Summary: In adherence to the MedicalDevice Regulation India, the audit of premises manufacturing drugs compulsory. It is an important part of the regulation process after drug productregistration in India.
The CDSCO or Central Drugs StandardControl Organization recently released a list of notified bodies who will beresponsible for auditing the manufacturing premises under the provisions ofMedical Device Rules, 2017.
According to the notice, theregulatory authority has registered eight notified bodies, thereby giving themthe responsibility to carry out audits of the manufacturing sites of drugs andmedical devices in India. The rules came into effect in January of 2018. Itcovers all matters based on production, import, registration as well asdistribution including the post-market surveillance of the medical devices.
According to the rule 12 of theMedical Device Rules 2017, a notified body will be responsible for auditing themanufacturing sites of medical devices belonging to Class A and Class B. Theyhave to scrutinize whether the devices comply with the required QualityManagement System and other required standards as per the State LicensingAuthority.
DCGI has clearly stated that onlythose notified bodies can carry out the required auditing of companies who areinvolved in the production of medical devices. The notified bodies selectedmust have at least two years of experience along with well-qualifiedspecialists. The registration of those bodies will remain valid until theirsuspension is granted by the CDSCO.
Following is the list of the notifiedbodies that can perform auditing of manufacturing companies of medical devices:
● Intertek IndiaPvt. Ltd.
● TUV RheinlandIndia Pvt. Ltd.
● TUV SUD SouthAsia Pvt. Ltd.
● Dnv GLBusiness Assurance India Private Limited
● BSI GroupIndia Pvt. Ltd.
● BSCIC Certifications PVT. LTD.
● TUV INTERCERT SAAR INDIA PRIVATE LIMITED.
● Zenith Quality Assessors Pvt. Ltd.
What roleswill these notified bodies play?
The notified bodies are responsiblefor the proper implementation of the regulation process of the medical devicesin India. Solo auditing by the government authorities can lead to more pressureon their workforce. Who already has to manage other tasks like processing ofnew market applications, granting registrations and post-market supervision.Thus, the notified bodies will act as affiliated official bodies that willenhance efficiency and service quality of the overall procedure.
As per the Medical device rules,those notified bodies listed are the legal authorities responsible forperforming the assessments as well as verification of certain specialcategories of medical devices.
The primary role of these notified bodiesis conducting assessments for confirmation like scrutinizing information basedon evidence available and processes offered by medical device manufacturers toestimate the compliance with the safety requirements and the whole performanceof the medical devices as required.
