Drug Regulatory Authority (DRA) hereby notifies all potential importers (Market Authorization Holders) that Import Authorization from DRA is required for importation of any medical syringes.
Following documents shall be furnished at the time of Import Application:
i. Manufacturer and packaging details (in the absence of products samples);
ii. Description of the intended use(s) of the syringe. If the syringe is labelled for use with a specific drug or biologic, the applicant must supply information demonstrating that use of the drug/biologic with the device is consistent with the
approved drug/biologic labelling;
iii. Specifications for the syringe (physical, mechanical, chemical specifications);
iv. Certificate of Analysis (of any three batches or the corresponding batch to be imported);
v. ISO 13485 certifications or evidence of home market approval (e.g., CE Certificate, 510 (K) Clearance, etc) or any other NRA approval;
vi. Instruction for use; and
vii. Proforma invoice and price structure
This regulatory notification is issued for immediate compliance and has reference to the
approved note DRA/D1/31-Med-Device/20-21/933 dated 20 May 2021 by the Hon’ble
Chairperson, Bhutan Medicines Board.
For further information and clarification, kindly contact the Registration Division, Drug Regulatory Authority at +975-2-337074/337075.
November 23rd, 2021
November 4th, 2021
October 8th, 2021
September 9th, 2021
July 12th, 2021
June 28th, 2021