The Central Drugs Standard Control Organization (CDSCO) oversees the registration of IVD in India. The number of IVD devices requiring complete technical documentation supporting their registration applications was significantly expanded by the new Medical Device Rules, 2017. Formerly, only the critical IVD devices needed registration, along with a complete device master file, before being placed on the market in India. Under the new Medical Device Rules, a risk-based classification based on the risk is given for IVD devices, and prior to importation, all test kits must obtain Form MD 15. Registration Of IVD In India is made by following.

Required elements of the registration application include:

1. Proof of reference country approval

2. ISO 13485 certification of the manufacturing facility

3. Full technical details based on the prescribed requirements of the device master file

Further, performance evaluation reports obtained from the National Institute of Biologicals (NIB) are needed for IVD devices and test kits related to:

• HIV
• HBV
• Blood Grouping Reagent
• Blood Glucose Test Reagent
• Cancer
• Tuberculosis
• Malaria
• Dengue
• Chikungunya
• Syphilis
• Typhoid
• Influenza
• TORCH (Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus)
• Chlamydia
• Pneumonia
• Methicillin-Resistant Staphylococcus Aureus
• Entero Virus
• Marker for congenital disorder, e.g. Screen test for Down Syndrome
• Sexually transmitted agentie. Treponema pallidum. Neisseria gonorrhoeae, Herpes Virus, Human Papilloma Virus, 
• Other life-threatening infections/agents

For Testing and Calibration Laboratories (NABL), accredited laboratory performance evaluation reports must be conducted by a local National Accreditation Board.

IVD Classification In India 

In-vitro diagnostics are categorized based on the risk level and fall into 1 of 5 categories: Class A (Non-Measuring/Sterile), Class A (Measuring/Sterile), Class B, Class C, or Class D. The CDSCO issues the latest IVD classification guidance.

Essential Licenses For Commercialization Of IVDs In India

1. Test License in Form 11

2. Performance Evaluation Report

3. Registration Certificate in Form 41

Test License in Form 11

The test License in Form 11 is used to import small quantities of drugs / Medical Devices/ Diagnostic kits for examination purposes, tests, or analyses given that under Form 11, Imported IVDs should not be used for any commercial purpose.

A Test License is suspended or canceled sooner and shall be valid for 1 year from the date of license issue.

Document Requirements for Registration Of IVD In India 

• for the proposed quantity of each of the product Utilization breakup along with Justification 
• Product Inserts, the proposed product label
• The proposed product testing protocol of 
• A valid copy of the manufacturing license/wholesale license(if any)
• An undertaking stating that the proposed kits are not used for Commercial Purposes 
• Valid Copy of the NABL accreditation certificate of testing laboratory(wherever applicable)

Performance Evaluation Report

An applicant must submit a performance evaluation report for three lots of Notified IVD kits/reagents during the application for a registration certificate.

The report of Performance Evaluation should mention the following details: Product name, lot / Batch number, manufacturer name, importer name, import / Test licenses number, number of samples tested, testing principle (ELISA/Rapid/NAAT, etc.), information about reference used, Testing procedure, Specificity, Sensitivity, Positive predictive value, Negative predictive value, Report number, Date of analysis, designation & Signature of analyst and, authorized signatory of the laboratory etc.

Registration Certificate In Form 41

Registration Certificate in Form 41 and Import License in Form 10 are required to import Notified IVD kits/reagents in India. If the application is complete in all respects and information mentioned in Schedules D-1 and D-II is in order, the authority of licensing shall, within nine months from the date of an application receipt, issue such Registration Certificate through Form 41. For each category, test strip applicants must submit a separate fee,  midstream, cassettes, etc., which the firm intends to import/Register.

A Registration Certificate is cancelled or suspended sooner and shall be valid for three years from the license issue date.

Also check this:-

• Procedure to Obtain Manufacturing License for IVD

Key document Requirements for Registration Of IVD In India 

• Form 40
• TR6 Challan
• Power of Attorney
• Wholesale Drug License
• Schedule DI
• Schedule DII
• Information as per the Annexure B(HIV, HCV, HBV & Blood Grouping Sera) of Schedule DII
• Quality Management System Certificate (ISO 13485)
• Total Quality Assurance Certificate/ CE Type Examination Certificate/CE Production Quality Assurance Certificate/
• CE Product Quality Assurance
• CE Design Certificate (if applicable)
• Declaration of Conformity
• FSC viz USA, EU, Canada, Japan, Australia
• Plant Master File
• Device Master File
• Products performance Evaluation Report (HIV, HCV, HBV, & Blood grouping sera) from NIB, Noida, for three consecutive batches.
• PMS Study Report
• AES/SAEs/Death/Recall/complaints detail of the proposed products reported globally along with a protocol for the investigation of root cause and CAPA taken by the manufacturer (if any)
• The National Control Authority (NCA) of the country of origin conducted the detailed evaluation report concerning the proposed kit (s) of 3 consecutive batches. If the Evaluation report from NCA is unavailable, then the Evaluation / Batch release report from the authorized Notified body may also be accepted.
• Product inserts
• Original labels and pack sizes

An authorized agent/regulatory Consultant in India will be able to compile and obtain the above-specified licenses on behalf of the manufacturer (test license, performance evaluation report, and registration certificate).

Why choose ELT Corporate Registration Of IVD?

Lots of requirements and paperwork are needed for Registration Of IVD in India. Applicants can face difficulty fulfilling such requirements and paperwork. In such cases, choosing an ELT corporate is highly recommended. Because it is good regulatory service company in India, Always available whenever contacted and provides help in all the stages of Registration Of IVD in India.

Conclusion

The Registration Of IVD in India is crucial to complying with the requirements of the Medical Device Rule of 2017. This process includes submitting the documents and following the steps mentioned above.