Upon the expiry of these time periods, all provisions of the Medical Devices Rules 2017 will apply to the respective devices
To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry notified medical equipment used on humans or animals as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020.
The ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices.
The aim is to regulate all medical devices so that they meet certain standards of quality. Besides, it will also make medical device companies accountable for the quality and safety of their products, a senior official said.
“In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, 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 with effect from the April 1, 2020,” the notification read.
Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO).
All devices, including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others, will be regulated under the legislation.
At present, only 23 categories of medical devices are regulated under the law.
The country’s highest advisory body on technical issues related to drugs and medical devices, the Drugs Technical Advisory Board (DTAB), had in April 2019 recommended that all medical devices should be notified as drugs under the Drugs and Cosmetics Act.
Once the notification is issued, the CDSCO will be the nodal authority to investigate complaints related to the quality and safety aspects of medical devices and can suspend the registration or cancel licences of firms.
More so, the ministry, through a gazette notification, released Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices.
The medical devices referred shall be registered with the central licensing authority via an online portal established by the CDSCO for the purpose.
The manufacturer of a medical device or any person who imports any medical device will have to upload the information related to that medical device for registration on the ‘Online System for Medical Devices’ established by the CDSCO for this purpose.
Further, the notification also provides timelines for medical devices that will be notified under the Act with effect from April 1 — 30 months for low and moderate-risk devices (Classes A and B), 40 months for moderately high and high-risk devices (Classes C and D).
Upon the expiry of these time periods, all provisions of the Medical Devices Rules 2017 will apply to the respective devices.
While this is a positive step, as per the timeline, it will still take a long time before many higher-risk devices are regulated, said Malini Aisola from the All India Drug Action Network.
Consumer groups remain sceptical about how the CDSCO’s current ability to regulate devices under the wider scope. We are particularly wary of the CDSCOs competence, expertise and most importantly its commitment towards patient safety given its dismal track record, she said.
“We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients’ safety. These may include guidelines for the approval of devices including clinical investigation requirements, oversight of marketing and promotion, putting in place a robust and functioning system of adverse event reporting accessible to the public, rules for voluntary and statutory recalls, and patient compensation scheme,” Aisola added.
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