India: Materiovigilance Programme Of India (MvPI) Issues Draft Guidance On Medical Devices

The medical device segment in India, considered Asia's fourth largest market worth approximately USD 5.5 billion and expanding at a steady pace, presents an exciting business landscape and opportunities for both domestic as well as international manufacturers/entrepreneurs. At present, India's medical device sector is dominated by multinational companies, which is evident from the fact that India relies on imports of medical devices (about 75-80% of the sales are generated by imported medical devices) for supply to its healthcare system. Over the years, many multi-nationals have set up operations in India.

On August 06, 2018, the Indian Pharmacopoeia Commission (IPC), the National Coordinating Centre (NCC) of Materiovigilance Programme of India (MvPI) released Draft Guidance Document for Medical Devices1 to provide necessary information to all the stakeholders of the country regarding the regulatory requirements, quality management systems and standards required to be followed for medical devices. The new draft includes standards for medical devices as a Guidance Document for the benefit of the general public, patients and healthcare professionals. It will also serve as a reference manual for the licensing authority in the matters relating to medical devices. The guideline also describes post-market requirements for medical devices.

However, the nature of majority of the operations in India is to only distribute imported devices and provide support function. From this view, the purpose of this document:

  • Aims to be informative in nature on medical device standards comprehensively, irrespective of usage i.e. whether on human beings and animals. Preparation of standards on medical devices nationally and internationally is an ongoing process, irrespective of regulation on same by National/State Medical Devices Regulator.
  • Provide guidance to assist manufacturers, traders/distributors, importers, clinical establishments, healthcare professionals and general public on nationally-recognized medical devices standards and other regulatory requirements concerning medical devices in India.
  • Serves as ready reference for medical devices standards preparation/adoptions, clinical care quality bodies, nomenclature of medical devices, claims on medical devices and validation mechanism, existence of multiple regulatory bodies on medical devices and law (ACT) directly governing medical devices in India.

Medical device Regulation in India

The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services in Ministry of Health and Family Welfare (MoHFW), Government of India (GoI), is the National Regulatory Authority (NRA) responsible for approval of manufacturing, import, conduct of clinical trials, laying down standards, sale and distribution of medical devices through enforcement and implementation of the Medical Devices Rules, 2017, released dated 31st January 2017 by the MoHFW. As NRA, CDSCO has the responsibility to conduct MvPI wherein, Indian Pharmacopoeia Commission functions as NCC for MvPI. MvPI is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices being used in India can be based on data generated here. The programme is meant to monitor medical device-associated adverse events (MDAE), create awareness among healthcare professionals about the importance of MDAE reporting in India and to monitor the benefit-risk profile of medical devices.

The draft guidance for medical device covers the regulatory approval process, classifications and grouping methodology, quality management system, labelling requirements including post marketing surveillance as draft highlights described below:

Classification of medical devices

The draft guidance describes the basic principles and parameters involved in classification of medical devices & in vitro diagnostic medical devices (hereafter referred as IVD medical device) based on the below facts:

  • Classification of Medical devices based on the risk parameters as described, namely: (i) Low risk - Class A; (ii) Low moderate risk- Class B; (iii) Moderate high risk- Class C; (iv) High risk- Class D.
  • Classification of Medical devices and in-vitro diagnostic medical devices based on the intended use of the device and other parameters, where the basic principle like – Medical Device's intended purpose of use, intended to be used in combination with another device, software which drives a device or influences the use of a device, and intended to be used solely or principally in a specific part of the body are considered. Moreover, the various parameters like- invasive, non-invasive, surgically invasive and implantable nature along with the medical devices incorporating medicinal products shall also be considered during classification of devices.

However, the draft also lists medical devices and IVD medical devices class wise for reference purposes.

The essential principles of medical devices

This guidance document describes fundamental design and manufacturing requirements, referred to as "Essential Principles for Safety and Performance" that, when met, indicate a medical device including IVD medical device is safe and performs to its specification. The design and manufacturing requirements in this document are grouped in categories. This section will allow manufacturers to select the design and manufacturing requirements relevant to a particular medical device, and documenting the reasons for excluding the others.

Quality management system

This is for notified medical devices and IVD medical devices (fifth schedule of Medical Devices Rules 2017) where specific requirements for a quality management system shall be used by the manufacturer for the design and development, manufacture, packaging, labelling, testing, installation and servicing of medical devices and in-vitro diagnostics. If the manufacturer does not carry out design and development activity, the same shall be recorded in the quality management system. The manufacturer shall maintain conformity with this Schedule to reflect the exclusions.

The quality management system shall be applicable to manufacturers of finished devices, In vitro diagnostics, mechanical contraceptives (condoms, intrauterine devices and tubal rings), surgical dressings, surgical bandages, surgical staplers, surgical sutures and ligatures, blood and blood components collection bags with or without anticoagulants intended for human or animal use.

Regulatory approval process of Medical Devices in India

The guidance document describes the detailed process of registration and regulatory approval for manufacture for sale/distribution of medical devices and import of medical devices. This guidance also comprises the list of application forms and required documents and fee payable for license, permission and registration certificate to manufacture or import of medical devices. The draft also cites the audit fee payable to notified bodies registered with CDSCO to carry out audit of manufacturing sites under provisions of Medical Devices Rules, 2017.

Guidance on grouping of medical devices for product registration

The guidance explains the grouping of Medical Devices for a person who applies for license to import or manufacture for sale or distribution, sell, stock or offer for sale or distribution of medical devices as specified under respective forms to the Medical Devices Rules, 2017. The applicant may group medical devices having same or similar intended uses or commonality of technology and submit in a single application. The grouping of medical devices is for the purpose of submission of single application for license to import or manufacture in the following manner:

  • Single: A single medical device is a medical device sold as a distinct packaged entity and does not meet the criteria for family, IVD test kit, system, IVD cluster or a group. It may be sold in a range of package sizes. For example - Condoms sold in package of 3, 10 or 16, can be licensed as single medical device applications.
  • Family: A medical device family is a collection of medical devices and each medical device is from same license holder, is of same risk classification class, has a common intended use, has the same design and manufacturing process, and have variations that are within the scope of the permissible variants. For example - Condoms that differ in colour, size and texture but are manufactured from the same material and manufacturing process and share a common intended purpose can be licensed as a Family.
  • In vitro diagnostics Test Kit: An in-vitro diagnostics kit is a device that consists of reagents or articles which are from same license holder; intended to be used in combination to complete a specific intended purpose; sold under single proprietary test kit name; and compatible when used as a test kit. For example - Human Immunodeficiency Virus (HIV) Enzyme Linked Immunosorbent Assay (ELISA) Test Kit may contain controls, calibrators, and washing buffers. All the reagents and articles are used together to detect HIV and therefore, can be licensed as Test Kit. These reagents and articles can be supplied separately as replacement items for that particular Test Kit.
  • System: Medical devices comprise a system, when they are from same license holder; intended to be used in combination to complete a common intended purpose; compatible when used as system; and sold under single proprietary system name. for example - a glucose monitoring system comprising of a glucose meter, test strips, control solutions and linearity solutions can be licensed as a System.
  • In vitro diagnostics cluster: An in-vitro diagnostics cluster comprises of a number of in-vitro diagnostics reagents or articles which are from same license holder; of a common methodology; sold under single proprietary name; and compatible when used as a Test Kit.
  • Group: A medical device Group is a collection of two or more medical devices, supplied in a single package by same license holder, which are sold under single proprietary Group name and for a common intended purpose. For example - A first aid kit consisting of medical devices such as bandages, gauzes, drapes and thermometers, when assembled together as one package, can be licensed as a Group.

Labelling of medical devices and IVD medical devices

The guidance provides the labelling instructions of medical devices which are to be printed in indelible ink on the label, on the shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the medical device is packed, in case of small sized medical devices on which information cannot be printed legibly, shall include the information necessary for product identification and safety. Special instructions are required if:

  • Exemption of labelling requirements for export of medical devices - the labelling exemption of such device is intentional, to follow the specific requirements of law of the country to which the device is to be exported. However, the particulars like name of the device, the distinctive batch number or lot number or serial number, date of expiry, if any, the name and address of manufacturer, internationally recognized symbols in lieu of text, wherever required shall be adopted to meet the specific requirements of law of the country to which the device is to be exported.
  • Unique device identification of the medical device: With effect from 1st January 2022, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification which shall contain device identifier and production identifier.

Labelling medical device or a new in-vitro diagnostic medical device for purpose of test, evaluation, clinical investigations shall be kept in containers bearing labels, indicating the name of the product or code number, batch or lot number, serial number wherever applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.

Post market vigilance and safety requirements

MvPI has been approved since July 2015, which has Indian Pharmacopoeia Commission, Ghaziabad as the NCC for the Post market vigilance of medical devices. Presently, MvPI has 10 dedicated functional Medical Device Adverse Event Monitoring Centers (MDMCs) all over the country. All the Adverse Drugs Reaction Monitoring Centres (AMCs) under Pharmacovigilance Programme of India (PvPI) have also been entrusted to report adverse events due to the use of medical devices.

Scope of MvPI is to:

  • Create a nation-wide system for patient safety monitoring.
  • Analyze the benefit-risk ratio of medical devices.
  • Generate evidence-based information on safety of medical devices.
  • Support CDSCO in the decision-making process on use of medical devices.
  • Communicate the safety information on use of medical devices to various stakeholders to minimise the risk.
  • Emerge as a national centre of excellence for Materiovigilance activities.
  • Collaborate with other healthcare organizations for exchange of information and data management.

The adverse event reporting system of MvPI is described below2:

Note - Guidance document for Medical Devices is neither a regulatory nor a legal document. This document has been framed on the basis of Medical Device Rules 2017, issued by Government of India. If there are any errors or omissions found in this guidance document, readers are advised to refer to original Medical Device Rules 2017. The information contained in this document should not be a substitute for Medical Device Rules 2017.




The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Practice Guides
by Mondaq Advice Centres
Relevancy Powered by MondaqAI
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions