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pdf 4a. User Manual MDR A Front End User.pdf ( pdf, 7.18 MB ) (1251 muat turun) Popular
pdf 4b. User Manual MDR BCD Front End User.pdf ( pdf, 5.85 MB ) (4193 muat turun) Popular
pdf 5 JKTPP Schedule Planner 2022 ( pdf, 105 KB ) (2458 muat turun) Popular
pdf 5a. GMD Risk Classification.pdf ( pdf, 253 KB ) (9233 muat turun) Popular
dokumen 5APPEN_1.DOC ( doc, 233 KB ) (1254 muat turun) Popular
pdf 5b. IVD Risk Classification.pdf ( pdf, 177 KB ) (3003 muat turun) Popular
pdf 6 Clinical Investigational Plan (CIP) ( pdf, 195 KB ) (3027 muat turun) Popular
pdf 6a. Grouping GMD.pdf ( pdf, 236 KB ) (4282 muat turun) Popular
pdf 6b. Grouping - IVD.pdf ( pdf, 177 KB ) (2717 muat turun) Popular
pdf 7 Clinical Performance Study Protocol (CPSP) ( pdf, 123 KB ) (4341 muat turun) Popular
pdf 7 Investigator's Brochure (IB) ( pdf, 109 KB ) (2360 muat turun) Popular
pdf 7. Conformity Assessment for Medical Device.pdf ( pdf, 275 KB ) (3185 muat turun) Popular
pdf 7. Conformity Assessment for Medical Device.pdf ( pdf, 274 KB ) (2832 muat turun) Popular
pdf 7. Process Flow for Approval Letter for Changes to Ancillary Medical Device Component Application.pdf ( pdf, 36 KB ) (1023 muat turun) Popular
pdf 8 Investigator's Brochure (IB) ( pdf, 174 KB ) (6037 muat turun) Popular
pdf 8. Recognized foreign regulatory authorities and notified bodies and the respective approval types eligible for conformity assessment by way of verification process.pdf ( pdf, 98 KB ) (5576 muat turun) Popular
pdf 9.Fee Structure MDR.pdf ( pdf, 253 KB ) (11413 muat turun) Popular
pdf AKAUNTAN GRED WA41.pdf ( pdf, 698 KB ) (1269 muat turun) Popular
pdf AKAUNTAN GRED WA41.pdf ( pdf, 695 KB ) (2414 muat turun) Popular
pdf ANNEX A.pdf ( pdf, 28 KB ) (6802 muat turun) Popular

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