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As enacted
Contents

Part IV · General

75. Regulation of manufacture, importation, sale and distribution of medical devices

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

(1)

No person shall manufacture, prepare, store, preserve, package or re-pack any medical device without adhering to Good Manufacturing Practices (GMP) and any other prescribed guidelines or conditions.

(2)

No person shall import or distribute any medical device without adhering to Good Distribution Practices

(GDP) and any other prescribed guidelines or conditions.

(3)

No person shall sell any medical device without adhering to Good Pharmacy Practices and any other prescribed guideline or condition.

Part V

General

Part VI

Rules and Regulations

Part VII

Repeals and Transitional Provisions

Part VIII

Interpretation