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Please take note that there are some situations where an organisation needs to comply with ISO 13485 requirements instead of GDPMDS TS-01 Rev 2.

Below is the difference between secondary assembly activities and manufacturing activities with which the organization may be involved in performing in one of these activities.

a) Only change in quantity (eg: 10 pcs to 20 pcs)

Secondary AssemblyISO 13485:2003
Any changes to the following, this standards applies:
  • No change on the labelling information eg no change in the expiry date.
  • Change on the labelling information (eg: change in the expiry date).
  • No change in the brand name.
  • Change in the brand name.
  • No change in product owner.
  • Change in product owner.
  • No assignment of new primary label.
  • Assignment of new primary label.
  • No sterilization information to the medical device.
  • Sterilization information to the medical device.
No change/impact to the original primary labelling/packaging.

 

Any change to the original primary labelling/packaging has an impact.


 b) Change from component to devices (eg: components A,B,C to device Y).

Secondary AssemblyISO 13485:2003
Any changes to the following, this standards applies:
  • No change on the labelling information eg no change in the expiry date.
  • Change on the labelling information (eg: change in the expiry date).
  • No change in the brand name.
  • Change in the brand name.
  • No change in product owner.
  • Change in product owner.
  • No assignment of new primary label.
  • Assignment of new primary label.
  • No sterilization information to the medical device.
  • Sterilization information to the medical device.

No change/impact to the original primary labelling/packaging.

 

Any change to the original primary labelling/packaging has an impact.

Secondary label shall only consists: 
List of items.

Expiry date for secondary packaging, based on component with the shortest expiry date.

Package label “Packed for <customer name>”.

Product identifier code for secondary package.

Not applicable to this standard.

Third party logistics (3PL)

Does not considered Secondary assembly and also not manufacturing activities (ISO 13485:2003) for shipping and transportation.

a) Only change in quantity for shipper carton (eg: 10 to 40 boxes).


Secondary Assembly

ISO 13485:2003

No change on the labeling (as per original primary label) information eg no change in the expiry date.

No change in the brand name.

No change in product owner.

Not applicable to this standard.

No assignment of new primary label

No sterilization information to the medical device.

For further clarification, please email Ms. Lee Lai Mei or Mr. Kenny Ang.

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.

SGS has a network of qualified auditors able to provide certification for the quality system standard ISO 13485:2003, Good Distribution Practice for Medical Devices in Singapore (GDPMDS), directive 93/42/EEC and directive 98/79/EC. SGS training services provide training courses on ISO 13485, IVD Directive and Medical Devices Directive, delivering first class training based on our professional competency as a Notified Body and Certification Body.

To learn more, visit Medical Devices.

Lee Lai Mei
Business Manager
SGS International Certification Services Singapore Pte Ltd
26 Ayer Rajah Crescent #03-07
Singapore 139944

t: +65 6379 0111
f: +65 6778 7780

ABOUT SGS

The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.