How medical device regulation in India has changed than earlier times?

1. +91 7672005050 + 65 31630390 contact@cliniexperts.com How medical device regulation in India has changed than earlier times? In this article, we will discuss the how medical device regulations have changed with time and how new rules and regulations have been introduced by the government of India for device marketing and how medical devices have been classified based on their risk type. There was a high in demand by the medical device industry for new medical device registration Indiathat will enable them to get separated from the pharmaceutical industry. With new regulations, the strict laws that control the drug industry will be separate from the laws that control the medical devices. Thus, in the year 2017 Government of India finally introduced medical device regulation India and it came into effect in the month of January 2018. According to the rule, the specialized devices that are intended for internal or external use for diagnosis, mitigation, treatment

2. +91 7672005050 + 65 31630390 contact@cliniexperts.com or disease prevention in human beings are notified by the government frequently under the D& C act. Then substances that can affect the structure or function of the human body are notified by the government. As of now some of the substances that are notified are disinfectants and mechanical contraceptives. Then some other substances like the surgical dressings, staples, bandages, ligatures, blood component collection bag. Substances that are used for in vitro diagnosis. Classification of medical devices At present, the medical devices have been classified into four categories based on their risk type. Class A are low-risk devices Class B devices ate low moderate risk devices. Class C is moderate high-risk devices Class D devices are high-risk devices. Now let's discuss the corresponding assessment authority for each class of devices.

3. +91 7672005050 + 65 31630390 contact@cliniexperts.com For manufacturing class A or Class B medical devices, the concerned authority is the state licensing authority. All applications are handled by it. Then the application for manufacture of class C and class D medical devices the concerned authority is a central licensing authority. In the year 2017, there was the introduction of single window clearance and single online portal for medical equipment registration. Then for medical device product standards, BIS, ISO or any valid manufacture standards can be used. Timelines rationalization is required for getting the license for marketing the medical devices. The licenses that are granted under regulations 2017 are perpetual which means they will remain valid until and unless they are surrendered, suspended or cancelled. More importantly, the new threshold for the residual shelf life of the imported products has been set. Medical device registration India The earlier manufacturer could easily introduce new medical devices in the market and there was no necessity of registration but since the year 2006, a new medical device must be in

4. +91 7672005050 + 65 31630390 contact@cliniexperts.com compliance with medical device regulations as set by CDSCO. For registration, you have first determined if your device requires registration or not, if yes appoint an authorized India agent and submit the regulatory Dossier form 40. Then get the registration certificate in form 41 and get the import license in form 10 and start marketing in India. After the amendment of the new Medical Device Rules, 2017, the registration certificate and the import license for the medical device is submerged in a single form 15. For this, applicant is required to apply online on SUGAM Medical Device online portal in Form 14 with prerequisite documents. After the successful submission of the required documents, it will take around 4-6 months to get the license in Form 15.