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In the preceding five years, the medical device industry in India has undergone significant changes, particularly on the regulatory front. Still at a transitory phase, the medical device industry
To begin with, the Medical Devices Rules, 2017 (“MDR”), were enacted to regulate and standardise medical devices in India, among other things. The rules came into effect from January 2018 and were soon followed by another pair of notifications by Ministry of Health and Family Welfare (“MoHFW”) dated February 11, 2020, i.e. a new definition of medical devices in pursuance of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 (“DCA”) & The Medical Devices (Amendment) Rules, 2020.
- The idea of the new definition is that if a device, including software or accessories, is intended by its manufacturer to aid in any of the below -mentioned purposes, it will fall under the definition of “medical device” and be covered by the Medical Device Rules.
- Furthermore, this also bought a new range of medical devices under the purview of Medical Devices Rules (particularly due to extensiveness of treatments, diagnosis, and monitoring).
Legal Definition of a Medical Device
Medical devices are classified as drugs under the DCA.
- According to Section 3(b)(iv) of the DCA, drugs include
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 may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board
- The new definition as per the notification dated February 11, 2020 states,
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
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.
- Section 3(b)(iv) of the DCA- Provides for definition of drugs vis-à-vis medical devices
- MDR (notified on 31 January 2017)- provides for rules & regulations regarding manufacturing, sale, import and labelling of medical devices.
- MoHFW vide the second notification (No. S.O 648[E]) dated February 11, 2020 in pursuance of Section 3(b)(iv) notified new medical devices to be considered as drugs as per Section 3(b) of DCA.
- Medical Devices (Amendment) Rules, 2020 (Notification No. GSR 102 [E]) stipulate for registration of newly notified medical devices.
- Medical Devices (Amendment) Rules, 2022 (Notification No. GSR 19 [E])- stipulates for provisions where a provisional registration number can be generated.
Eligibility to apply for the Medical Device Registration
- Domestic Manufacturer
- IAA (Indian Authorised Agent) of the Manufacturer
- Any foreign enterprise holding Indian Subsidiary
Procedure for Registration of Medical Devices
- In 2020, the MoHFW brought up an amendment in the MDR. (See above), whereby it stipulated that all importers and manufacturers of medical devices other than the 37 categories of medical devices notified earlier [Rule 19A (1)] shall be registered with the Central Licensing Authority through an identified portal facilitated by the Central Drugs Standard Control Organisation (CDSCO). [Rule 19A (2)].
- The Applicant has to sign up and create an account. A guide explaining the complete online registration process is mentioned here.
- The registration will be on a voluntary basis for the first 18 months and compulsory thereafter. [Proviso to Rule 19A (2)]
- If the New Device is a Class A or Class B device, it will be exempt from the MDR for 30 months from the date the amendment notification regarding registration goes into effect, and for 42 months if the New Device is a Class C or Class D device (“Exemption Provision”). [Annexure to the 8th Schedule – S.N 7]
- Details to be uploaded by the manufacturer and importer for registration of new medical devices on the Online System for Medical Devices (“OSMD”)
Details of Applicant
Name and address of entity manufacturing the medical device and the name and address of the manufacturing site.
Name of the entity importing the medical device and specification and standards of that medical device,
Details of Medical Device
– Generic Name
– Model Number
– Intended Use
– Class of Medical Device
– Material of Construction
– Dimension (if any)
– Shelf Life
– Sterile or Non-Sterile
– Brand Name (Registered under the Trademarks Act, 1999)
SAME DETAILS AS THE MANUFACTURER HAS TO DISCLOSE
Certificate of Compliance
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
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 and a free sale certificate from the country of origin.
Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.
Undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.
- After uploading the above mentioned documents in the OSMD, facilitated by CDSCO, by the applicants, a registration number or basically a file number containing your details will be generated following which, the manufacturer as well as the importer may mention the registration number/provisional registration number (“number”) on the label of the device depending on case to case basis, till 31st May 2022, after which such it would be mandatory for all registration holders i.e. with effect from 1st June, 2022 onwards.
- The Medical Device (Amendment) Rules, 2022 creates a provision for getting a number through submitting an undertaking on or before the 28th February, 2022, that the applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in 19B (2)(iii). The number shall be valid up to 31st May, 2022 or the date on which such applicant obtained the desired ISO certification.
An explanation has also been added in the said rule which mentions that the number will cease to exist without any notice if such ISO certification has not been obtained by the applicant before 31st May, 2022.
- Issuance of ISO Certificate- ISO certificate is industry standard to measure the quality management system of a medical device. ISO 13485 is the industry standard number for medical devices. It is issued or certified by a certification body affiliated to the National Accreditation Board for Certification Bodies (NABCB) or the International Accreditation Forum (IAF) to the manufacturer of medical devices. Now the Government has come up with the ICMED 13485e. The Indian Certification of Medical Devices which is voluntary quality certification scheme for medical devices in India. The intention is to provide the consumers the best quality and superior standards of medical devices.
Author- Swayam Samarth- Intern at Khurana & Khurana & Co- Author- Ajay Kacher, Legal Associate at Khurana & Khurana, Advocates and IP Attorney, in case of any queries please contact/write back to us via email firstname.lastname@example.org.