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Public consultation on the control of surgical instruments and appliances draft regulations 2018

Thursday, 10th May 2018

 Public consultation on the control of surgical instruments and appliances draft regulations 2018
Introduction

The National Drug Authority Invites feedback from the distributors and healthcare professionals as well as consumers and the general public on the proposed control of surgical Instruments and appliances draft regulations. A copy of the draft regulation is available at this Link.  All feedback should be sent to bkitimbo@nda.or.ug by 30th May 2018.

Background

Section 64 (g) provides for  making regulations for better carrying into effect the provisions of the act --regulate, restrict or prohibit importation ,sale or advertising of surgical instruments and appliances. NDA working in collaboration with stakeholders over the past few years has been laying the foundation for the launch of a regulatory framework for surgical instruments and appliances.

NDA has drawn up a proposed regulation of surgical instruments and appliances and now seeks input and views from distributors, healthcare professionals as well as consumers, and general public to further improve and refine the regulation before it is formalized.

In drafting the regulation, NDA has considered a measured approach to safeguard public health without restricting access to essential and new technologies.


Controls for Import, Sale and Advertising of Surgical Instruments and appliances

The proposed framework comprises of the following key fundamentals:

Licensing

The licensing controls are aimed at regulating the supply chain and ensuring that only bona fide persons are engaged in dealing with surgical instruments and appliances.

Control on advertising

NDA sets out circumstances under which advertising and promotion is permitted to curb any false or misleading advertising claims inconsistent with safety, quality and intended use of the products as registered.

Registration

All surgical instruments and appliances shall be registered before sale or distribution in Uganda

Unregistered surgical instruments and appliances

Access to unregistered surgical instruments and appliances is provided for under emergency situations.

Feedback Required

The proposed regulatory framework remains a work in progress and NDA welcomes any input or feedback from all stakeholders.

The draft regulations are subject to changes depending on the outcome of this consultation


National Drug Authority

May  2018


Downloads
  • List of surgical instruments and appliances  download

  • Form consultation  download

  • NDP & A (Surgical Instruments and Appliances) Regulations 2018- May version download