Skip to content
srilawsby aturio
As enacted
Contents

Part IV · General

68. Medical Devices Evaluation Committee

Official English translation. Where it differs from the Sinhala or Tamil text, the Act itself says which text prevails.

(1)

There shall be appointed for the purposes of this

Act a Committee which shall be known as the Medical

Devices Evaluation Committee (hereinafter referred to as

“the MDEC”).

(2)

(a)

The principal function of the MDEC shall be to carry out the technical evaluation of the medical devices forwarded for registration and to submit a report in respect thereof to the Authority.

(b)

The report shall specify the benefits, risks attached to such medical devices, and the efficacy, quality, safety, need and cost of such medical devices with pharmacoeconomic analysis where necessary in keeping with the National

Medicines Policy.

Read on from s 69

Part V

General

Read on from Part V

Part VI

Rules and Regulations

Read on from Part VI

Part VII

Repeals and Transitional Provisions

Read on from Part VII

Part VIII

Interpretation

Read on from Part VIII