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srilawsby aturio
As enacted
Contents

Part IV · General

83. Application for Registration of a Medical device

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

(1)

Any person who intends to manufacture or import any medical device shall make an application for the registration of that medical device in the prescribed form to the Authority.

(2)

The application shall be accompanied by the prescribed particulars, the samples of the medical device and the prescribed fee.

(3)

(a)

The Authority shall maintain a register in which every application received for the registration and licensing of a medical device shall be recorded.

(b)

The particulars to be entered in such register shall be as prescribed.

(4)

The Authority shall upon receipt of an application submit a copy of that application together with the sample of the medical device and all particulars, available –

(a)

to the MDEC, for the evaluation of the application and the medical device considering the need to ensure the availability of efficacious, safe and good quality medical device relevant to the healthcare needs of the public at an affordable price; and

(b)

to the NMQAL, for testing of the quality of the medical device.

(5)

The Authority shall inform the applicant in writing of the receipt of the application.

(6)

The Minister may make regulations –

(a)

setting out the procedures to be followed, by the

MDEC and the NMQAL in their respective testing or evaluation processes;

(b)

specifying—

(i)

the time-limits in conducting such testing or evaluation;

(ii)

the manner in which the MDEC to conduct its meetings and the procedure to be followed at such meetings; and

(iii)

the matters which should be included in the reports to be submitted.

(7)

(a)

The Authority may require the MDEC and the

NMQAL to finalize the evaluation or testing within a specified time period considering the urgency of the medical device.

(b)

The MDEC and the NMQAL shall within the time limits specified submit their reports to the Authority unless there are compelling reasons for any delay.

Read on from s 84

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