'New Medical Devices Rules Would Usher In Rejuvenated Regulated Atmosphere'

Suresh Kumar, Senior VP, Product Services TÜV SÜD South Asia, in an interaction with Viveka Roychowdhury, opines that the medical devices industry will receive an exponential boost once regulations are in place

- Viveka Roychowdhury

TÜV SÜD was the first independent certification firm in India to receive an accreditation from National Accreditation Board for Certifying Bodies (NABCB) to grant certifications for ISO 13485 & ICMED Schemes. What is the certification process? Does it involve site audits, etc.? What are the parameters required for such certifications? How many such certifications have been granted so far? And what are the costs involved for manufacturers to obtain, maintain and renew such certifications?

Medical device manufacturers can apply to TÜV SÜD for ISO 13485 and ICMED schemes to obtain certifications that indicate their products comply with regulations for domestic use and exports. The initial certification process entails onsite documentation and compliance audits. Once the organisation meets the quality requirements, it is awarded a certification for three years. The validity of the certification is subject to the successful completion of announced surveillance audits in the following two years. In ICMED schemes, surveillance audits are conducted spontaneously. Since this is a comparatively new accreditation, we have a considerable number of certifications that are in the pipeline for final closure. The costs for obtaining these certifications are commensurate with global standards and consists of elements such as annual certificate license and certification body review services.

TÜV SÜD is also part of the Medical Device Single Audit Programme (MDSAP), which is aimed to help manufacturers get their devices into multiple global markets through a single audit. MDSAP was slated for official implementation from January 2017. What is the update on this? What is the response?