CDSCO Releases List Of Notified Bodies For Conducting Audits Under MDR-2017
Summary: In adherence to the Medical Device Regulation India, the audit of premises manufacturing drugs is compulsory. It is an important part of the regulation process after drug product registration in India.
The CDSCO or Central Drugs Standard Control Organization recently released a list of notified bodies who will be responsible for auditing the manufacturing premises under the provisions of Medical Device Rules, 2017.
According to the notice, the regulatory authority has registered eight notified bodies, thereby giving them the responsibility to carry out audits of the manufacturing sites of drugs and medical devices in India. The rules came into effect in January of 2018. It covers all matters based on production, import, registration as well as distribution including the post-market surveillance of the medical devices.
According to the rule 12 of the Medical Device Rules 2017, a notified body will be responsible for auditing the manufacturing sites of medical devices belonging to Class A and Class B. They have to scrutinize whether the devices comply with the required Quality Management System and other required standards as per the State Licensing Authority.
DCGI has clearly stated that only those notified bodies can carry out the required auditing of companies who are involved in the production of medical devices. The notified bodies selected must have at least two years of experience along with well-qualified specialists. The registration of those bodies will remain valid until their suspension is granted by the CDSCO.
Following is the list of the notified bodies that can perform auditing of manufacturing companies of medical devices:
- Intertek India Pvt. Ltd.
- TUV Rheinland India Pvt. Ltd.
- TUV SUD South Asia Pvt. Ltd.
- Dnv GL Business Assurance India Private Limited
- BSI Group India Pvt. Ltd.
- BSCIC Certifications LTD.
- TUV INTERCERT SAAR INDIA PRIVATE LIMITED.
- Zenith Quality Assessors Pvt. Ltd.
What roles will these notified bodies play?
The notified bodies are responsible for the proper implementation of the regulation process of the medical devices in India. Solo auditing by the government authorities can lead to more pressure on their workforce. Who already has to manage other tasks like processing of new market applications, granting registrations and post-market supervision. Thus, the notified bodies will act as affiliated official bodies that will enhance efficiency and service quality of the overall procedure.
As per the Medical device rules, those notified bodies listed are the legal authorities responsible for performing the assessments as well as verification of certain special categories of medical devices.
The primary role of these notified bodies is conducting assessments for confirmation like scrutinizing information based on the evidence available and processes offered by medical device manufacturers to estimate the compliance with the safety requirements and the whole performance of the medical devices as required.