The medical devices will be under licensing regime soon, CDSCO now released a draft guidance document on post market surveillance, performance evaluation report, external evaluation and In vitro Diagnostic medical Devices in the country. The IVD Division of CDSCO called for suggestions from interested people within 30 days on proposed guidance. These rules are applicable to any individual, or for companies who want to sell, supply, exhibit, promote or distribute IVDs or medical devices in India. The intention behind the CDSCO Draft guidance is to protect public health by monitoring safety & efficacy of IVDs in India.
CDSCO draft guidance of Stability studies will help manufacturers in preparing pre-marketreview document for Class C and Class D IVDMD. When a manufacturer of medical device /importer applies for theCDSCO manufacturing licenseorCDSCO import license,They need to be ready with pre-market review documents for Class C and Class D along with application. This document contains information about the shelf life and shipping studies of the product. The team of Operon Strategist assists importers and manufacturers in making this document which help them in getting the test license, so that obtaining the manufacturing /import license becomes easy.
Under the MDR, 2017, to obtain license for manufacturing or importing Class B, C, or D IVDs, the applicant needs to submit a copy of performance evaluation report along with the application. Our team helped manufacturers and importers to create this report. CDSCO draft guidance gives an overview on performance evaluation and external evaluation of IVDMD. The licensing authorities may require PER (performance evaluation report) for
- HIV
- HBV, HCV
- Cancer
- Blood grouping reagent
- Pneumonia
- Dengue
- Tuberculosis
上面提到的几个19中vitro diagnostics for which the PER is required. The healthcare decisions mostly rely on information provided by clinical laboratory tests. These decisions profoundly influence diagnosis and management of the patient and will be influenced by the risk to the patient of incorrect results from IVDs “said the CDSCO draft guidance document.
The guidance documents for performance evaluation explain various terms such as
- Testing facilities
- Laboratory testing
- Cost effectiveness
- Storage standards of the product.
- Disposal of samples and retention of reports.
CDSCO draft guidance or updates having intentions for the betterment of the services and safety of the patients, but these guidance or draft documents may confuse the manufacturer or importer and they need an experienced medical device consultant to resolve the ambiguity. As amedical device regulatory consultant, we are solving issues related to regulatory updates, manufacturing license, import license and provide guidance for the documents so that they easily get the license. For more medical device regulatory updates you can download ourNewsletter.Feel free to contact us or to ask any questions related to this.
References:
