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MEDICAL DEVICE RULES, 2017 - the Process, Structure, and Compliance Stages

The Medical Device Rules of 2017, a comprehensive regulatory framework governing the medical device industry in India, encompass a multifaceted landscape of 97 rules, structured within 12 chapters and accompanied by 8 schedules that define essential parameters, requirements, procedures, fees, and documentation prerequisites. Within this expansive framework lie over 42 crucial forms designed to address every facet of medical device acquisition, registration, and the procurement of import, export, and manufacturing licenses. As the guardian of safety, efficacy, and quality within the healthcare ecosystem, the Medical Device Rules of 2017 usher in a new era of regulatory standards that guide and safeguard the entire medical device journey – from development and manufacturing to market entry and patient care. 

Primarily the Medical Devices including In-vitro diagnostic devices comes under the Ministry of Health and family Welfare, a autonomus govenrning body which is now National Regulatory Authority herein reffered as CDSCO (Central Drugs Standard Control Organisation). The CDSCO governs all the Healthcare System in India under the guidance of MoH&FW. 

The Medical Device Rules of 2017, introduced in India, aim to regulate and standardize the medical device industry to ensure the safety and efficacy of medical devices. Here are some of the key features of these rules:

  • Unique Device Identification (UDI): The implementation of Unique Device Identification (UDI) for medical devices allows for easy traceability and identification of products. This system enhances post-market surveillance and safety monitoring by uniquely labeling each device.
  • Enhanced Quality Checks: To ensure patient safety, the rules incorporate stringent quality checks and compliance measures. This includes oversight from Notified Bodies (NB), the Medical Device Testing Laboratory (MDTL), and compliance with Bureau of Indian Standards (BIS) requirements, among others.
  • Listing of Manufacturers: Manufacturers of medical devices are required to register and list their products on a public database. This transparency provides healthcare professionals and patients with information about the source and specifications of the devices they use.
  • Single Window-Online System: The introduction of a single window-online system streamlines various processes related to medical devices. This unified platform simplifies tasks such as registration, licensing, and compliance, making it more efficient for stakeholders.
  • Prioritization of BIS Standards: In many cases, the rules prioritize compliance with Bureau of Indian Standards (BIS) standards over ISO/IEC standards. This prioritization ensures that devices conform to specific Indian standards, where applicable, in addition to international norms.
As per the Medical Device Rules 2017, the Central Drugs Standard Control Organisation, MoHF&W released a Statuary Order [S.O. 648(E)] the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs;

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.

Note: Considering the medical device as "drugs" is solely meant for make fit the Medical Devices with Drugs and Cosmetic Acts 1940, however the medical devices are governed, licensed and operated as per Medical Device Rules 2017, Drugs and Cosmetic Act 1940 governs the Healthcare Sector of India which covers all items inntended to used for public health in any means. 

Under Medical Device Rules, The Class A - (Non-Measuring and Non-Sterile) devices are exempted to Licensing, However they are obliged to be registered as per Chapter III-B of Medical Device Rules. 

Documentation Requirements in Accordance with Fourth and Fifth Schedule; 

Title of Documents Class A Class B Class C Class D Import License
Company Legal Documents Y Y Y Y Y
Plant/Site Master File Y Y Y Y Y
NOCs from CGWA/Industrial Authority Y Y Y X (Conditionally) NA
Technical Person Appointment (Minimum Two) Y Y Y Y Y
List of Machines & Testing Equipment’s Y Y Y Y Y
Device Master File NA Y Y Y Y
Device Description (Including regulatory Status) Y Y Y Y Y
Device Specification Y Y Y Y Y
Product Specification Y Y Y Y Y
List of Models and Variants along with Specification Y Y Y Y Y
Design and Development Exempted X (Conditionally) Y Y Y
Manufacturing Process Y Y Y Y Y
Labelling and Product Brochures Y Y Y Y Y
User Manual Y Y Y Y Y
Essential Principle Requirements Y Y Y Y Y
Risk Assessment Exempted Y Y Y Y
Design Verification and Validation Exempted Exempted Y Y Y
Product In-House Test Reports & Performance validation Exempted Y Y Y Y
General Electrical Safety Reports X (Conditionally) Y Y Y Y
Electromagnetic Interference Reports X (Conditionally) Y Y Y Y
Product Specific Standard Test Reports NA Y Y Y Y
Biocompatibility Reports X (Conditionally) X (Conditionally) X (Conditionally) Y Y
Shelf Life and Usability Studies If Claimed If Claimed If Claimed Y Y
Clinical Evaluation Exempted Y Y Y Y
Performance Evaluation Report (Only For IVDs) Exempted Y Y Y Y
Post Market Surveillance Reports X (Conditionally) Y Y Y Y
Periodic Safety Update Reports Exempted Exempted X (Conditionally) X (Conditionally) X (Conditionally)
Declaration Certificate of Compliance Y Y Y Y Y
DoC (Certificate of Conformity) Y Y Y Y Y
Audit Reports (From Notified Bodies/Competent Authority) Exempted Y Y Y Y

Although Documents requirements depend upon the nature of device and Intended use claimed by the Manufacturer, which may be fullfilled by the other documentation. 

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