Jubaraj Singha
(The writer can be reached at singhajubaraj@gmail.com)
A medical device is an article which is used to mitigate, diagnose, prevent, treat or cure diseases or other conditions. Unlike a pharmaceutical product it achieves its purposes by physical, structural or mechanical action but not with chemical, pharmacological or metabolic action. For example diabetes test strips, ECG machine, MRI machine, stents Intraocular lens, pacemaker including wheelchair etc. It is a product for human use which has a medical purpose. It provides information on diseases, injuries, disabilities, anatomy, physiological or pathological state or provide information through in vitro examination. There are many products though they do not have any medical purposes but included as medical devices. According to the Definition Notification as notified in the Gazette Notification on February11, 2020, the amended definition of "medical devices" under Section 3(b)(iv) of the Drugs and Cosmetics Act, as '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 do 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'.
The primary differences between drugs and medical devices are that drugs are based on chemistry and pharmacology but devices are based on engineering. Drugs may elicit drug interactions if misused but devices may suffer from device malfunctioning. All medical devices must have their principal intended actions which should not be like drug action, for example a drug eluting stent works by opening of artery and then followed by secondary action of restenosis and reduction of inflammation by drugs similarly for a drug eluting disc the primary mode of action is for chemotherapeutic treatment followed by delivery of drugs at the site of action. So the drug eluting stent is regulated as a device whereas drug eluting disc as a drug.
Medical devices are designed and manufactured with a specific and intended purpose i.e. to enhance the patients' quality of life and their safety. To accomplish this, the medical devices must be easy to handle and function as intended by the manufacturer's instructions without compromising the safety of patients, users or patient's clinical conditions. Therefore, medical devices must comply and meet the standards set by the essential principles of safety and performance of WHO. The responsibility towards the medical devices' safety and performance lies with both the manufacturer and the regulatory authority. FDA reviews the medical devices according to the risk to the patients. Higher risk require more clinical safety then lower risk product. Meditronic remains the largest Medical device company in the world. The global medical device market is predominantly controlled by U.S.A. having its share of 40% followed by Europe 25% Japan with 15% and rest of the world including India with 20% share. India is currently importing near about 80% of medical devices from countries like China, USA, Germany, Netherlands, Singapore. The government has taken various steps for production of all medical devices, equipment. Such Schemes are National biopharma Mission, DBT-AMTZ, Med –tech etc. An effort was made to encourage the 'Make in India' drive of the Government of India to acquire licenses for the manufacture of medical devices indigenously. The Central Drugs Standard Control Organization (CDSCO) published the Medical Devices Rules, 2017 which came into force on January 1, 2018 under section 12 of D&C Act. On February 11, 2020, the Ministry of Health and Family Welfare (MoH&FW) issued two notifications in the Indian Gazette – a new definition of medical devices and The Medical Devices (Amendment) Rules, 2020, the latter amends the Medical Devices Rules, 2017, and has been effective from April1, 2020 The MDR, 2017 was further amended in 2020 and come into force on 1st day of April, 2020. These rules were deemed to simplify the regulatory structure to obtain registration and licenses by importers and manufacturers of 'medical devices' which were distinguished for the first time since the Drugs and Cosmetics Act, 1940, was enacted. It introduced risk-based classification system and product standards for medical devices, single window clearance, certain and rationalized timelines for obtaining registration and licenses. It also consolidated requirement of obtaining registration certificate and import license into a single licensed for foreign manufacturers. The standards of quality and safety of medical devices are regulated in India by the Drugs and Cosmetics Act, 1940 (DCA). The scope of DCA is restricted to only those medical devices which are notified by the Government from time to time as 'drugs' (commonly referred to as 'notified medical devices'). The Medical Devices Rules, 2017 ("MDR") had been framed under DCA and it laid down comprehensive quality requirements to be followed by importers, manufacturers, sellers of notified medical devices. The DCA and MDR ensure quality and safety of notified medical devices at all levels of the supply chain by enforcing a mandatory license requirement. All importers, manufacturers, sellers of notified medical devices must obtain a license from the appropriate licensing authority before undertaking any business in notified medical devices. Until February 11, 2020, the Government had regulated or notified 37 categories of medical devices as drugs.
In the Medical devices (Amendment) Rules, 2020, the first major amendment is registration of medical devices by their respective manufacturers and importers. The second is an exemption for the 37 categories of already regulated or notified medical devices from the requirement of registration. The manufacturers or importers of Medical Devices will be required to compulsorily register their medical devices with the Drugs Controller General of India (DCGI) before October 1, 2021. The DCGI has started accepting applications for registration through a online portal called 'Online System for Medical Devices' from April 1, 2020. The Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaint. In case the registrant fails to comply with any of the provisions of these rules, it may after giving the registrant an opportunity to show cause as to why an order for cancellation of registration should not be passed, by an order in writing stating the reasons thereof, cancel the registration number or suspend it for such period as it thinks fit either wholly or in respect of any of the medical devices to which it relates.
All the medical device industries must obtain ISO 13485 certification within the regulatory framework, if not already obtained. The 37 categories of medical devices regulated or notified before the date of MDR Amendment i.e. February 11, 2020, will not be affected by this amendment and therefore will not be required to obtain registration. If an importer or manufacturer of a Medical Device fails to obtain a license until October 1, 2021, then it will have to cease import or manufacture of said medical device until such time the registration is obtained. Manufacture and sale of the devices without a valid license as prescribed under the MDR will result in criminal prosecution which includes imprisonment for not less than three years, extendable up to five years and fine which shall not be less than Rs 1 lakh or three times the value of drug confiscated. The new Rules 2020 are being introduced to ensure that every medical device, either manufactured in India or imported, have quality assurance before they can be distributed or sold in the market. Further, a large number of commonly used medical items including hypodermic syringes and needles, cardiac stents, perfusion sets, catheters, orthopaedic implants, bone cements, lenses, sutures, internal prosthetic replacements etc. are covered under the new rules. It gives a wider scope to test and modify such devices, which fall under the ambit of the new definition, post-introduction upon the relevant market.