Addendum to FAQ on Medical Devices Rules, 2017

Addendum to FAQ on Medical Devices Rules, 2017

The CDSCO – Medical Devices Division has released an essential document addressing frequently asked questions on medical device regulations. This update covers critical aspects such as testing, licensing, labeling, and compliance requirements under IMDR-2017.

Biocompatibility Testing

• Required for devices in contact with the human body (ISO 10993).
• Existing data may be accepted under specific conditions.
• Additional tests are needed for varying invasiveness levels.

Sterilization & Parametric Release

• Validation is mandatory before initial use.
• Compliance with BIS/ISO standards is required.
• Parametric release allowed for validated processes.
• Routine revalidation ensures continued compliance.

Expiry/Shelf Life Labelling

• Non-sterile medical devices do not require an expiry date.

Licensing & Registration Updates

• Fresh licenses required for company constitution changes.
• Existing licenses remain valid until new issuance.

Import License & Manufacturing

• Separate applications required for multiple manufacturing sites.

Sterile & Non-Sterile Device Labelling

• Non-sterile devices must include clear labelling & usage instructions.
• Sterile devices must specify sterilization methods & sterility assurance.

Wholesale License Exemption

• Class A (non-sterile, non-measuring) devices are exempt.

Regulatory Pathway & ISO Certification

• MDR-2017 regulatory pathways available on the CDSCO website.
• ISO 13485:2016 certification is NOT required for a manufacturing license.

Brand Name in Import Applications

• Must be registered under the Trade Marks Act 1999 & included in the Free Sale Certificate.