1. BHS Company Introduction BHS Consultant Eva Sohn 2014.Dec homepage: bhservice.kr

2. What does BHS do ? MFDS registration : Medical Device Medicine Functional cosmetics ◦ Communicate with foreign manufacture directly. GMP inspection consulting (Foreign/Local manufacture) ◦ GMP inspection by MFDS is essential. Medical Insurance Fee consulting (under HIRA) To enter Korean Market, [Medical Device / Medicine / Functional cosmetics], company must get product approval & register Product at [Ministry of Food and Drug Safety: MFDS]. And Company must follow MFDS’s request continuously. There is the difference between Korean registration process & foreign country. So expert’s management is needed for your successful Korean Market launch.

3. CEO Profile CEO & consultant has much work experience at medical field. To communicate with MFDS officer, practical experience & knowledge is essential. BHS will search & provide a customized solution. 1998 Analytical Chemical Master 1998 JAN. – 2006 JAN. MSD Korea (QC/QA/Material Management) 2006 SEP. – 2007 JUN. Waters Korea (LC Marketing) 2007. AUG. – 2008 JAN. HUONS (QA) 2008. FEB. – SEP. Allergan Korea (QA) 2009. MAY – 2010. FEB. Solomon Medical Research (CRO) 2010. JUN – current MFDS registration consulting

4. Business field Product registration at MFDS : Medical Device Medicine Functional cosmetics Safety Effectiveness Review (include clinical data) GMP / revaluation consulting ◦ Medical Device ◦ Medicine Medical Insurance Fee consulting

5. Strong Point Professional Project management by experienced consultant (QA/QC/RA/CRO experience) : Communicate with Key Person : For effective communication, understanding right direction & information is essential. BHS communicate with key person who know the right direction. BHS provide customized solution to customer. Effective & continuous discussion is the best way. Direct communication with foreign manufacture : There is difference technical document between foreign country & MFDS (Korea). Professional consultant communicate with foreign company to receive technical document checking & receiving. ◦ If MFDS can accept the manufacture’s test report, consultant try to receive a foreign manufacture's test report. (save money & time) Product License & GMP certification Management of MFDS : For Korean sales, GMP inspection performed by MFDS is essential. Professional consult makes progress at once. (Product registration & GMP inspection) ◦ Before Korean sales, product registration & GMP inspection must be completed. Overall Product license management : MFDS request much management & information. Communicate with MFDS and then give a good direction to customer.

6. MFDS Registration Experience 1 – Medical Device Electrosurgical system hand piece, foot-controlled, single-use [class 3] Endotherapy needle, general-purpose, single-use [class 2] Contraceptive, condom, male [class 3] Various Dressing [class 2] Dressing, secondary treatment, high-absorbent, foam/sheet/liquid/powder [class 3] Graft, bone, synthetic [class 4] Bracket, orthodontic [class 2] Dental cement, hybrid ionomer [class 2] Endo-therapy needle, general-purpose, single-use [class 2] Dressing, absorbable, wound, biological origin / Breast prosthesis / Hip prosthesis, internal, total / Orthopaedic fixation plate, biodegradable Technical document review

7. MFDS registration Experience 2 - Medicine. Functional cosmetics High concentration HP teeth whitening gel Kit (undergoing discussion with MFDS) ◦ It is medicine at Korea. At other country, it is medical device Atopic medicine IND approval (for research) Sunscreen Medicine Functional cosmetic

8. GMP consulting Local Medical Device Manufacture ◦ Graft, bone, synthetic [class 4] ◦ Set-up Quality system & documentation ◦ GMP training ◦ Advise process validation Foreign Medical Device manufacture – GMP reevaluation ◦ Contraceptive, condom, male [class 3] ◦ Wound Dressing [class 2] Foreign Medicine Manufacture ◦ High concentration HP teeth whitening gel ◦ Receiving & arrange GMP document ◦ Providing KGMP guideline & indicating check-point ◦ Site GMP inspection companion (as interpreter)

9. Work Process Gathering clear information & direction is the most important Gathering clear information & direction is the most important!! 1 st step : Meeting with client ◦ Product & manufacture Review (classification check) 2 nd step : Receiving technical document – communicate with manufacture staff 3 rd step : Preparation of progress strategy 4 th step : Preparing & submitting supplementation for MFDS registration 5 th step : Preparing & submitting supplementation of MFDS request Depend on work scope, period / cost is changeable