MEDICAL DEVICES

REGULATORY SERVICES

Clini Counsel team has a cumulative experience of more than 10+ 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 –

  1. substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i),
  2. substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii),
  3. devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act;

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.

DOWNLOAD NOTIFICATION S.O. 648(E)

There was a time in India when the idea of medical devices was not widely used. In addition, no matter what systems or equipment were accessible, there was no control over the quality element, and patients as a whole had to suffer due to either poor quality or a lack of high-quality devices to treat a variety of illnesses. The Ministry of Health and Family Welfare, Government of India, took the aforementioned issues seriously and determined that it was necessary to pass a law regulating medical devices, including intravenous diagnostic medical devices, in order for all Indian manufacturers and foreign suppliers to be covered by the guidelines of the aforementioned regulations issued by the Central Drugs Standard Control Organisation.

As a result, the government passed a law in 2006 that regulated all forms of medical equipment deemed necessary at the time. Another clause was maintained that allowed the government to regulate any additional high-tech devices and diagnostics. This undoubtedly contributed significantly to the nation’s access to high-quality goods. In order to direct control on the quality of products by manufacturers and exporters to India, the government has been bringing more and more medical equipment under regulation. The National Pharmaceutical Pricing authority also intervened and regulated the Prices of the Devices since it was felt by the government that the prices of several devices had been rising dramatically over time and were sometimes out of reach for the general public.

Given the ongoing advancement in medical technology Many gadgets are now covered by government regulations for licences, and as recently as February 11, 2020, the Indian government amended the definition of medical devices by issuing S.O. No. 648 to include all devices under the category of pharmaceuticals.

It is now required for all devices being sold in the nation to be registered as a result of the expansion of medical device rules to embrace all gadgets. The government has also given Indian manufacturers and outside suppliers enough time to adapt to these laws and make sure that Indian consumers would only receive high-quality, safe medical device items.

Disposable Hypodermic Syringes
Disposable Hypodermic Needles
Disposable Perfusion Sets

DOWNLOAD NOTIFICATION GSR 365 (E)

CLASSIFICATION IN INDIA

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

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.

SLA

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.

LICENSES, CLASS AND GOVT. FEES

 

#
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/-
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 Medical Devices

We understands the needs of global brand owners and offers bespoke services to such Brand Owners or manufacturers. We 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)

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.

Our 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 MEDICAL DEVICE (FORM MD-16, FORM MD-17)

In 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 our group guides applicants, through this process and will helps them in obtaining the respective test license for medical device imports for the above mentioned purposes.

 

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.

Medical Device