In India, In-Vitro Diagnostic (IVD) kits are regulated under the Drugs and Cosmetics Act 1940 & Rules 1945. In-Vitro Diagnostic products are those intended for or in use in diagnosing disorders, diseases and infections in human beings or animals. IVDs are considered as “Drugs” in the Indian regulatory framework as defined under Section 3 (b) (i) of the Drugs & Cosmetic Act 1940. The diagnostic kits/reagents have been classified as non-notified and notified. The present Indian regulation also has a list of 22 notified medical devices under the Central Drugs Standard Control Organization (CDSCO). This blog will discuss CDSCO Medical Device Registration for IVD Lab Kits.
Following IVD Lab kits are notified under the Drugs and Cosmetic Act 1940:
- In-Vitro Diagnostic Devices for HIV
- In-Vitro Diagnostic Devices for HBV
- In-Vitro Diagnostic Devices for HCV
- In-Vitro Blood grouping sera
All In-Vitro Diagnostic Lab kits, excluding those listed under Notified category, would be covered under Non-Notified IVD products.
What are IVD Lab Kits?
In-Vitro Diagnostics (IVDs) are tests that can identify diseases, disorders, and infections. In vitro, which means “in glass,” means these tests are frequently carried out in test tubes & other similar apparatus or tools as opposed to in vivo testing, which are carried out inside the body. In-Vitro tests may be done in labs, hospitals, or even individuals’ homes. The tests themselves can be performed on a variety of instruments ranging from small, handheld tests to complex lab instruments. They enable medical professionals to diagnose patients accurately and pursue the most effective treatments. This is especially true in primary healthcare settings in low-income and middle-income nations. A wide range of IVDs is accessible for patient testing in the primary care setting where laboratories are unavailable, which frequently lack an integrated network of laboratories for such diagnoses.
Important Regulatory Bodies for CDSCO Medical Device Registration for IVD Lab Kits in India
- The Drugs & Cosmetic Act & Rules: These rules regulate the manufacture, import, and distribution of Drugs & medical devices in India.
- CDSCO is the regulatory body in India, under the Directorate General of Health Services (DGHS) and Ministry of Health & Family Welfare which regulates medical devices and drugs.
- DCGI is the head of the CDSCO and is liable for approving quality drugs, cosmetics, and medical devices sold in India and regulating clinical trials.
Risk-Based Classifications for Medical Devices
The medical devices have been classified into various categories depending on risk-based:
- Class A: Low
- Class B: Moderate Low
- Class C: Moderate-High
- Class D: High
Required Documents for Getting CDSCO Medical Device Registration for IVD Lab Kits
Following are the vital Documents required in obtaining CDSCO Medical Device Registration for IVD Lab Kits:
- Power of Attorney;
- Schedule DI;
- Schedule DII;
- Details according to Annexure B (HIV, HBV, HCV, and Blood Grouping Sara) of Schedule DII;
- TR6 Challan;
- Whole Sale Drug License;
- Quality management system certificate (ISO 13485);
- CE Design Certificate (if applicable);
- Complete Quality Assurance Certificate or CE Production Quality Assurance Certificate or CE Type Examination Certificate or CE Product Quality Assurance;
- Declaration of Company;
- Plant Master File;
- FSC viz USA, EU, Japan, Canada, Australia;
- Device Master File;
- PMS Study Report;
- Performance Evaluation Report of Products;
- PMS Study Report;
- The evaluation report is information conducted by the National Control Authority (NCA) of the Country of origin in respect of three consecutive batches of proposed kits. In case the evaluation report from NCA is not available, then an evaluation or batch release report from the authorised notified body may also be accepted;
- Information of AEs/SAEs/Recall/Death/Complaints of the proposed products reported globally and protocol for the investigation of root cause & CAPA taken by the manufacturer (if any);
- Original labels and pack sizes;
- Product inserts.
Procedure to Get CDSCO Medical Device Registration for IVD Lab Kits
The CDSCO Medical Device Registration for IVD Lab Kits is an entirely online process. Following are the steps for obtaining CDSCO Registration under the online portal of CDSCO:
Step 1: First, the applicant has to visit the CDSCO Registration portal.
Step 2: To apply for registration, the applicant must go to the Registration page.
Step 3: Once the applicant opens the Application Registration page, fill out all the vital details provided in the application.
Step 4: Fill out the Registered Indian Address Form containing information or details.
Step 5: Once the applicant applies correctly, an applicant will get a confirmation link to the applicant’s registered email id to verify the CDSCO Medical Device Registration. Then, the applicant must click on the link to activate the applicant account on the online CDSCO Sugam portal.
Step 6: After clicking the confirmation link, the CDSCO Registration application will be sent to the concerned authority for approval.
Step 7: Once the CDSCO Medical Device Registration application is approved, an approval email will be sent to the applicant’s registered email id. If the application is not approved, an email for rejection will be sent to an applicant’s email id. Once the applicant gets the approval mail, the applicant’s CDSCO Medical Device Registration will be completed.
Note: Registering a medical device takes around 6 to 9 months. Unless an examination is required through the Subject Expert Committee/Technical Presentation, the registration process is extended by 3 to 6 months if these are important.
Renewal Process of the CDSCO Medical Device Registration for IVD Lab Kits
The application for renewal of CDSCO medical device registration shall be made at least nine months before the expiry of the CDSCO medical device registration. There are no additional requirements for the registration renewal process. It will be essential for the certificate holder to provide a copy of the Plant Master File (PMF) and Device Master File (DMF), where there is no change in the DMF and PMF.
CDSCO is constantly working to improve its services trenchancy, safety, accountability, and regularity to guarantee the promptness, potency, and quality of the medical device products produced, imported and distributed in India. In conclusion, it is suitable to conclude that CDSCO Medical Device Registration provides the public interest priority.
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