Currently, India has only just begun to address medical devices as a separate regulatory category. Generally, regulation of medical devices is only conducted by officially classifying certain devices as “drugs” and subject to drug laws. Since March 1, 2006 there have been ten additions to this list of medical devices classified as “drugs,” but the government has only recently begun to develop regulations for these medical devices.
The ten medical devices include:
- Cardiac stents
- Drug eluting stents
- Catheters
- Intra-ocular lenses
- IV cannulae
- Bone cement
- Heart valves
- Scalp vein sets
- Orthopedic implants
- Internal prosthetic replacements
The Central Drug Standards Control Organization, India’s chief drug regulator, established a sub-committee to determine licensing rules for these ten medical devices in December 2006. However, this sub-committee has only now been made responsible for establishing standards for manufacturing, qualification of technical staffs, and establishing testing processes for each device. Currently, the only part of Indian regulations that have been adapted for these devices are the actual forms for registration.