DIAGNOSTIC KIT

REGULATORY SERVICES

NKG team has a cumulative experience of more than 50 Years in Regulatory affairs. Over years, our experts have been Behind approvals of breakthrough In Vitro Diagnostic (IVD) Kits & Technologies by helping companies from India and the World with a clear Regulatory Pathway for Successful Launch of their products under Medical Device Rules in India.

In India, import, manufacturing, sale and distribution of In Vitro Diagnostic (IVD) Medical Devices / Reagents are regulated under the provisions of Medical Device Rules 2017.

In-Vitro Diagnostic (IVDs) are defined as substances intended to be used outside used human or animal bodies for the diagnosis of disease or disorders in human beings or animals. IVDs are considered as “Drugs” as defined under sub-clause (i) of clause (b) of Section 3 of Drugs and Cosmetic Act 1940 and In Vitro Diagnostic Kits that are notified, from time to time, as a device under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.

There was a time when the concept of medical devices and diagnostics was very little in use in India. Besides, whatever equipment or systems were available, there was no control over the quality aspect and the patients at large had to suffer either because of quality or due to non availability of quality devices to treat various illness. The above difficulties were viewed seriously by the Ministry of Health and Family Welfare, Government of India and it was felt necessary to promulgate a law which would regulate the Diagnostic Kits & Medical devices including the intravenous diagnostic medical devices so that all Indian manufacturers and foreign suppliers can come under the Purview of the Guidelines of the said regulations issued by Central Drugs Standard Control Organisation.

Accordingly, in 2006 Government issued a law through which all types of diagnostic kits and medical devices felt necessary at that time were regulated.A provision was also kept to bring in any other advanced technology Devices and Diagnostics under the government Purview. This definitely helped the country to a large extent to get quality products. The government has been including more and more diagnostic kits under regulation which has helped direct control on the quality products by manufacturers and exporters to India. Over the years it has been felt by the Government that prices of a lot of kits  have been going up drastically and sometimes unaffordable to the population at large and the National Pharmaceutical Pricing authority also intervened and regulated the Prices of the Devices.

This expansion of regulations to cover all diagnostic kits has now made it mandatory for registration of devices being sold in the country. The government has also given sufficient time to the Indian Manufacturers as well as Overseas suppliers to adopt such regulations and ensure that the Indian Consumers are assured safe and quality healthcare products.

2017

YEAR

The Medical Device Rules, 2017 regulate quality of in-vitro diagnostic kits and notified medical equipment.

4

CLASSES

Class A – Low Risk,
Class B – Low Moderate Risk,
Class C – Moderate
Class D – High risk

 RISK BASED CLASSIFICATION

Under the control of Ministry of Health & Family Welfare, The Central Licensing Authority i.e. CDSCO revamped the entire regulatory framework governing import, manufacturing, sale and distribution of existing IVD Kits, Reagents & Medical Devices under the Drugs & Cosmetics Act 1945 & Rules 1940 as well as Medical Device Rules 2017 and various further notifications in these rules have come from time to time.

The rules came into force in January 2018 and the import, manufacturing, sale and distribution of existing In Vitro Diagnostic (IVD) kits/ reagents are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare under the regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945.

In line with risk based classification of Global Harmonization task Force (GHTF), under the Medical Devices Rules 2017, IN-VITRO DIAGNOSTIC KITS  in India are classified into Class A, B, C and D with the risk associated with a device increasing from Class A (Low Risk) to Class D(High Risk).

THE CLASSIFICATION IS BEING GOVERNED BY THE REASONING OF THE INTENDED USE OF RESPECTIVE IVDS.

Under Chapter II , Rule 4, Sub rule (2) of Medical Device Rules 2017 and on the basis of parameters notified in Part II of First Schedule of the Medical Device Rules 2017, IVD kits are classified as belowThe Notified IVD Kits are classified basis on the intended use or purpose of the respective IVDs. If an IVD is meant to be used in combination with another IVD, in such a case, the classification rules will be applied independently and separately to each respective IVD in the combination. Accessories are classified in their own right separately from the IVD with which they are used.

THE TYPES OF IVDS NOTIFIED UNDER THE MEDICAL DEVICE RULES 2017 ARE:
    1. In vitro Diagnostics Devices for HIV, HBV and HCV.
    2. In vitro Diagnostics Devices for HIV, HBV and HCV (Bulk)
    3. In vitro Blood Grouping Sera
    4. In vitro Blood Grouping Sera (Bulk)
WHO REGULATES WHAT

CDSCO & SLA

CDSCO

CDSCO under the Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India  is the Central Licensing Authority or the National Regulatory Authority for IVD Kits falling under Class C & Class D in case of medical Devices manufactured in India. In case of imported IVD Kits, All classes from A to D are regulated by CDSCO.

SLA

IVD Kits in Class A & B Manufactured in India are regulated by State Licensing Authorities (SLA)  (State Drug Controller) across all States/UT of India respectively. SLA is the competent authority for all enforcement, licensing and grant of permissions regarding sale, manufacture, stock of  IVD Kits falling under Class A & Class B.

Under the Medical Device Rules 2017, clear and exhaustive details are provided for Notified product categories and class, associated government fee, the notified regulatory authority in charge of regulations various aspects as well as details on types of forms and permissions that can be sought from the regulator. The below table gives a clear understanding of these all important checkpoints.

#
APPLICATION FORM
APPROVAL FORM
RISK CLASS
FEES
CDSCO
SLA
1 MD 1 – Application for grant of Certificate of Registration of a Notified Body MD 2 – Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017 NA Rs.25000/-
2 MD 3 – Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device MD 5 – Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device. A & B Rs.5000 for plant registration
Rs.500 for product (per product)
3 MD 4 –  Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device MD 6 – Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device A & B Rs.5000 for plant registration
Rs.500 for product (per product)
4 MD 7 – Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D MD 9 – Licence to Manufacture for Sale or for Distribution of Class C or Class D C & D Rs.50000 for plant registration
Rs.1000 for product (per product)
5 MD 8 – Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D MD 10 – Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device C & D Rs.50000 for plant registration
Rs.1000 for product (per product)
6 MD 11 – Form in which the Audit or Inspection Book shall be maintained   NA $6000
7 MD 12 – Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training MD 13 – Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training A,B,C,D Rs.500/-
8 MD 14 – Application for issue of import licence to import medical device In Class A  (Other than in vitro) MD 15 – Licence to Import Medical Device In Class A (other than in vitro)     A $1000 for plant
$50
 for product (per product)
9 MD 14 – Application for issue of import licence to import medical device In Class B  (Other than in vitro) MD 15 – Licence to Import Medical Device In Class B (other than in vitro) B $2000 for plant
$1000 for product (per product)
10 MD 14 – Application for issue of import licence to import medical device In Class C or D  (Other than in vitro) MD 15 – Licence to Import Medical Device In Class C or D (other than in vitro) C & D $3000 for plant
$1500 for product (per product)
11 MD 14 – Application for issue of import licence to import medical device In Class A or B  (In vitro) MD 15 – Licence to Import Medical Device In Class A or B (In vitro) A & B $1000 for plant
$10 for product (per product)
12 MD 14 – Application for issue of import licence to import medical device In Class C or D  (In vitro) MD 15- Licence to Import Medical Device In Class C or D (In vitro) C & D $3000 for plant
$500
 for product (per product)
13 MD 16 – Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training MD 17 – Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training A,B,C,D $100
14 MD 18 – Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients MD 19 – Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients A,B,C,D Rs.500/-
15 MD 20 – Application for permission to import small quantity of medical devices for personal use MD 21 – Permission to import of small quantity of medical devices for personal use A,B,C,D No fee 
16 MD 22 – Application for Grant of permission to conduct clinical investigation of an investigational medical device Form 23 – Permission to conduct Clinical Investigation A,B,C,D Rs.100000/-
17 MD 24 – Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device MD 25 – Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device A,B,C,D Rs.25000/-
18 MD 26 – Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device MD 27 – Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device A,B,C,D Rs.50000/-
19 MD 28 – Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device MD 29 – Permission to Import or Manufacture New In Vitro Diagnostic Medical Device A,B,C,D Rs.25000/-
20 MD 39 – Application for grant of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer MD 40 – Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device on behalf of manufacturer NA Rs.20000/-

New Medical Devices Rules 2017 and regulations cover Import of In vitro diagnostic kits or IVD Kits  through. SUGAM ,an online platform, Made by Central Drugs Standard Control Organisation wherein applications for the same can be submitted and permissions granted.

Importers who wish to import IVD Kits classified under any risk class i.e. Class A , Class  B Class C or Class D need to submit respective Online applications on SUGAM Portal of CDSCO which is the Central Licensing Authority for such products.

At NKG, we have been working very closely with the various stakeholders in industry as well as the government. We follow clear, transparent , complete and efficient execution of regulatory filings in order to ensure the regulatory goals of our clients are met.

 

AUTHORIZED AGENT/REGISTRATION HOLDING SERVICES

In India, An Overseas Manufacturer cannot submit an application for registration as applicants. Appointing an Indian Entity as authorised agent or license holder is mandatory in order to submit an application for registration of imported IVD Kits.

NKG holds a valid stock and sale license (Form 20B and 21B) to assist foreign manufacturers to import their IVD kits in India in less time and without any hassle.

NKG understands the needs of global brand owners and offers bespoke services to such Brand Owners or manufacturers. NKG can be nominated by overseas companies to act as its Authorised Agent in India.

SERVICES FOR GRANT OF PERMISSION FOR IMPORT LICENSE (FORM MD-14, FORM MD-15)

Diagnostic Kits or IVD Kits  which are imported in India need to be registered under the Medical Device Rules 2017. An application for Import License in MD 14 needs to be submitted to CDSCO by an authorised agent who has been appointed by a Power of Attorney.

The Appointed  agent must have a license for stock and sale in Form 20 B & 21 B for sale and distribution issued under Medical Device Rules  2017, before applying for an application for import license on behalf of the overseas manufacturer.

NKG experts help to understand the categorisation so that we can ascertain the correct fee structure applicable for the grant of approval.

 

SERVICES FOR GRANT OF PERMISSION FOR TEST LICENSE TO IMPORT IVD KITS (FORM MD-16, FORM MD-17)

In case an Importer or manufacturer of an IVD KIT intends to import small quantities of an IVD KIT for the purpose of training or demonstration or clinical investigations or for the purpose of testing , an application in Form MD 16 for Test License to import such products can be submitted to CDSCO under the new Medical Device Rules 2017.

The technical team at NKG ABC guides applicants through this process and will help them in obtaining the respective test license for the import of such IVD Kits for the above mentioned purposes.

 

 

 

 

 

 

New Medical Devices Rules and regulations covers Manufacturing of In vitro diagnostic kits or IVD Kits  through SUGAM ,an online platform, Made by Central Drugs Standard Control Organisation has been created to allow manufacturers to submit applications online.

Manufacturers who wish to manufacture IVD Kits in Class A and B need to submit a Online application on SUGAM Portal and the approval for the same will be granted by State Licensing Authority whereas Manufacturers who wish to manufacture products in Class C and D need to submit a Online application on SUGAM and the approval shall be granted by CDSCO.

New In – Vitro Diagnostic Kits are diagnostic kits which have not been approved in Indian either for Import or Manufacture by the Central Licensing Authority i.e. CDSCO.

The predicate or similar products for such kits have not yet been approved by CDSCO.

As per the New Medical Devices Rules  2017 and Regulations, a Clinical Investigation specifically Clinical Performance Evaluation has to be administered to assess the safety and efficacy of the Proposed new IVD Kits.

In cases of New IVD Kits, classified under Class A, data on clinical performance evaluation may NOT be necessary depending on the nature of such IVD Kit.

As per Medical Device Rules 2017, Application seeking grant for Clinical Performance Evaluation of a NEW IVD KIT needs to be filed into CDSCO in FORM 24 and the approval to conduct the Clinical Performance Evaluation will be granted in FORM 25.

Once the safety and Efficacy of the IVD Kit is proved to be Safe for Indian population , an application for Import or Manufacture of this Diagnostic Kit has to be filled with the CDSCO on Online Portal SUGAM.

If after Clinical Performance Evaluation , it is found that the the proposed new IVD KIT is safe for use on Indian Population, then a Manufacturer or Importer can submit application for seeking grant of permission to Manufacture or Import the new IVD KIT in Form 28 and the corresponding approval will be granted in FORM 29.

Approval for NEW IVD Kits is a long and tedious regulatory procedure.

Diagnostic Kit