Background For Medical Device Amendments

This article details the Medical Device Amendments which have been amended in 2020. The history of Medical Device Regulation starts with the Central Drugs Standard Control Organization (CDSCO). The CDSCO is the Indian Advisory Body for Pharmaceuticals and Medical Devices wherein all Notified Medical Products are regulated by them. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO for product approvals in India. The CDSCO is responsible for approval and regulation Drugs, Cosmetics, IVD’s and Medical Devices, control over the quality of Imported Devices, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Manufacturers can leverage their approvals in the US, Canada, Europe, Australia or Japan for the Registration Process in India.

Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940 is an Act of the Indian Parliament which is responsible for the regulation of Importation, Manufacturing and Distribution of Drugs, Cosmetics, Medical Devices and IVD’s in India. The most important objective of this Act is to enforce that quality standards are adhered to and every device imported into India is protected. This article focuses on the regulation of Medical Devices in India. For this, there are two major pathways – 

There are two major pathways for the registration of medical devices in India

  1. Notified Medical Device Registration
  2. Non-Notified Medical Device Registration

1) Notified Medical Device Registration

For Medical Device Registration in India, 37 device categories have been listed as ‘Notified Medical Devices’ by the CDSCO.  List of notified medical devices is given below. All the Medical devices under the new Rules “Medical Devices Rules, 2017” are classified as per Global Harmonization Task Force (GHTF) based on associated risks,

  • Class A (low risk)
  • Class B (low moderate risk)
  • Class C (moderate high risk)
  • Class D (high risk)
S.NOMedical Device
1Disposable Hypodermic Syringes 
2Disposable Hypodermic Needles 
3Disposable Perfusion Sets
4Substances used for in vitro diagnosis including Blood Grouping Sera 
5Cardiac Stents
6 Drug Eluting Stents 
7Catheters 
8Intraocular Lenses
9I.V. Cannulae
10Bone Cements
11Heart Valves
12Scalp Vein Set
13Orthopedic Implants
14Internal Prosthetic Replacements
15Ablation Devices
16Ligatures, Sutures and Staplers 
17Intrauterine Devices (Cu-T)
18Condoms
19Tubal Rings
20Surgical Dressings 
21Umbilical tapes
22Blood/Blood Component Bags
23Organ Preservative Solution* 
24Nebulizer (effective from 1 Jan.2021) 
25Blood Pressure Monitoring Device(effective from 1 Jan.2021)
26Glucometer (effective from 1 Jan.2021)
27Digital Thermometer (effective from 1 Jan.2021)
28All implantable medical devices Equipment (effective from 1, April,2021)
29CT Scan Equipment (effective from 1, April,2021)
30MRI Equipment (effective from 1, April,2021
31Defibrillators (effective from 1, April,2021) 
32PET Equipment(effective from 1, April,2021) 
33X-Ray Machine (effective from 1, April,2021)
34Dialysis Machine (effective from 1, April,2021)
35Bone marrow cell separator (effective from 1, April,2021) 
36Disinfectants and insecticide specified in Medical Devices Rules, 2017 
37Ultrasound equipment (effective from 1, November, 2020)

The process to register the above mentioned 37 devices is – 

Step 1 : Determination of Classification of Medical Device

When a manufacturer decides to get their products registered in India, he/she must review the CDSCO’s gazette notifications prior to making a final determination of a device’s regulatory status and classification

Step 2 : Appointment of Indian Agent 

The manufacturer must appoint an India Authorized Agent to interact with the CDSCO. The agent chosen must have a wholesale license (Forms 20B and 21B/21C). The Indian Agent will then be granted a Power Of Attorney to manage registration and importation in India.

Step 3 : Compilation of Documents

The manufacturer will have to primarily have to focus on compiling the following documents for Class A

  1. Plant registration certificate
  2. Free Sale Certificate
  3. Quality Management System certificate or Full Quality Assurance certificate or
    Production Quality Assurance certificate i
  4. Latest inspection or audit report
  5. Device description, intended use of the device, specification including variants
    and accessories;
  6. Material of construction
  7. Working principle and use of a novel technology (if any);
  8. Labels, package inserts (IFU, etc.,), user manual, wherever applicable,
  9. Summary of any reported Serious Adverse Event in India or in any of the
    countries where device is marketed
  10. Site or plant master file as specified in Appendix I of this Schedule;
  11. Essential principles checklist for demonstrating conformity to the essential
    principles of safety and performance of the medical device;
  12. Undertaking signed by the manufacturer stating that the manufacturing site is in
    compliance with the provisions of the Fifth Schedule;
  13. Wholesale license
  14. Constitutional details
  15. POA
  16. Legal Form MD-14

The manufacturer will have to primarily have to focus on compiling the following documents for Class B,C and D- 

  1. Power of Attorney 
  2. FSC County of Origin
  3. FSC – USA, EU, Canada, Japan, Australia 
  4. ISO Certificate 
  5. Full Quality Assurance Certificate 
  6. CE Design Certificate 
  7. Declaration of Conformity 
  8. Predicate Device Information 
  9. Labels 
  10. IFU
  11. Batch release certificates for minimum 3 batches 
  12. Audit Report 
  13. Domestic Price list- Country of Origin 
  14. Details of Product Recall 
  15. Details of CAPA 
  16. Post Market Surveillance Report
  17. Old Registration Certificate from CDSCO (if any) 
  18. Adverse Events Globally 
  19. Adverse Events India
  20. Quality Manual 
  21. Schedule DII 
  22. MD-14 application

Step 5 : Process and Timelines 

The next step is the file application for registration/Import License with the CDSCO (CDSCO fees is at actuals). All documents submitted must be in English. The time period for obtaining Registration certificate of Medical Devices in India is 6-9 months. The clock stops once a query is raised and starts once responded to. New products without any strong predicates in India may take longer time and / or require a MDAC review for approval based on the recommendations by the CDSCO. After obtaining the license, the manufacturer must understand that the license does not expire. License retention fees are due every five years.

Step 6 : Importation

The manufacturer can import their device into the country only via the Authorized Indian Agent.

2) Non-Notified Medical Device Registration

 Medical Device Amendments

The CDSCO brought in a new amendment on 11th February 2020,  wherein apart from above mentioned 37 notified devices, all the other devices which includes – instruments, apparatus, appliances and implants, irrespective of being used alone or in combination for various purposes like analysis, prevention, treatment, allaying of any disease, investigation, replacement or alteration or support of the anatomy among others, will be regulated under the legislation.

  1. These rules are called the Medical Devices (Amendment) Rules, 2020. 
  2. These rules shall come into force on the 1st day of April, 2020. 
  3. In the Medical Devices Rules, 2017 (hereinafter to be referred as said rules), after CHAPTER III, the following CHAPTER IIIA shall be inserted

Registration under this chapter will be on a voluntary basis for 18 months from 1st April 2020 to 1st October 2021

The process to obtain registration for non-notified devices under the Medical Device Amendments would be as follows- 

Step 1 : Check Gazette Notification

When a manufacturer decides to get their products registered in India, he/she must review the CDSCO’s gazette notifications to understand if the product falls under a notified or non-notified category.

Step 2 : Appointment of Indian Agent

The manufacturer must appoint an Indian Agent who will handle the submission of documents and help obtain the registration number for a non-notified device. 

Step 3 :  Compilation of Documents

The importer will have to compile the following documents – 

  1. Name of the company or firm or any other entity importing the medical device,  specification and standards of the particular medical device 
  2. Details of medical device
  3. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device 
  4. FSC – Country of Origin 
  5. Undertaking signed by the importer stating that the information provided by the applicant is true and authentic

Step 4 : Process and Verification

Once the documents are submitted, the CDSCO will give a registration number for the particular medical device. The importer will then have to mention the registration number on the label of the medical device. The Central Licensing Authority will verify the documents at any point of time and investigate quality or safety related failure or complaints.  If the manufacturer fails to comply with the provision of the new rules, the Central Licensing Authority may cancel the registration number or suspend it for a period of time. 

Step 5 : Importation 

The manufacturer can import their device into the country only via the Authorized Indian Agent.

How can Morulaa Help 

Morulaa HealthTech as successful regulatory consultants has delivered high level professionalism and quality towards our clients. Contact Harshita Gupta for additional consultation or information.


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