This news article deals with the updates in the IVD regulations in India. They have come up with three drafts as follows –
- Draft Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – The CDSCO has issued an article on PMS (Post Market Surveillance) of IVDs in India. It details the adverse event reporting requirements for Class C & Class D IVD’s.
- Overview on Performance Evaluation/External Evaluation of In-Vitro Diagnostic Medical Device (IVDMD) – This details out the performance evaluation for IVD’s
- Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) – This details out the rules where the CDSCO requires proof for the shelf life, Post approval changes etc
To understand the latest regulations on IVD’s, contact Morulaa to know more. You can contact us on admin@morulaa.com or through our website’s contact form.
