under the category of notified In-vitro devices, which needs registration in India as per the notification of CDSCO.
Step 2: Applicant needs to classify the Glucometer in a risk-based class (Class C) because it is a moderate high-risk device.
Step 3: Applicant needs to fill out the application Form MD-7 to get permission to manufacture or Form MD-14 to import the Glucometer to market it in the Indian market.
Step 4: The importer needs to appoint the Indian authorized agent, per the MDR,2017 rules, as the manufacturer’s legal representative who will look out for all the manufacturer’s official work if the manufacturer is not from India.
STEP 5: Applicant needs to submit the following documents for the Glucometer:
To manufacture the Glucometer, the applicant needs to submit the mentioned data:
- Cover letter
- Fees
- Constitution details of the manufacturing firm or authorized agent.
- The Establishment /Site ownership /Tenancy Agreements.
- Copy of Duly notarized valid copies of Quality Certificate in respect to manufacturing site(s), if any;
- Copy of Certificate supporting quality management system (ISO: 13485), if any;
- Quality management system as per the medical device rule,2017.
- Reference for predicate device,
- Plant master file
- Device master file
- Test license (for the domestic manufacturer)
- Undertaking that the manufacturing site complies with the quality management system.
To import the Glucometer, the applicant needs to submit the mentioned data
- Cover letter
- Power of attorney
- Self-attested copy of wholesale license or manufacturing license
- Notarised copy of overseas manufacturing site,
- Free sale certificate from country of origin
- Free sale certificate from any country, namely USA, Australia, Canada, Japan, UK, and European Union countries.
- Inspection or audit report
- Notarized copy of quality assurance
- Certificates (ISO, full quality certificate, CE design certificate, Declaration of conformity)
- Plant master file (as per appendix I of MDR, 2017)
- Device master file (as per appendix II of MDR, 2017)
- Constitution details of the authorized Indian agent.
STEP6: Central licensing authority permits manufacturing or importing Glucometer through Form MD-9 or Form MD-15 if CLA is satisfied with the applicant documents.
Timeline for the Glucometer registration under CDSCO in India:
CDSCO takes six to nine months to register Glucometer to sell and distribute in the Indian market after the applicant applies. Registration is valid for five years, and if the needs to renew, the applicant must submit the renewal application six months before the import license expires.
Conclusion:As per the CDSCO notification, the Glucometer falls under the notified devices and belongs to Class C. Thus, manufacturers or importers must register the Glucometer as per the guidelines if they want to sell and distribute it in the Indian market. CDSCO is taking steps to ensure that the Glucometer marketed is safe and effective to use by the diabetic population of India since it helps them manage their disease or condition.
Download Checklist of Documents Required for Registration of Medical Devices with CDSCO
These comprehensive set of checklists are designed to help streamline the registration process and ensure that you have all the necessary documentation in place.
