Regulatory ESSENTIAL



Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

INMETRO Certification; Medical Devices; medical devices class i; UDI Code; sterile packaging; clinical evaluation; IMDRF; ISO 15223-1 symbol; vigilance;
Scope: This ESSENTIAL describes the regulatory requirements of medical devices in India, based on - The Drugs and Cosmetics Act - Medical Devices Rules, 2017 - CDSCO Guidance Documents - BIS Certification Rules (for special electric/electronic devices included in medical devices). Health products in India are classified into four risk classes. Not in scope of this CRF (although also regulated by the Medical Devices Rules, 2017) - In-Vitro Diagnostics (see: ESSENTIAL IND In-Vitro Diagnostics) For the certification of electronic products integrated into medical devices, see the Regulatory ESSENTIAL ESS IND Electrical Safety - CRS Electronic and IT products.

Stakeholders: Manufacturer, Importer, B2C products, B2B products
Legislation in force: THE DRUGS AND COSMETICS ACT, 1940 (abb. The Act) “drug” includes - (iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as maybe specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board Medical Devices Rules, 2017 (amendments included), abb. MDR-2017 Content: CHAPTER I - Preliminary (Definitions etc.) CHAPTER II - Regulation of Medical Device CHAPTER III - Authorities, Offices and Bodies CHAPTER III B - Registration of Class A (non-sterile and non-measuring) Medical Devices CHAPTER IV - Manufacture of Medical Devices for Sale or for Distribution CHAPTER V - Import of Medical Devices CHAPTER VI - Labelling of Medical Devices CHAPTER VII - Clinical Investigation of Medical Device and Clinical Performance Evaluation of new In Vitro Diagnostic Medical Device CHAPTER VIII - Import or Manufacture Medical Device which does not have Predicate Device CHAPTER IX - Duties of Medical Device Officer, Medical Device Testing Officer and Notified Body CHAPTER X - Registration of Laboratory for carrying out Test or Evaluation CHAPTER XI - Sale of Medical Devices CHAPTER XII - Miscellaneous 1. SCHEDULE - Parameters for Classification of Medical Devices and In Vitro Diagnostic Medical Devices 2. SCHEDULE - Fee Payable for License, Permission and Registration Certificate 3. SCHEDULE - Documents required for Registration of Notified Body, its Duties and Functions 4. SCHEDULE - Documents Required for Grant of License to Manufacture for Sale or for Distribution or Import 5. SCHEDULE - Quality Management System for Medical Devices and In Vitro Diagnostic Medical Devices 6. SCHEDULE - Post Approval Change 7. SCHEDULE - Requirements for Permission to Import or Manufacture Investigational Medical Device for Conducting Clinical Investigation 8. SCHEDULE - Exemptions APPENDIX - Forms (Form MD-1 - Form MD-43)

Application national:

Countries: Image for IN India,  
Comment on the comparability to EU legislation: Medical Device certificates from national authorities of the European Union are accepted....
Status: Published 2024-02-23 by Anette Dunkel-Reinboth and Torsten Sahm
Last change 2024-03-05 by Torsten Sahm: Comment on the comparability to EU legislation , Medical devices
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Scope of this ESSENTIAL
This ESSENTIAL describes the regulatory requirements of medical devices in India, based on
- The Drugs and Cosmetics Act
- Medical Devices Rules, 2017
- CDSCO Guidance Documents
- BIS Certification Rules (for special electric/electronic devices included in medical devices).

Health products in India are classified into four risk classes.

Not in scope of this ESSENTIAL (although also regulated by the Medical Devices Rules, 2017)
- In-Vitro Diagnostics (see: ESSENTIAL IND In-Vitro Diagnostics)

For the certification of electronic products integrated into medical devices, see the Regulatory ESSENTIAL ESS IND Electrical Safety - CRS Electronic and IT products.'

Abbreviations
Here you will get textual information

Important abbreviations which are special for this legislation or theme.

Analysis of regulatory requirements

Legislation in force for this PCT
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation
Health products in India are classified into four risk classes, according to the risk classification:
Class A - low risk (sub-divided into 2 risk classes)
Class B - low moderate risk
Class C - moderate high risk
Class D - high risk'

Responsible actors
Here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
Here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Penalty by this legislation
Here you will get textual information

What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

Exemption clauses
Here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
Here you will get textual information

E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
Here you will get related hyperlink(s)

Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
Here you will get related hyperlink(s)

Name of the authority for approval, registration, market surveillance and/or enforcement

Market surveillance authority
Here you will get related hyperlink(s)

Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
Here you will get related hyperlink(s)

Comment on the comparability to EU legislation
Here you will get textual information

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
Here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Registration at related authority required?
Here you will get related hyperlink(s)

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
Here you will get textual information

[Yes/No]

IMDRF Membership
Here you will get textual information

Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Database Entry required
Here you will get textual information

Hints
Here you will get related hyperlink(s)

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Classification Rules
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Approval process (conformity assessment procedure)
Here you will get a table

Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)
Here you will get a image or chart

Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)
Here you will get related hyperlink(s)

Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority
Here you will get textual information

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal
Here you will get textual information

Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?
Here you will get textual information

e .g. formal application

Is a factory inspection legally required
Here you will get textual information

Is a factory inspection legally required
Here you will get related hyperlink(s)

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Testing & Standards

General information to the application of standards
Here you will get textual information

e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment
Here you will get related hyperlink(s)

National Standardisation Organisation
Here you will get related hyperlink(s)

Link to organisation

Are national standards based on IEC/ISO standards?
Here you will get textual information

Undetailed information

Clinical Investigation/Evaluation
Here you will get textual information

Is in-country testing legally required?
Here you will get related hyperlink(s)

Acceptance of foreign test reports
Here you will get textual information

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get textual information

e. g. product label

Regulatory label (mandatory)
Here you will get a image or chart

e. g. product label

Regulatory e-labelling allowed?
Here you will get textual information

e. g. put the regulatory information and labels in a software menu

UDI marking
Here you will get textual information

Required information on the product and/or packaging
Here you will get textual information

e. g. address of the manufacturer/importer, serial number

User instructions language(s)
Here you will get textual information

Regulated by the legal provisions

User instruction requirements and specific compliance notes
Here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Digital user documentation allowed?
Here you will get textual information

User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?

Medical Device Symbols
Here you will get textual information

Hints
Here you will get textual information

Specific recommendations, information or most common mistakes


Code, ContinentIND, Asia
Economic Area
Official LanguageEnglish, Hindi (plus 21 official local languages) - The Official Languages Act, 1963 | https://www.indiacode.nic.in/handle/123456789/1526?sam_handle=123456789/1362
Standard InstituteBIS Bureau of Indian Standards | https://www.bis.gov.in/
HS CodememberYes






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