NKG team has a cumulative experience of more than 50 Years in Regulatory affairs. Over years, our experts have been Behind breakthrough Medical Devices Technology approvals by helping Medical Device companies from India and the World with a clear Regulatory Pathway for Successful Launch of their products under Medical Device Rules in India.
As per New Notified definition of Medical Device Medical Device Rules 2017, Medical Device means –
There are 37 categories of Notified Medical Devices under these rules.
On 11th Feb 2020, CDSCO, Ministry of Health and Family Welfare further elaborated the NEW Definition of Medical Devices for the “New Notified Medical Devices”
All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.
This means all Medical Devices which were not notified before February 11, 2020 (i.e. other than the list of 37 categories of medical devices), and will now be covered by the new definition of medical devices.
So why are Devices defined as Drugs?
Medical devices in India are regulated under the Drugs and Cosmetics Act 1940 (DCA). Within the DCA, from time to time, medical devices are first notified as drugs to come under the purview of the act. Even more so, the Medical Device Rules 2017 have also been framed under the DCA. Therefore, all medical devices are first notified as drugs under DCA so that they can ultimately be regulated under the new Medical Device Rules 2017.
DOWNLOAD NOTIFICATION S.O. 648(E)There was a time when the concept of medical devices 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 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 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 medical devices 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 devices 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.
With the ever increasing innovation in medical devices Government has also been including many devices in the ambit of regulation for licences and as latest as on 11th February 2020, Government of India also revised the definition of medical devices through S.O. No. 648 to cover all devices under the definition of drugs.
This expansion of medical device regulations to cover all devices 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 to such regulations and ensure that the Indian Consumers are assured safe and quality medical device products.
It became compulsory for the medical devices entering India to be in compliance with the Indian Medical Device Regulations set forth by the CDSCO
There are about 37 device “families” that outline the medical devices that need to be registered.
Class A -Low Risk, Class B- Low Moderate Risk, Class C – Moderate High Risk and Class D – High Risk
The New Medical Devices Regulations came into Effect from January 2018 giving a Separate Regulatory identity to the Medical devices and Invitro Diagnostic Devices.To ensure Patient Safety the devices were delinked from drugs and the New medical Devices Regulations were formulated to ensure and Check Quality, Performance of Devices being sold in the country.
MARCH
DOWNLOAD NOTIFICATION GSR 365 (E)Disposable Hypodermic Syringes
Disposable Hypodermic Needles
Disposable Perfusion Sets
SEPTEMBER
DOWNLOAD NOTIFICATION GSR 601 (E)Substances used for in vitro diagnosis including Blood Grouping Sera
OCTOBER
DOWNLOAD NOTIFICATION S.O.1468 (E)Cardiac Stents
Drug Eluting Stents
Catheters
Intra Ocular Lenses
I.V. Cannulae
Bone Cements
Heart Valves
Scalp Vein Set
Orthopedic Implants
Internal Prosthetic Replacements
NOVEMBER
DOWNLOAD File No- 29/Misc.3/2017-DC (292)Disinfectants and insecticide specified in Medical Devices Rules, 2017
AUGUST
DOWNLOAD File No. 29/Misc/3/2018-DC(18)Ligatures, Sutures and Staplers
Intra Uterine Devices (Cu-T) – CDSCO Category (Contraceptives)
Condoms -CDSCO Category (Contraceptives)
Tubal Rings- CDSCO Category
(Contraceptives)
Surgical Dressings
Umbilical tapes
Blood/Blood Component Bags
JANUARY
DOWNLOAD File No. 29/Misc/3/2018-DC(18)Nebulizer
Blood Pressure Monitoring Device
Glucometer
Digital Thermometer
All implantable medical devices Equipment
CT Scan Equipment
MRI Equipment
Defibrillators
PET Equipment
X-Ray Machine
Dialysis Machine
Bone marrow cell separator
In line with risk based classification of Global Harminozation task Force (GHTF), under the Medical Devices Rules 2017, Medical Device 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). Medical Devices are classified as surgical or non-surgical devices based on a device’s invasiveness.
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 Medical Devices falling under Class C & Class D in case of medical Devices manufactured in India. In case of imported Medical Devices, All classes from A to D are regulated by CDSCO.
Medical Devices 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 medical devices falling under Class A & Class B.
Medical devices belonging to class A need not be licensed and shall remain self-regulated as per applicable standards.
# |
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.1,00,000 |
|
|
| 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/- |
|
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 Medical Devices
NKG holds a valid stock and sale license (Form 20B and 21B) to assist foreign manufacturers to import their medical devices 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.
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Medical Devices which are imported 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.
know more about this serviceIn case an Importer or manufacturer of a medical device intends to import small quantities of a medical device 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 helps them in obtaining the respective test license for medical device imports for the above mentioned purposes.
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New Medical Devices Rules and regulations covers Manufacturing of Medical devices and In vitro diagnostic device. SUGAM ,a online platform, Made by Central Drugs Standard Control Organisation has been created to allow manufacturers to submit applications online.
Manufacturers who wish to manufacture Products 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.
Medical Devices which are manufactured need to be registered under the Medical Device Rules 2017. Under these rules, An application for seeking manufacturing permission must be submitted based on the risk class of the medical device to concerned authority.
In case of Class A & Class B medical devices , a manufacturer needs to apply for a permission or manufacturing license to the State Licensing Authority of the state where the manufacturing premises exist.
In Case a manufacturer wishes to apply for a Loan License to manufacture Class A & Class B medical devices, the manufacturer will need to submit an application for seeking permission to the State Licensing Authority of the state where the manufacturing premises exist.
know more about this serviceMedical Devices which are manufactured need to be registered under the Medical Device Rules 2017. Under these rules, An application for seeking manufacturing permission must be submitted based on the risk class of the medical device to concerned authority.
In case of Class C & Class D medical devices , a manufacturer needs to apply for a permission or manufacturing license to the Central Licensing Authority i.e. CDSCO.
In Case a manufacturer wishes to apply for a Loan License to manufacture Class C & Class D medical devices, the manufacturer will need to submit an application for seeking permission to the Central Licensing Authority i.e. CDSCO.
know more about this serviceIn case the manufacturer of a medical device intends to Manufacture small quantities of a medical device for the purpose of training or demonstration or clinical investigations or for the purpose of testing , an application for Test License to manufacture such products can be submitted to CDSCO under the new Medical Device Rules 2017.
The new Medical Device Rules 2017 require the manufacturer to obtain a test license by applying for it using Form MD-12. Further, the test license for manufacturing medical devices for above mentioned purposes will be granted as permission through Form-13.
The technical team at NKG ABC guides applicants, through this process and will helps them in obtaining the respective test license for medical device imports for the above mentioned purposes.
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New Medical Devices are those products whose Predicate or similar product is not yet approved by the Indian Regulatory Body Namely- CDSCO.
As per the New Medical Devices Rules and Regulations, a Clinical Investigation has to be administered to assess the safety and efficacy of the Proposed medical Devices.
Once the safety and Efficacy of the Device is proved to be Safe for Indian population , an application for Import or Manufacture of this Medical Device has to be filled with the CDSCO on Online Portal SUGAM.
Research is an ongoing subject and Science is never stagnant. Newer Medical Devices are being researched and developed worldwide to be Launched for better health of global consumers.
In cases where a medical device is being developed and never been approved by any regulatory authority in the world, the medical device or pharmaceutical companies working on developing such medical devices need to conduct various tests and investigate the possible outcomes of such tests.
Therefore, in order to Check the Safety ,Efficacy & Performance of such Devices , Medical device companies need to seek prior permission from CDSCO to conduct Clinical investigation of such investigational medical devices. This is long and critically important process, NKG experts make the process simpler.
The Ministry of Health and Family Welfare, Government of India has published the 5th Amendment of Medical Device Rule vide General Statutory Rule (G.S.R.) 754(E) on 30th September 2022. This Rule has made provision for Registration Certificate to sell, stock, exhibit, or offer for sale or distribute a medical device including In-Vitro diagnostic device.
It means if you are a retailer, wholesaler, or stockist of medical devices including IVDs, you must get a registration certificate from the state licensing authority on Form MD-42. The MD 42 Registration Certificate is mandatory from 30 September 2022.
“What is MD 41?
MD 41 is the Application Form to be submitted by the retailer, wholesaler, or stockiest to the State Licensing Authority to get the Medical Device Registration Certificate on form MD 42.
What is MD 42?
MD 42 is the Legal Medical Device Registration Certificate issued by the State Licensing Authority to the retailer, wholesaler, or stockiest to sell, stock, exhibit, or offer for sale or distribute a medical device including In-Vitro diagnostic device.”
NKG Has assisted More than 2000 Brands and Registered more than Half a Million Skus and NKG Experts has a Clear Overview of the Claims accepted by the Department.
NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
