General considerations for medical device preliminary analysis:
· Status of GHTF (EU, US, Canada, Japan, Australia) country approval, country of origin approval, and/or ISO 13485 certificate
· Product classification under current approvals
· Intended purpose and IFU (Instructions for Use) documentation
· Available product technical files such as: risk management file, clinical evaluation report, IEC 60601 series test report
· Customer local representative arrangements
· Factory location
· Wireless function/technology if applicable, and specifications
We can assist you for market access in the countries below – with a focus on:
· Preliminary analysis/Classification identification
· Product testing arrangements/Certification process advice
· Required documentations/Coordination for site audit
Brazil – INMETRO Certification
· Assistance for mandatory INMETRO (National Institute of Metrology, Quality and Technology) (Ordinance 54) certification based on IEC 60601 series
· Reports need to be issued by ILAC or IAAC labs – less than 2 years, or 4 years for large-scale equipment
· Factory inspection and applicant audit is required
· 5 years validity; Certification Maintenance every 15 months
S. Korea – MFDS
· Assistance for application of type test. If CB report and certificate are available, upon review, the type test can be skipped
· Assistance for technical document review (Class Ⅱ to Korean CB, Class Ⅲ ~ Class Ⅵ to MFDS)
· Assistance and coordination of GMP Audit (QMS Inspection)
· Application of MFDS product approval (to MFDS)
Russia – Registration and Gost-R Certification
· Class I, IIa, IIb, III
· ROSZDRAVNADZOR (RNZ, Ministry of Health) registration, Gost-R declaration
· Local technical testing (safety, EMC, performance, biocompatibility) only after obtaining permission from RNZ
· Clinical data assessment (clinical investigation or documentation review normally for Class I) can only be issued by RNZ-accredited hospital in Russia
Saudi Arabia – SFDA Marketing Authorization
· Class I, IIa, IIb, III
· Based on prior approval in GHTF founding countries (EU, US, Canada, Japan, Australia), such as CE, FDA, etc.
· Applicant must be an authorized representative licensed by SFDA, except for Class I non-sterile products
· Distributors/importers need to list the product after Marketing Authorization
· Must consider Saudi deviation: 127 or 220 or 380 V, 60Hz
· Validity up to 3 years, depending on the remainder of GHTF country approval