Device Trial Regulations
India has focused primarily on drug regulations and establishing a drug regulatory framework. Although this infrastructure has been in place for many decades, India has just begun to address medical devices as a separate regulatory category.
Generally, medical device regulation consists of officially classifying certain devices as “drugs” and applying drug laws to them.
Since 1 March 2006, 10 medical devices have been classified as drugs and added to this list, but the government has begun developing specialized regulations for these devices.
The Central Drug Standards Control Organization (CDSCO), India’s chief drug regulator, established a subcommittee to determine licensing rules for these 10 medical devices in December 2006. The ten devices were:
- Cardiac stents
- Drug-eluting stents
- Catheters
- Intraocular lenses
- IV cannulae
- Bone cements
- Heart valves
- Scalp vein sets
- Orthopaedic Implants
- Internal prosthetic replacements
Recently, this subcommittee was given the responsibility of establishing standards for manufacturing, technical staff qualification and testing processes for each device.
The central government has recently drafted legislation to ensure quality control of vital lifesaving medical devices such as endoscopes and pacemakers.
Medical Device Trial Regulatory Requirements: For conducting the medical devices clinical trials, government has set certain standards regulations.
The following clarifications are required to conduct the medical devices clinical trials in India
- Under the provisions of drugs and cosmetics rules, for registration of medical devices in India, a certificate for free sale issued by the Health Ministry/National regulatory Authority is required.
- Approval for manufacture and free sale from the regulatory authorities of the respective countries is to be submitted like USFDA/TGA Australia/Health Canada/ Ministry of Health, Labour and Welfare Japan or CE Certification is to be submitted.
- For conducting a clinical trial of a device already in use in another country, trial record of 100 days is required to be submitted to the regulatory authorities of India.
- Any change that may involve change in design / change in composition or any other change in the medical device requires approval by DCGI.
- Clinical trials of medical devices must be in compliance with the Food and Drug Administration (FDA) informed consent and Institutional Review Board (IRB) regulations.
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