Licensing Authority in Barbados - Find local businesses in Barbados at.Barbados Licensing Authority, Bridgetown, Barbados.After furnishing all additional request to the authority, the full registration certificate with a longer expiration date will be granted. NMRA will mention if they require any additional information/documentation. This certificate will be valid for 1 or 2 years. LICENSE TRANSFER: Transferring registration certificate from one MAH to another MAH is possible and application to NMRA is required.ĪUTHORIZED REPRESENTATIVE: All foreign medical device manufactures must appoint a Marketing Authorization Holder in Sri Lanka who shall be responsible for the registration, licensing, importation, sale and distribution, handing of quality failures and all aspects pertaining to the particular medical device in Sri Lanka.ĪDDITIONAL INFORMATION: Each new product will always be granted a 1-year provisional registration certificate. Provisional registration certificate – 1 or 2 years LOCAL FEES (Manufacturer): Additional fee will be required for foreign manufacturer on-site audit. Its member states are Afghanistan, Bangladesh, Bhutan, India, the Maldives, Nepal, Pakistan and Sri Lanka. *SAARC countries is the regional intergovernmental organization and geopolitical union of states in South Asia. On-site Inspection: USD 15000 (SAARC Countries*) USD 20000 (other countries) Feeding bottles, toothbrush, and medical gas cylinders.Īpproval from Atomic Energy Authority of Sri Lanka is required for radiation emitting devices.Ĭertificate registration issuance: USD 400.
Plasters, gauze, sanitary napkins, bandages, latex condoms, surgical and examination gloves etc.Devices which are in contact directly with the blood stream.Local testing is required for the following type of devices: The approval of foreign manufacturing facility, however, is required as the pre-requirements to apply for such import license. Therefore, import license will be required to import the sample. Two (2) product samples will be required as part of the registration. An on-site audit may be necessary, but NMRA would exempt on-site audit if the site had been inspected by a stringent regulatory authority or WHO. SPECIAL REQUIREMENT: Foreign manufacturing facility must be registered to and approved by NMRA. TIMEFRAME: New full product registration will take a minimum of 6 months. Medical Devices: Listed Device/I/IIa/IIb/III REGULATORY AUTHORITY: National Medicines Regulatory Authority (NMRA)
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