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Contents

Part IV · General

69. Constitution of the MDEC

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

(1)

The MDEC shall consist of the following persons who shall be appointed by the Authority-

(a)

ex-officio members-

(i)

the head of the MDR Division who shall function as the Chairman of the Committee;

(ii)

the Deputy Director General of Laboratory

Services of the Ministry;

(iii)

the Deputy Director - General of Dental

Services of the Ministry;

(iv)

the Deputy Director - General (Biomedical

Engineering) of the Ministry;

(v)

the Head of the National Medicines Quality

Assurance Laboratory (NMQAL);

(b)

nominated members-

(i)

a Professor or a Senior Lecturer in

Pharmacology of any University established under the Universities Act, No. 16 of 1978, nominated by the Deans of Medical Faculties of such Universities;

(ii)

a Professor or Senior Lecturer in Pharmacy of any University in Sri Lanka established under the Universities Act, No.16 of 1978, nominated by the Deans of relevant Faculties;

(iii)

a Professor or a Senior Lecturer in

Biomedical Engineering from any University in Sri Lanka established under the Universities

Act, No. 16 of 1978, nominated by the

University Grants Commission;

(iv)

the Director of the Sri Lanka Standards

Institute established under the Sri Lanka

Standards Institute Act, No.6 of 1984, or his nominee;

(v)

the Director – General of the Sri Lanka

Atomic Energy Board and the Director-General of the Sri Lanka Atomic Energy

Regulatory Council appointed under the Sri

Lanka Atomic Energy Act, No. 40 of 2014, or their nominees;

(vi)

a Consultant in Transfusion Medicine, nominated by the Sri Lanka College of

Transfusion Physicians;

(vii)

a Consultant General Surgeon, nominated by the College of Surgeons of Sri Lanka;

(viii)

a Consultant Microbiologist nominated by the Sri Lanka College of Microbiologists;

(ix)

a Consultant Biochemist, nominated by the

Association of Biochemists;

(x)

a Consultant Anesthesiologist, nominated by the Sri Lanka College of Anesthesiologists;

(xi)

an Oral Maxillo Facial Surgeon, nominated by the College of Dental Surgeons of Sri

Lanka;

(xii)

a Consultant Physician nominated by the

Ceylon College of Physicians;

(xiii)

a Consultant Radiologist nominated by the

Sri Lanka College of Radiology; and

(xiv)

a Pharmacist in charge of the subject of medical devices in the Authority nominated by the Authority.

(2)

The quorum for meetings shall be seven members excluding the members of the Panel of Experts.

(3)

The term of office of a nominated member shall be three years.

Part V

General

Part VI

Rules and Regulations

Part VII

Repeals and Transitional Provisions

Part VIII

Interpretation