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
- Notified Medical Device Registration
- 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.NO | Medical Device |
1 | Disposable Hypodermic Syringes |
2 | Disposable Hypodermic Needles |
3 | Disposable Perfusion Sets |
4 | Substances used for in vitro diagnosis including Blood Grouping Sera |
5 | Cardiac Stents |
6 | Drug Eluting Stents |
7 | Catheters |
8 | Intraocular Lenses |
9 | I.V. Cannulae |
10 | Bone Cements |
11 | Heart Valves |
12 | Scalp Vein Set |
13 | Orthopedic Implants |
14 | Internal Prosthetic Replacements |
15 | Ablation Devices |
16 | Ligatures, Sutures and Staplers |
17 | Intrauterine Devices (Cu-T) |
18 | Condoms |
19 | Tubal Rings |
20 | Surgical Dressings |
21 | Umbilical tapes |
22 | Blood/Blood Component Bags |
23 | Organ Preservative Solution* |
24 | Nebulizer (effective from 1 Jan.2021) |
25 | Blood Pressure Monitoring Device(effective from 1 Jan.2021) |
26 | Glucometer (effective from 1 Jan.2021) |
27 | Digital Thermometer (effective from 1 Jan.2021) |
28 | All implantable medical devices Equipment (effective from 1, April,2021) |
29 | CT Scan Equipment (effective from 1, April,2021) |
30 | MRI Equipment (effective from 1, April,2021 |
31 | Defibrillators (effective from 1, April,2021) |
32 | PET Equipment(effective from 1, April,2021) |
33 | X-Ray Machine (effective from 1, April,2021) |
34 | Dialysis Machine (effective from 1, April,2021) |
35 | Bone marrow cell separator (effective from 1, April,2021) |
36 | Disinfectants and insecticide specified in Medical Devices Rules, 2017 |
37 | Ultrasound 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
- Plant registration certificate
- Free Sale Certificate
- Quality Management System certificate or Full Quality Assurance certificate or
Production Quality Assurance certificate i - Latest inspection or audit report
- Device description, intended use of the device, specification including variants
and accessories; - Material of construction
- Working principle and use of a novel technology (if any);
- Labels, package inserts (IFU, etc.,), user manual, wherever applicable,
- Summary of any reported Serious Adverse Event in India or in any of the
countries where device is marketed - Site or plant master file as specified in Appendix I of this Schedule;
- Essential principles checklist for demonstrating conformity to the essential
principles of safety and performance of the medical device; - Undertaking signed by the manufacturer stating that the manufacturing site is in
compliance with the provisions of the Fifth Schedule; - Wholesale license
- Constitutional details
- POA
- Legal Form MD-14
The manufacturer will have to primarily have to focus on compiling the following documents for Class B,C and D-
- Power of Attorney
- FSC County of Origin
- FSC – USA, EU, Canada, Japan, Australia
- ISO Certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Declaration of Conformity
- Predicate Device Information
- Labels
- IFU
- Batch release certificates for minimum 3 batches
- Audit Report
- Domestic Price list- Country of Origin
- Details of Product Recall
- Details of CAPA
- Post Market Surveillance Report
- Old Registration Certificate from CDSCO (if any)
- Adverse Events Globally
- Adverse Events India
- Quality Manual
- Schedule DII
- 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.
- These rules are called the Medical Devices (Amendment) Rules, 2020.
- These rules shall come into force on the 1st day of April, 2020.
- 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 –
- Name of the company or firm or any other entity importing the medical device, specification and standards of the particular medical device
- Details of medical device
- 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
- FSC – Country of Origin
- 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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