Last Updated on December 31, 2023 by The Health Master
Download the draft guidance documents, links are given below: As part of its efforts to bring all the medical devices under the licensing regime by next year, the Central Drugs Standard Control Organisation (CDSCO) has released draft guidance documents on stability studies, post-market surveillance, performance evaluation, and external evaluation of In Vitro Diagnostics Medical Devices (IVDMD) in the country.
The IVD Division of CDSCO, releasing the document on July 7, called for suggestions from interested parties on the proposed guidance in writing within a period of 30 days.
The guidance document for stability studies is for manufacturers in preparation of a pre-market review document for Class C and Class D IVDMD import or manufacturing license applications, intended to aid manufacturers in the preparation of scientific information to be provided in support of claimed shelf life, in use stability and shipping studies for Class C and D IVDMD applications and post-approval change applications filed pursuant to the Medical Devices Rules (MDR), 2017.
The draft guidance document integrates global regulatory practices within the MDR, 2017 licensing requirements and CDSCO is looking to adopt the use of this guidance for pre-market license applications and post-approval change applications.
Once implemented, all pre-market in vitro diagnostic device license applications are expected to be prepared as specified in the guidance.
The guidance document on post-market surveillance of IVDMD has been prepared to facilitate and strengthen the reporting of adverse events attributable to IVDMD in India and to facilitate access to safe, appropriate, and affordable in vitro diagnostics of good quality in an equitable manner, said the regulator.
The document provides guidance on the requirements of reporting adverse events for IVDs falling under Class C and D such as those for detection of HIV, hepatitis, syphilis, malaria, dengue, cancer markers, cardiac markers, etc., Point of Care tests (POCTs) or Home-use IVD medical devices such as glucometer and strips among others.
The guidance details the method of identifying complaints, reporting verified complaints, responsibilities of manufacturers and importers, corrective and preventive actions, types of product recall and recall strategy, with formats of the recall notice, IVD complaint reporting form, and Field Safety Corrective Action Notification, among others.
Under the MDR, 2017, for the grant of license to manufacture or import Class B, C, or D IVDs, the applicant is required to submit a copy of performance evaluation reporting along with the application, and the CDSCO has now released the draft guidance for an overview on performance evaluation and external evaluation of IVDMD.
An earlier guidance document was issued in August 2018, with the list of laboratories for such tests to be conducted, and later issued updated lists in August 2019, February 2020, and May 2022.
The licensing authorities may require the performance evaluation report for almost 19 in vitro diagnostics, including:
- HIV,
- HBV,
- HCV,
- Blood grouping reagent,
- Cancer,
- Tuberculosis,
- Malaria,
- Dengue,
- Chikungunya,
- Syphilis,
- Typhoid,
- Influenza,
- ToRCH (Toxoplasma Gondi, Rubella virus, Cytomegalovirus, Herpes simplex virus),
- Chlamydia,
- Pneumonia,
- Methicillin-resistant staphylococcus aureus,
- Enterovirus,
- Sexually transmitted agents
- Marker for congenital disorders.
IVDs differ from other medical devices as they perform their function outside of the body on specimens taken from the human body, and this must be taken into consideration to understand the performance evaluation at independent or external laboratories.
The risks and benefits these devices pose are related to impact on patient management, rather than direct contact between the device and the patient.
“A significant percentage of all healthcare decisions rely on information provided by clinical laboratory tests and these decisions can profoundly influence diagnosis and management of the patient and will be influenced by the risk to the patient of an incorrect result from the IVDs,” said the CDSCO in the guidance document.
The guidance for performance evaluation defines various terms and elaborates on the:
- Testing facilities,
- Responsibility for testing laboratory,
- Safety measures,
- Procedure for dispatch of sample to testing laboratory,
- Procedure to be adopted by the testing laboratory on receipt of sample,
- Storage standards of products,
- Laboratory testing,
- Recording test results and interpretation of test results,
- Acceptance criteria and standards,
- Cost-effectiveness,
- Training and supervision,
- Turnaround time for testing,
- Retention of samples and report,
- Administrative review,
- Disposal of samples and retention of reports.
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