Introduction
In-Vitro Diagnostic (IVD) kits/reagents are regulated in India under the regulatory provisions of the Drugs & Cosmetic Act 1940 & Rules 1945. In-Vitro Diagnostic Products are those substances that are intended to be used for or in the use in diagnosis of disease or disorders in human being or animals. IVD s are considered as Drugs in the Indian regulatory framework” as defined under sub-clause (i) of clause (b) of Section 3 of Drugs and Cosmetic Act 1940. The diagnostic kits and reagents have been classified as Notified and Non-Notified. The current Indian regulation also has a list of 22 notified medical devices under the Indian central regulatory body CDSCO (Central Drugs Standard Control Organization)
Following IVD kits/reagents are Notified under 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 kits and Reagents excluding those listed under Notified category would be covered under the category of Non-Notified IVD products.
Key Licenses for Commercialization of IVD s in India
- Test License in Form 11
- Performance Evaluation Report
- Registration Certificate in Form 41
1. Test License in Form 11
The Test License in Form 11 is to import small quantities of drugs / Medical Devices/ Diagnostic kits, for the purpose of examination, test or analysis provided that Imported IVD s under Form 11 should not be used for any commercial purpose.
A Test License unless, it is sooner suspended or cancelled, shall be valid for a period of one year from the date of its issue.
Document Requirements:
- Utilization breakup along with Justification for the proposed quantity of each of the product
- Product Inserts, Label of the proposed product
- Testing protocol of the proposed product
- Valid copy of manufacturing license/wholesale license(if any)
- Undertaking stating that the proposed kits are Not For Commercial Purpose
- Valid Copy of NABL accreditation certificate of testing laboratory(wherever applicable
2. Performance Evaluation Report
An applicant is required to submit performance evaluation report for 3 lots of Notified IVD kits/reagents during the submission of application for registration certificate.
Performance Evaluation Report should mention 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.
3. Registration Certificate in Form 41
For the import of Notified IVD kits/reagents in India, Registration Certificate in Form 41 and Import License in Form 10 are required. If the application is complete in all respects and information specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41. Applicant is required to submit separate fee for each categories like test strip, cassettes, midstream, etc which the firm intent to import/Register.
A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.
Key document Requirements:
- Form 40
- TR6 Challan
- Power of Attorney
- Whole Sale Drug License
- Schedule DI
- Schedule DII
- Information as per Annexure B(HIV, HCV, HBV & Blood Grouping Sera) of Schedule DII
- Quality Management System Certificate (ISO 13485)
- Full Quality Assurance Certificate /CE Production Quality Assurance Certificate/ CE Type Examination 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
- Performance Evaluation Report of Products (HIV, HCV, HBV & Blood grouping sera) from NIB, Noida for three consecutive batches.
- PMS Study Report
- Detail of AEs/SAEs/Death/Recall/complaints of the proposed products reported globally along with protocol for investigation of root cause and CAPA taken by the manufacturer (if any)
- The report of evaluation in details conducted by the National Control Authority (NCA) of Country of origin in respect of Proposed Kit(s) of three Consecutive batches. If the Evaluation report from NCA is not available then Evaluation / Batch release report from the authorized Notified body may also be accepted.
- Product inserts
- Original labels and pack sizes
An Authorized Indian Agent / Regulatory Consultants will be able to compile and obtain the above mentioned licenses (Test License, Performance Evaluation Report and Registration Certificate) on behalf of the manufacturer.
