How to start a Medical Device Business in India

1. +91 7672005050, +91-11-28081765 contact@cliniexperts.com How to start a Medical Device Business in India Summary: In this article, we will discuss briefly the medical device registration process in India and about all new rules and regulations relevant to medical devices prior to their introduction in the Market. Nowadays, health is given much priority in all aspects. The present generation is very much conscious about having periodic checkups and maintaining a good health. This awareness has given an upper hand to the medical equipment business. The healthcare industry is booming like no other field and because of this, Medical Device Regulation India has also become equally complicated. Unlike previous years, nowadays most medical devices are required to be registered and need approval for business. Classification of medical devices in India. •The New rules has classified 462 products as Medical Devices and 250 products as IVD. For devices which do not require registration, the manufacturer requires a no objection certificate from the respective licensing authority. In this no objection certificate it will state that the particular device doesn't need any registration and can be easily involved in export and import. Although, till now no formal classification has been done, but a draft regulation outlines the following:

2. +91 7672005050, +91-11-28081765 contact@cliniexperts.com Class A – Low-risk devices like thermometers, tongue depressors. Class B – Low to moderate risk devices like hypodermic needles, suction equipment. Class C – Moderate-high risk devices like lung ventilator etc. Class D- High-risk devices like heart valves, implantable devices. •In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the First Schedule, in the following classes, namely: (i) low risk - Class A; (ii) low moderate risk- Class B; (iii) moderate high risk- Class C; (iv) high risk- Class D. •The Central Licensing Authority shall, classify medical devices, based on the intended use of the device and other parameters specified in the First Schedule of the new MDR 2017. How to Obtain Medical Device Registration India? As we now know that some of the medical devices require registration and some like the non-regulated devices are exempted from registration. But for those devices which requires registration

3. +91 7672005050, +91-11-28081765 contact@cliniexperts.com must do so with the DCGI (Drug Controller General of India) before introducing them in the market. For new Medical Device Registration India, approval from DCGI (Drug Controller General of India) is needed before applying for registration. As soon as the application is received with fees the process of evaluation begins. There may be a requirement of clinical testing and visit of the manufacturing premises by DGCI officials during evaluation. If everything is found to be correct and satisfactory, an approval is awarded to the company. But it is a lonesome process and it may take about 9-18 months for approval even if there are no clinical trials involved. The manufacturer from foreign countries who want to register their devices in India should offer the approval proof in their home market along with certain proof of prior regulatory authorization in the US, Canada, EU or Australian markets, so it can help with the process. Your technical documentation should be reviewed by CDSCO (Central Drugs Standard Control Organization) and after its approval, the registration process finally gets completed. An authorized agent having license to manufacture for sale or distribution or wholesale license for sale or distribution under these rules, shall make an application for grant of import license for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a license. After examination of documents furnished with the application under sub-rule (1) of rule 34 and on the basis of the inspection report, if inspection has been carried out, the Central Licensing

4. +91 7672005050, +91-11-28081765 contact@cliniexperts.com Authority may, on being satisfied, grant license in Form MD-15 or, may reject such application for which reasons shall be recorded in writing, within a period of nine months from the date of application. The person who desires to import medical device under sub-rule (1), shall apply for an import license for test, evaluation or demonstration or training to the Central Licensing Authority in Form MD-16. If the Central Licensing Authority, after such enquiry, if any, is satisfied that the requirements of these rules have been complied, the said authority shall grant a test license in Form MD-17, or may reject the application for reasons to be recorded in writing, within a period of thirty days from the date the application. Medical Device Regulations in India Till date, the medical device regulations India, have formulated so many new attributes that will enhance the medical device sector in India. Like the introduction of a single online portal for the registration process. Furthermore, Audits of the notified bodies that will surely enhance the device quality and alteration in the clinical trial needs leads to innovation of new devices. The central licensing approval authority (CLAA). The CLAA, a branch of the CDSCO, serves as the main regulatory body for medical devices. The CLAA will classify medical devices, and any manufacturer seeking a less stringent classification must send justification to the CLAA. In consultation with an expert panel on medical devices, the CLAA also will set and enforce safety standards, appoint notified bodies to oversee conformity

5. +91 7672005050, +91-11-28081765 contact@cliniexperts.com assessment, conduct post-market surveillance, and issue warnings and recalls for adverse events. All medical devices will undergo conformity assessment procedures to ensure compliance with quality and safety standards before they are allowed on the Indian market. The CLAA will adopt as regulatory standards the Bureau of Indian Statistics (BIS) and International Organization for Standardization (ISO) specifications for quality management systems. To meet these standards, medical devices must be designed and manufactured in a way that achieves their intended purpose and does not compromise patient health or safety. What is the scope of medical devices in India? Thus, we can say that the new medical device regulations in India will surely encourage the country’ manufacturing quality and enhance the business of medical devices in India. Author Bio: Author is an expert in Indian Drug and Medical device regulations with a keen interest in tracking and analyzing new changes in the medical industry.