Page 26 - AMMI Annual Report 2016

MEETINGS AND FEEDBACK

13 September & 19 October : MDA Mee ng with Industry – Dra Guidance on Code of
Adver sement for Medical Device, Putrajaya
The first mee ng was a ended by Ms Chuah Chiew Teng (3M), Ms Chloe Tan (Medtronic) and
Ms Grace Wong (Johnson & Johnson). The subsequent mee ng was a ended by Ms Chloe Tan.
The following issues are pending commi ee decision
Ÿ 3.3.2 Endorsement by Health Professionals - Sugges on to exclude this clause for adver sement
to Healthcare Professionals (HCP)
Ÿ 3.3.7 Superla ves – Sugges on to exclude this clause for HCP
Ÿ 3.4.1 Claims rela ng to ageing and premature ageing and Annex B – Sugges on to exclude word
an -ageing
Ÿ 3.10.2, 3.10.3 and 3.10.5 – Sugges on to exclude these clauses for adver sement to HCP.

30 September: AMMI Nomina ons for the MDA Medical Research and Ethics Commi ee
2016-2018
AMMI nominated Dato’ Dr’ Haminnuddin (Ideal Healthcare Sdn. Bhd.) as Representa ve and
Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.) as Alternate Representa ve.

13 October : MDA Mee ng with Industry : Dra Guidance: “Guideline For Registra on Of
Drug-Medical Device And Medical Device-Drug Combina on Products”, Putrajaya
Dato’ Dr Haminnuddin and Ms Grace Wong (Johnson & Johnson Sdn.Bhd.) represented AMMI in the
mee ng. Issues highlighted by the industry were transi on period / effec ve date, parallel submission
to NPRA and MDA, GDPMD/ GMP/ISO requirement, validity period for endorsement le er, process
meline review in the event the drug and device obtained approval separately, endorsement le er
by NPRA/MDA and change/ varia on issues. All are s ll pending final decision from MDA.

26 October : MDA Seminar with Medical Device Industry, Penang
Ms Gan Poh Siew (Haemone cs Malaysia Sdn. Bhd. ) and Ms Queenie Lee (KLS Mar n Sdn. Bhd.)
a ended the seminar on behalf of AMMI. Topics presented during the seminar were :
Ÿ New Policies and Guidelines to Support the Implementa on of Medical Device Act
Ÿ Registra on by way of Verifica on Process
Ÿ Medical Device Exemp on Order 2016
Ÿ Establishment Licensing
Ÿ Cer ficate of Free Sale, Export Permit, Off-take Agreement and Future Programmes for Industrial
Support
Ÿ New Requirements for Regula ng Labelling
Ÿ Post Market Surveillance & Vigilance

1 December : Industry Standards Commi ee – Medical Device (ISC R) Mee ng, SIRIM, Shah Alam
Ms Chuah Chiew Teng (3M Malaysia Sdn.Bhd.) represented AMMI in the mee ng. She reported that the
2nd Medical Device Regula on will consist of (1) Adver sement (2) Maintenance (3) Post Market
Surveillance and (4) Designated Medical Device (eg: devices used in beauty salon – laser etc.) users will also
be regulated.

24 AMMI Annual Report 2016