The Government of India is planning to develop an in-depth regulatory framework for medical devices and IVDs registration. These are regulated under the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of Health and Family welfare of India.
The regulatory structure for medical devices in India is under the Drugs and Cosmetic Act of 1940, and Drugs and Cosmetic Rules of 1945. Currently there are 22 regulated / notified medical devices in India under the Drugs & Cosmetics Act.
Registration of Devices (notified) gives manufacturers regulatory approval certification by the CDSCO body in India. Non notified devices do not require CDSCO registration and regulatory approval and can be imported into India according to formal customs rules.
CDSCO Recent Online Portal “SUGAM” Updates:
Online Portal “SUGAM” to File Applications for Various Services:
In January 2016, CDSCO,India has implemented an online portal “SUGAM” to file applications for various services including application for registration certificate and import license application for notified medical devices . Notice dated 15th February 2016 said, it is required that all the applicants should submit the applications online along with the hard copies for registration/regulatory approval. “The on-line services have been initiated by Central Drugs Standard Control Organization (CDSCO-India) for quick delivery of services. It is proposed to receive all new applications for obtaining import licenses and registration certificate of drugs by the way of online receipt from 15.02.2016. In the interest of smooth transition to the e-Governance system applications for obtaining registration certificate of drugs in Form 41 , which were received prior to 15.02.2016 in hard copies and which are under processing at various stages at CDSCO (HQ), may also be made online through CDSCO website (Sugam online application) to take fmiher action in the matter, from the stage of process of application.”
DCGI to Dispose of Applications for Licenses, Approvals if Clarifications Not Submitted in 45 days:
The notice dated on 13th July 2016 said, Drug Controller General of India (DCGI) to dispose of applications for licenses/registration approval, if clarifications not submitted in 45 days. ”It is proposed that in cases where an applicant fails to submit the requisite clarification to CDSCO with 45 days of seeking the information and does not seek extension for submission of such information, it will be presumed that the applicant does not intended to pursue its application further and it would be disposed of based on the merit of the application.”
CDSCO Issued Public Notice Regarding Online portal SUGAM:
CDSCO recently issued Public Notice regarding online portal SUGAM Dated 08.08.2016. “In the first phase, filing of applications for import and registration of drugs, Medical Devices were launched. Now, the service is being extended to online submission of CT applications. In this regard, it is decided to convene a meeting of all stakeholders i.e. firms involved in applications of CT NOC on 101 August, 2016 at 11.30 AM in FDA Bhawan, Kotla Road, New Delhi. It is also proposed to conduct live demonstration on software and input I suggestions may be provided by the stakeholders on the same during the meeting. It may be noted that there should not be more than two representatives from each associations due to space constraints. “
Online Submission of Applications for Grant of NOC for BA/BE Studies for Export Purpose:
Notice dated 22.8.2016 said, “Now the service is being extended to online submission of applications for grant of NOC for BA/BE studies for export purpose. In this regard, it is decided that applicants seeking NOC for BA/BE studies for export purpose should apply online w.e.f. 13.09.2016. The applicants are required to do registration by themselves prior to the submission of application. No hard copy of application will be received-from 13.9.2016 for grant of NOC for BA/BE studies for export purpose.”
No Other Third Parties can Interact with the Government for the Application:
Notice dated on 23 August 2016 said, the company /Indian agent who have applied can only interact with the government. No other third parties can interact with the government for the application/registration process.” In the light of SUGAM online portal initiatives, CDSCO would like to encourage direct submission and interaction by the applicants. It would be appropriate to ensure that canvassing through third parties in any form shall be avoided for preventing miscommunication.”
GSR 640 (E) Dated 29.06.2016 Regarding Schedule – MIII – Requirement of QMS for Medical Devices:
In Gazette notification, the new regulatory aim is to bring India’s requirement in compliance with International environment and also in regulatory. “GSR 640 (E) dated 29.06.2016 regarding Schedule – MIII – Requirement of Quality Management System for Notified Medical Devices and IVDs.”
Health Ministry Includes Coronary Stents in NLEM-2015 After Accepting Recommendations of Expert Panel:
CDSCO notice dated 19.7.2016 is for “The Union health ministry has accepted the recommendations of an expert panel constituted to examine the issues relating to the essentiality of coronary stents and has decided to include coronary stents in the NLEM 2015 with immediate effect.”
Future:
Government Issues Draft Medical Devices Rules 2016; Introduces ‘Quality Management System’ for Notified Medical Devices in Place of Schedule M:
- A new medical device regulations will be implemented by CDSCO notice dated 12.7.2016. The Health Ministry issued a set of new guidelines to define and also an regulatory of medical devices as a separate category. These new guidelines will be finalized in consultation with Association of Indian Medical Device Industry and will be issued by the Ministry. This will make medical device regulatory powerful for both the manufacture and importation of medical devices.
- The revised Draft Medical Devices Rules 2016, introducing the ‘Quality Management System’ mandatory for notified medical devices and in-vitro diagnostics in instead of the Schedule M which will now be applicable to pharmaceuticals products only. “As per the new Rule, the licensee of pharmaceutical products shall comply with the requirements of ‘Good Manufacturing Practices’ (GMP) as laid down in Schedule M and the licensee of medical devices and in-vitro diagnostics shall comply with the requirements of “Quality Management System” as laid down in Schedule M-III.”
