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.

*An example of a completed Affiliate Application Form can be found here

Affiliate Member Representatives

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

• Mr Batlegang Dallas Mosweu
  Head of Medical Devices Unit
  Email: bmosweu [at] bomra.co.bw (bmosweu[at]bomra[dot]co[dot]bw)
• Ms Kesego Moalosi
  Regulatory Officer Medical Devices
  Email: kmoalosi [at] bomra.co.bw (kmoalosi[at]bomra[dot]co[dot]bw)

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)

• Mr Ching-Wei Chang
  Section Chief
  Division of Medical Devices and Cosmetics
  Email: pacmf2356 [at] fda.gov.tw (pacmf2356[at]fda[dot]gov[dot]tw)
• Dr Shang-Ching Lin
  Associate Researcher
  Division of Medical Devices and Cosmetics
  Email: sclin [at] fda.gov.tw (sclin[at]fda[dot]gov[dot]tw)

Costa Rica- Ministry of Health

• Dr. Juan de Dios Jaime Rumoroso Solis
  Medical Specialist for the CNFV-CNTV
  Email: jaime.rumoroso [at] misalud.go.cr (jaime[dot]rumoroso[at]misalud[dot]go[dot]cr)
• Dra. Ileana Roverssi Picado
  Medical Specialist for the CNFV-CNTV
  Email: ileana.roverssi [at] misalud.go.cr (ileana[dot]roverssi[at]misalud[dot]go[dot]cr)

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)

Dominican Republic- General Directorate of Medicines, Food and Health Products (DIGEMAPS)

• Leandro Villanueva
  General Director of DIGEMAPS
  Email: lvillanueva [at] digemaps.gob.do (lvillanueva[at]digemaps[dot]gob[dot]do)
• Darwin Marcelo
  Chief of Staff
  Email: dmarcelo [at] digemaps.gob.do (dmarcelo[at]digemaps[dot]gob[dot]do)

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 - Sanitary Regulation Superintendency (SRS)

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

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

• Dr Sharmarke Sharif Bulle
  Deputy Director General of the Medical Device Sector
  Email: dci [at] nic.in (dci[at]nic[dot]in)
• Mikiyos Petros
  Medical Device Manufacturer Inspection & Law Enforcement Lead Executive Officer
  Email: mpetros [at] efda.gov.et (mpetros[at]efda[dot]gov[dot]et)

India - Central Drugs Standard Control Organisation (CDSCO)

• Dr Rajeev Singh Raghuvanshi
  Drugs Controller General of India
  Email: dci [at] nic.in (dci[at]nic[dot]in)
• Mr Aseem Sahu
  Deputy Drugs Controller (India)
  Head of Medical Devices Division
  Email: aseem.sahu [at] cdsco.nic.in (aseem[dot]sahu[at]cdsco[dot]nic[dot]in)

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)
• Ms Tal Naggan
  Head of Medical Technologies National Projects and International Regulatory Partnerships
  Email: tal.naggan [at] MOH.GOV.IL (tal[dot]naggan[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)

Malaysia - Medical Device Authority (MDA)

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
  Email: armon.emmanuel [at] nafdac.gov.ng (armon[dot]emmanuel[at]nafdac[dot]gov[dot]ng)
• Mrs. Adegoke Iyabowale 
  Deputy Director
  Email: iyabowale.adegoke [at] nafdac.gov.ng (iyabowale[dot]adegoke[at]nafdac[dot]gov[dot]ng)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

• MSc. QF Jorge Iliou Silvero
  National Director
  Email: jorge.iliou [at] dinavisa.gov.py (jorge[dot]iliou[at]dinavisa[dot]gov[dot]py); secretariageneral [at] dinavisa.gov.py (secretariageneral[at]dinavisa[dot]gov[dot]py)
• Q.F. Alison Iglesias
  Director of the Directorate of Medical and Dental Devices
  Email: alison.iglesias [at] dinavisa.gov.py (alison[dot]iglesias[at]dinavisa[dot]gov[dot]py); relaciones.internacionales [at] dinavisa.gov.py (relaciones[dot]internacionales[at]dinavisa[dot]gov[dot]py)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

• Delia Florencia Dávila Vigil
  General Director of DIGEMID
  Email:ddavila [at] minsa.gob.pe ( ddavila[at]minsa[dot]gob[dot]pe)
• Mr. Jose Carlos Saravia Paz Soldán 
  Executive Director Medical Devices and Sanitary Products 
  Email: jsaravia [at] minsa.gob.pe (jsaravia[at]minsa[dot]gob[dot]pe)

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)

Tanzania - Zanzibar Food and Drug Agency (ZFDA) 

• Salma Hafidh Ali
  Head of Medical Device Control Division
  Email: salma.ali [at] zfda.go.tz (salma[dot]ali[at]zfda[dot]go[dot]tz)
• Harith Assaa Ahmad
  Medical Device Officer
  Email: harith.ahmad [at] zfda.go.tz (harith[dot]ahmad[at]zfda[dot]go[dot]tz)

Uzbekistan - The Center for Pharmaceutical Products Safety

• Mr. Alisher Temirov
  Director, Center for Pharmaceutical Products Safety
  Email: pharmrelations [at] ssv.uz (pharmrelations[at]ssv[dot]uz)
• Mr Dishod Payziev
  Chairman of Committee on New Medical Devices
  Center for Pharmaceutical Products Safety
  Email: d.payziyev [at] pharmcenter.uz (d[dot]payziyev[at]pharmcenter[dot]uz)

Zimbabwe - Medicines Control Authority (MCAZ)

• Richard T Rukwata
  Director General
  Email: rrukwata [at] mcaz.co.zw (rrukwata[at]mcaz[dot]co[dot]zw)
• Linda Nhukarume
  Senior Analyst Microbiology and Medical Devices
  Email: nhukarumel [at] mcaz.co.zw (nhukarumel[at]mcaz[dot]co[dot]zw)