A Closer Look at the Requirements on Original Equipment Manufacturing (OEM) and 'Makloon' Products Based on the New Minister of Health Regulation on Marketing Authorization for Medical Devices, In Vitro Diagnostic Medical Devices and Household Medical Supplies
As we have discussed in our previous client alert, click here, the Minister of Health (MOH) issued Regulation No. 62 of 2017 on Marketing Authorization for Medical Devices, In Vitro Diagnostic Medical Devices and Household Medical Supplies (Regulation 62) on 29 December 2017.
Regulation 62 revokes MOH Regulation No. 1190/MENKES/PER/VIII/2010 on Marketing Authorization for Medical Devices and Household Medical Supplies (Peralatan Kesehatan Rumah Tangga or PKRT) (Regulation 1190).
Among others, Regulation 62 introduces two new terms:
- Original Equipment Manufacturer (OEM)
- Contract Manufacturing (Makloon1)
The concepts of OEM and Makloon are commonly known in practice. The MOH itself has acknowledged these concepts and allow such practice where a manufacturer can sub-contract the manufacturing of its medical devices to another party (albeit on a policy basis).
Before the issuance of Regulation 62, the MOH has never put in writing its view regarding OEM and Makloon activities for medical devices (read: based on a regulation).
Business actors need to pay more attention to the OEM and Makloon provisions stipulated under Regulation 62, as they might not have an "apple-to-apple" comparison with the views and policies that the MOH adopted before the issuance of Regulation 62.
Regulation 62 will prevail over the previous unwritten views or policies adopted by the MOH (i.e., on OEM and Makloon activities) in case there is discrepancy between them.
If business actors continue to carry out or engage in OEM and Makloon activities based on their pre-conceived understanding of OEM and Makloon (i.e., before the issuance of Regulation 62), then there is a risk that business actors might find themselves violating the provisions of Regulation 62.
Non-Toll Manufacturing (OEM) and Toll Manufacturing (Makloon) under Regulation 62
Below are the descriptions of OEM and Makloon based on Regulation 62:
- Based on Article 1.13 of Regulation 62, "Makloon" means delegation of part or the whole of the manufacturing process of medical devices, in vitro diagnostic medical devices ("IVDs") or PKRTs from a Local Manufacturer2 that is also a Product Owner3 that holds a production certificate to another Local Manufacturer that holds a production certificate.
- Based on Article 1.14 of Regulation 62, "OEM" is a production activity that is done by a Local Manufacturer/Foreign Manufacturer4 based on the request of a PAK or PKRT company as the Product Owner using the trademark from the Product Owner.
In general practice, Makloon is basically a toll manufacturing activity, while OEM is basically a non-toll manufacturing activity.
Notable Requirements and Features (Comparison)
|OEM (Non-Toll Manufacturing)||Makloon (Toll Manufacturing)|
|Ownership of the Product||
|Contractor||The medical device wholesaler (Penyalur Alat Kesehatan or PAK) and PKRT company who own the product (i.e., Product Owners) are the contractors in an OEM arrangement.||The Local Manufacturer who owns the product (i.e., Product Owner) and sub-contracts part of its manufacturing activity is the contractor in a Makloon arrangement.|
|Prohibition to Register Similar Products||
|Effective Period and Extension of Product Registration||
Regulation 62 provides quite descriptive provisions that describe how the MOH will treat OEM and Makloon products in practice. Business actors should be wary not to miss any provision under Regulation 62 that are not reviously covered in MOH's unwritten policy.
It remains to be seen whether the MOH will further regulate OEM and Makloon in a more specific implementing regulation. In the absence of such regulation, the MOH may develop new views on OEM and Makloon.