The Indian Government has finally introduced the Medical Device Rules, 2017 (“2017 Rules”) & it has come into effect on January 1, 2018.
Need of New Medical Device regulations: Medical device industry’s has been constantly putting their decade-long demand to separate the medical device industry from the pharmaceutical industry in order to separate the stringent laws that regulate drugs industry from the laws applicable to medical devices.
Medical Device Definition: As per Medical Device Rules 2017,
- Specific devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals which are notified by the government from the time to time under the Drugs and Cosmetics Act, 1940 (“D&C Act”).
- Specific substances intended to affect the structure or any function of the human body which are notified by the government. At present, the substances notified are mechanical contraceptives (eg. condoms, intrauterine devices, tubal rings) and disinfectants.
- Surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant;
- Substances used for in vitro diagnosis (referred to in the 2017 Rules as “In Vitro Diagnostic Medical Device”)
- All substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals.
Classes of Medical Devices:
Four categories based on their risk type
Class A – low risk devices
Class B – low-moderate risk devices
Class C – Moderate high risk Devices
Class D – High Risk Devices
Assessment Authority as per class of Devices
Application for manufacture of Class A or Class B medical device: State Licensing Authority
Application for manufacture of Class C or Class D medical device: Central Licensing Authority (DCGI)
Unique Features of New Medical Device Regulations, 2017
- Single window clearance – Single Online Portal
- Product standards for medical devices – Bureau of Indian Standards (BIS), y International Organisation for Standardisation (ISO), International Electro Technical Commission (IEC), any other pharmacopoeia standards, validated manufacturer’s standards can also be used.
- Rationalization of the timelines required for obtaining licenses required to market medical devices
- The licenses granted under the 2017 Rules are perpetual- meaning they will continue to be valid unless they are suspended, cancelled or surrendered.
- Single License for Registration & Import
- New thresholds for residual shelf life of imported products has been set
Get more information on Medical Device Regulations, 2017 with following links:
Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017, sub-rule (3) of rule 4 of classification of the medical devices and in vitro diagnostic medical devices, Appendix -1 – Reg. Download link http://www.cdsco.nic.in/writereaddata/classdf.pdf
Medical Devices Adverse Event Reporting Form: http://www.cdsco.nic.in/writereaddata/MDadverseevent.pdf
Grouping Guidelines for Medical Devices Applications, 16th March, 2018
List of Notified Bodies registered with CDSCO under MDR, 2017 to carry out audit of manufacturing site Dated: 4th May 2018
Finalization of audit fees of notified bodies under MDR 2017
Essential Principles for Safety & Performance of Medical Devices
Frequently Asked Questions on Medical Device Rule, 2017
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