To obtaining the Sanitary Certification for legal commercialization of any medical device in Panama, is due to fulfill the established in the: “Decreto Ejecutivo 178 de 12 de julio de 2001 que reglamenta la Ley 1 de 10 de enero de 2001, sobre Medicamentos y otros Productos para la salud humana en la República de Panamá” To obtain the Sanitary Certification in Panama the following documents are requested; 1. Formal letter from the supplier granting PANLAB Supply Corp. as distributor and authorizing PANLAB Supply Corp. to import, sell and obtain regulatory clearance of the product to commercialize. >>This letter should be notarized as prove of authenticity in the country of origin.<< 2. Copy of manufacturer certificate of Good Manufacturing Practices (ISO, CE, TUV, FDA, etc) or Certificate of Free Sale to foreign governments issued by the Health Authority of the country of origin. >>This copy should be notarized as prove of authenticity in the country of origin.<< 3. Other information may be required according to the category of supply. Disclosure: This information was obtained from the Sanitary Certification Department at the Panamanian Public Health Central Laboratory “Instituto Conmemorativo Gorgas de Estudios de la Salud”. PANLAB Supply Corp. Bella Vista Calle 33; Edificio Central 33, 1er Piso Oficina # 2; Ciudad de Panamá, Panamá Tel.: (507) 391-6266 www.panlabsupplycorp.com [… Supplier name Here …] [… Supplier address Here …] [… Supplier Logo Here …] Date To Whom It May Concern We; [… Supplier name and Supplier address goes here …] hereby declare to all those concerned that PANLAB Supply Corp., located at the address below: PANLAB Supply Corp. Calle 33, Bella Vista Edificio Central 33, Primer Piso- Local 2 Ciudad de Panamá, Republica de Panamá is an authorized distributor of [… Supplier name goes here …] inside the territory of the Republic of Panama. The company, PANLAB Supply Corp. is duly authorized to promote, sell, and obtain regulatory clearance for our products as well as to send quotations and participate in bids in the Republic of Panama. This appointment is effective until further notice. Sincerely, [… Supplier authority name and signature …] [… Notary stamp and signature here …]
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