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As enacted
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Part IV · General

72. Authority to give general guidelines for the evaluation

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

(1)

The Authority shall issue general guidelines to the MDEC for the evaluation of medical devices and other related items, submitted to the MDEC.

(2)

(a)

The general guidelines referred to in subsection (1) shall be based on the Good Manufacturing Practices

(GMP) guidelines and other recommendations and guidelines issued or recommended by the Authority.

(b)

The Authority may revise the general guidelines from time to time in order to maintain parallels with internationally recognized standards and practices.

(3)

The MDEC shall take into consideration the efficacy, safety, quality, need and cost of each medical device or related item in the process of evaluation and may consider pharmacoeconomic evaluation where necessary.

(4)

The Minister may make regulations -

(a)

setting out the procedures to be followed, including the specified time limits, for the conduct of respective evaluations;

(b)

to give effect to the Good Manufacturing Practices

(GMP) guidelines and any other applicable guide lines as may be recommended by the Authority;

Read on from s 73

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