What You Should Know About Medical Device Registration In India?by Divya S. Content Writer
With the invent of more and more devices, the rules for its regulations have been changed in India. As India is playing a major role in marketing of these devices in Asia, and beyond, regulating Medical Devices poses a real challenge, upon implementation of the Medical Device Rules, 2017.
In this article we will discuss about how to register a new Medical Device Registration India and how to carry out import of cosmetics.
Today, India’s medical device sector is dominated by multinational companies, which is evident from the fact that India relies on imports of medical devices (about 75-80% of the sales are generated by imported medical devices) to supply its healthcare system.
Thus, because of the increasing opportunities, the regulations are becoming stricter and companies are facing more complications. This process can be made simpler and manageable with the assistance and help of consultants.
CliniExperts serves as an authorised Indian agent and provides end to end solution right from product classification and its respective documentation submission, labelling requirements, follow ups and obtaining the permissions.
There are more than 500 Medical Device Regulation India and in vitro diagnostic medical devices which are required to be registered before they are intended for marketing in India, all other requires a no objection certificate from DGCI, for selling. This no objection certificate (NOC) states that the product doesn’t requires registration and is free for import in India.
The regulatory bodies responsible for Medical device registrations are:
· The Central Drug Standards Control Organization (CDSCO) under Directorate General of Health Services in Ministry of Health and Family Welfare, Government of India is the National Regulatory Authority (NRA) responsible for approval of manufacturing, import, conduct of clinical trials, laying down standards, sale and distribution of medical devices through enforcement and implementation of the Medical Devices Rules, 2017.
· The Drug Controller General of India (DCGI) shall be the Central Licensing Authority responsible for enforcement of rules in matter pertinent to import of all Classes of medical devices.
· Drugs & Cosmetic Act 1940 & Rules 1945 are responsible for manufacturing, import, sale and distribution of medical devices.
· The State Drugs Controller serves as the State Licensing Authority (SLA) and shall be the competent authority for enforcement of the rules relating to the manufacture of Class A or Class B medical devices and the sale, stocking and exhibition of medical devices and other related functions.
Classification of medical devices
Class A – Low Risk like thermometers, tongue depressors
Class B – Low-moderate Risk like hypodermic needles, suction equipment
Class C – Moderate-high risk like lung ventilator, bone fixation
Class D – High Risk like heart valves, implantable devices
Process of medical device registration in India:
For Class A & B Medical devices,State Licensing Authority (SLA) shall be the competent authority for enforcement of the rules relating to the manufacture sale, stocking and exhibition of medical devices and other related functions.
For Class C and Class D high-risk medical devices, Central Licensing Authority (CLA)oversees the clinical investigation and clinical performance evaluation of medical devices and has other related functions.
If the manufacturer intends to manufacture a predicate medical device, the manufacturer must receive approval from the CLA before applying to the SLA.
For import or manufacture of new medical device (without predicate), an application for grant of permission for such medical device after completion of its clinical investigation shall be made to the Central Licensing Authority in Form MD-26 accompanied with fee either by an authorised agent in case of import or a manufacturer.
DGCI may evaluate the application received along with fees and may require clinical testing of the device either in India or abroad.During the whole process, DGCI may make a visit to the manufacturing unit. After review of the application. it sends anenquiry letter to applicant for further response.DGCI may sometimes require a technical presentation and then approves the application.The whole process of registration may take about 9-18 months if there exist no clinical trials.
In India, one of the largest industries is the cosmetic industry that is spreading in a very speedy rate and its size is more than that of US and Europe. Because of this to assure that the products are safe for using Ministry of Health and Family Welfare in India has introduced many rules in which a registration certificate is needed for importing cosmetics in India. So, if you have any plan to initiate a cosmetics business in India, then there are specific guidelines you are required to follow.
The manufacturer of the cosmetics should have a registered office in India.The cosmetics should be registered with Central Drugs Standards Controller India under Ministry of Health and Family Welfare. Application form is filled up and submitted to concerned authority both in electronic and hard copy.The registration certificate is issued well within 6 months after submission and the certificate is valid till 3 years after which renewal is required for continuing the business. Some of the documents required are a valid import export code, payment proof of fees, all details about cosmetics and the manufacturing license, list of countries where the product has permission. All details about the ingredients of the cosmetics, and methods of testing and product specification.
Thus, whether it is medical device registration or Cosmetic Import India you are required to follow certain guidelines.
Created on Apr 15th 2019 03:04. Viewed 222 times.