Page 27 - AMMI Annual Report 2016

AMMI’S COLLECTIVE FEEDBACK

Subject : Transi onal Period for Implementa on of Medical Device Labelling
Submi ed : 30 May 2016

PROPOSED TRANSITIONAL PERIOD : 3 years
AMMI proposes a stepwise approach in enforcing the labelling requirement over a period of three (3)
years – which will be more feasible when the industry has se led down with the current registra on
exercise.

JUSTIFICATION ON PROPOSED TRANSITIONAL PERIOD

1. EQUIPMENT
Ÿ Purchase of new label prin ng equipment requires me and capital investments (sourcing,
equipment qualifica ons, so ware valida on, training).
Ÿ Re-configura on of exis ng prin ng equipment to cater for the new labelling requirements
(equipment qualifica ons, so ware valida on, training).

2. LABELLING
Ÿ Label design, review and approval of artworks and language transla on (Internal and External
Par es) requires me and resources.
Ÿ Purchase of new labels requires me and resources (artwork design/redesign, verifica on, order
lead me, inspec on etc.).
Ÿ Industry will require MDA to allow “s ckering” of labels.

3. PHASING OUT OF CURRENT STOCKS
Ÿ Clearance of exis ng label stocks – me required especially for slow moving products
Ÿ Clearance of physical stocks with exis ng labels from manufacturing plants, warehouses,
distribu on centers and distributors.
Ÿ Phased transi on from exis ng to new labels for marketed products.
Ÿ Cost factor - Inventory/stock of old artwork to be used before replenishing the new. Also, some
devices are slow-moving.

4. UPDATE OF PRODUCT REGISTRATION
Ÿ The “Registered with MDA” label can only be affixed a er obtaining registra on approval from
MDA. Registra on is by “family”, hence revision of numerous artwork will be required at any one
me. Addi onal transi on period is required upon approval, in order to revise the artwork and
labels of products.
Ÿ The industry needs MDA’s confirma on that the labelling of “Registered with MDA” is
mandatory for devices placed in the Malaysian market only (and not required for export).
Ÿ A transi on period is required before the company obtains the cer ficate from MDA. This is
important for those products which its registra on applica on has been submi ed to MDA
th
before 30 June 2016 and have the benefit of con nuous commercial ac vity in local market.
Ÿ Time and resources needed at MDA to review and approve new labels in the product
registra on dossier. In addi on, for the export market (for products with shared labels with
other countries), ample transi on me is required to revise artwork and receive approval
from other markets before new labels can be implemented.

AMMI Annual Report 2016 25