Affiliate Members

Regulatory Authorities who would like to engage with IMDRF, but do not wish to become or are not Official Observers, may apply to become Affiliate Members. As an Affiliate Member, the regulatory authority will participate in IMDRF by attending “open” meetings and using IMDRF documents in part or in whole as the basis for their own regulatory framework. Affiliate Members may also participate in open Working Groups.

Affiliate Member Representatives

Chile - Public Health Institute (ISP)

• Maria Cecilia López
  Head of the Medical Device Registration Office
  Email: sarit.sivan [at] moh.gov.il (m)mclopez [at] ispch.cl (clopez[at]ispch[dot]cl)
• Catalina Valdés
  Head of Medical Technovigilance Office
  Email: cvaldes [at] ispch.cl (cvaldes[at]ispch[dot]cl)

Chinese Taipei - Taiwan Food and Drug Administration (TFDA)

• Ms Cheng-Ning Wu
  Senior Technical Specialist
  Division of Medical Devices and Cosmetics
  Email: dimakatso.mathibe [at] sahpra.org.za (e)emilywu [at] fda.gov.tw (milywu[at]fda[dot]gov[dot]tw)
• Mr Hsiu-Te Lin
  Section Chief
  Division of Medical Devices and Cosmetics
  Email: portia.nkambule [at] sahpra.org.za (s)shoulder0705 [at] fda.gov.tw (houlder0705[at]fda[dot]gov[dot]tw)

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED) 

• Dr Mario Cesar Muñiz Ferrer
  Head of Medical Devices Department
  Email: mario [at] cecmed.cu (mario[at]cecmed[dot]cu)
• MSc Yadira Alvarez Rodriguez
  Specialist of Medical Devices Department
  Email: yadira [at] cecmed.cu (yadira[at]cecmed[dot]cu)

Egypt - Egyptian Drug Authority (EDA)

• Dr Miriam Boles
  Head of the Central Administration of Medical Devices (CAMD)
  Email: mario [at] cecmed.cu (m)miriam.boles [at] edaegypt.gov.eg (iriam[dot]boles[at]edaegypt[dot]gov[dot]eg)
• Dr Sondos Moshtohry
  Office of the Chairman
  Email: yadira [at] cecmed.cu (s)ondos.moshtohry [at] edaegypt.gov.eg

El Salvador - National Directorate of Medicines (DNM)

• Mr. Mario Ernesto Vega Valenzuela
  Head of the Medical Devices Unit
  Email: mario.vega [at] medicamentos.gob.sv (mario[dot]vega[at]medicamentos[dot]gob[dot]sv) 
• Mrs. Karina Lucia Flores de Barriere
  Supervisor of Analysis and Quality Control for Medical Devices Laboratory
  Email: karina.flores [at] medicamentos.gob.sv (karina[dot]flores[at]medicamentos[dot]gob[dot]sv)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

Israel - Medical Technologies, Health Information, Innovation and Research (MTIIR)

• Dr Sarit Sivan
  Head of the Medical Device Division
  Email: sarit.sivan [at] moh.gov.il (sarit[dot]sivan[at]moh[dot]gov[dot]il)
• Dr Anat Boehm-Cagan
  Head of Medical Technologies Regulation and Regulatory Partnerships
  Email: anat.boehm-cagan [at] moh.gov.il (anat[dot]boehm-cagan[at]moh[dot]gov[dot]il)

Jordan - Jordan Food and Drug Administration, (JFDA)

• Dr Shatha Al-Quraan
  Head of the Medical Services Registration Department
  Email: shatha.al-quraan [at] jfda.jo (shatha[dot]al-quraan[at]jfda[dot]jo)
• Dr Nagham Al Horani
  Director Medical Devices Directorate
  Email: nagham.al-horani [at] jfda.jo (nagham[dot]al-horani[at]jfda[dot]jo)

Kenya - Pharmacy and Poisons Board (PPB)

• Paulyne Wairimu
  Head of the Medical Devices and Diagnostics, Health Technologies
  Email: pwairimu [at] ppb.go.ke (pwairimu[at]ppb[dot]go[dot]ke)
• Kariuki Gachoki
  Deputy Director, Product Evaluation and Registration, Medical Products
  Email: wgachoki [at] ppb.go.ke (wgachoki[at]ppb[dot]go[dot]ke)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

• Edgardo Arenas Gasca
  Liaison of International Affairs
  Email: earenas [at] cofepris.gob.mx (earenas[at]cofepris[dot]gob[dot]mx)

Montenegro - Institute for Medicines and Medical Devices (CinMED) 

• Mira Kontić LL.M.
  Deputy Managing Director
  Email: Mira.Kontic [at] cinmed.me (Mira[dot]Kontic[at]cinmed[dot]me)
• Maja Petrović, PharmD
  Medical Devices Expert
  Email: Maja.Petrovic [at] cinmed.me (Maja[dot]Petrovic[at]cinmed[dot]me)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

• Mr. Emmanuel Emori Armon
  Deputy Director
  National Agency for Food and Drug Administration Control
  Email: armon.emmanuel [at] nafdac.gov.ng (armon[dot]emmanuel[at]nafdac[dot]gov[dot]ng)
• Mrs. Adegoke Iyabowale 
  Deputy Director
  National Agency for Food and Drug Administration Control
  Email: iyabowale.adegoke [at] nafdac.gov.ng (iyabowale[dot]adegoke[at]nafdac[dot]gov[dot]ng)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

• Dr Dimakatso Mathibe
  Senior Manager, Medical Devices and Radiation Control
  Email: dimakatso.mathibe [at] sahpra.org.za (dimakatso[dot]mathibe[at]sahpra[dot]org[dot]za)
• Ms Portia Nkambule
  Chief Regulatory Officer
  Email: portia.nkambule [at] sahpra.org.za (portia[dot]nkambule[at]sahpra[dot]org[dot]za)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

• Ms. Kissa Watson Mwamwita
  Director, Medical Devices and Diagnostics Control
  Email: kissa.mwamwitwa [at] tmda.go.tz (kissa[dot]mwamwitwa[at]tmda[dot]go[dot]tz)
• Ms. Rehema Forgen Mariki
  Manager, Medical Devices and Diagnostics Assessment
  Email: rehema.mariki [at] tmda.go.tz (rehema[dot]mariki[at]tmda[dot]go[dot]tz)