Directive on Health Technology Product and Equipment 2074 Nepal

The Directive on Health Technology Product and Equipment, 2074 establishes guidelines to regulate the production, import, export, sales, and distribution of health technology products and equipment in Nepal. The directive ensures the quality and safety of these products through proper monitoring and adherence to standards.

Key Points

Objective:
- To assure quality in production, import/export, and distribution of health technology products.
- To establish a framework for monitoring, inspection, and adherence to international standards.
Scope:
- Applies to products and equipment listed in Schedule-1, including medical devices, diagnostic tools, laboratory equipment, nutritional supplements, and other health-related products.
National Standards:
- Standards are based on WHO guidelines or existing international norms.
- Products must meet these standards to be produced, imported, or sold in Nepal.
Registration Requirements:
- Mandatory registration of health technology products and sales centers before distribution or operation.
- Certificates must be renewed annually.
Recommendation Letters:
- Required for establishing industries, exporting, or importing products.
- Applications follow formats outlined in specific schedules.
Prohibited Activities:
- Production or import of substandard products.
- Importing used, repaired, or rebuilt equipment.
Monitoring and Inspection:
- The Department of Drug Administration (DDA) oversees compliance through routine inspections.
Pricing and Fees:
- Maximum retail prices can be set by the DDA.
- Testing and certification costs are borne by applicants.
Testing Facilities:
- Testing is conducted by:
  - National Bureau of Standards and Metrology.
  - National Medicine or Public Health Laboratories.
  - International laboratories if local facilities are unavailable.
Penalties:
- Violations of the directive result in action under existing laws.