The Indian Government has made many changes in the rule of selling, manufacturing, importing and registeringof medical devices in India. The main object of this new rule is to simplify and to ensure the high safety and performance of medical devices in India.
The Central Drugs Standard Control Organization (CDSCO) has recently released a new Frequently Asked Questions (FAQ) document to help clarifying thequestions regarding the India’s Medical Device Rules 2017 (Effected from January 2018). This FAQ describes about the various regulatory as well asmarketing related questions like the registration renewal, revised NotifiedMedical Device listing, license retention fee etc… CDSCO has released this FAQ document for creating public awareness about the new Indian Medical DevicesRegulation.
The following summarizes some significant issues covered in the FAQ:
- In case a manufacturer changes their Indian Authorized Agent/License holder then it’s necessary to obtain a fresh license from CDSCO under the Form MD-15
- If the classification of a product being imported is different in GHTF countries from the classification in India then the higher class of Medical device will be considered.
- For companies who were submitted their applications prior to 1.01.2018, but have yet to receive final result from CDSCO, will need to pay balance application fee and re-apply in new online registration portal SUGAM
- A company may pay a single import license fee for a grouped submission so long as all devices in that group share similar technology, intended use and product specifications.
- Post Marketing Surveillance (PMS): Authorized Indian Agent/License holder is responsible for managing post-market surveillance activities and reports.
- Inclusion of additional products on existing licence can be obtained by paying additional fees and submitting documents as per current Medical Device Rules 2017.
The introduction of the Medical Devices Rules, 2017 gives industry a regulatory framework in their business systems involved with manufacturers, exporters, importers, distributors,sellers of Medical Devices. To know more about new Medical Device Regulations please visit our Blogs.