In brief

On 11 May 2024, the Ministry of Health (MOH) issued circular letter No. FR.03.01/E/884/2024 (“Letter“). In the Letter, the MOH announced that a Good Distribution Practice for Medical Devices (Cara Distribusi Alat Kesehatan Yang Baik or CDAKB) certificate will be required as a pre-requisite for the issuance of the product registration (izin edar).

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Contents

1. Previous position
2. Key takeaways 
3. Our takeaways
4. Conclusion

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Previous position

Medical device wholesalers are generally required to implement and comply with CDAKB guidelines set out by the MOH) as part of their business licensing commitment. 

Up to now, the MOH does not require wholesalers to hold a CDAKB certificate before they can apply for and obtain product registrations for medical device products. Based on the Letter, starting from 1 July 2024, a CDAKB certificate will be required. The following prevailing regulations are silent on this matter, and do not expressly specify that a CDAKB certificate is one of the required documents for medical device wholesalers to obtain product registrations: 

1. MOH Regulation No. 62 of 2017 on Product Registration of Medical Devices In Vitro Diagnostic and Household Medical Supplies (“MOH Regulation 62“).
2. MOH Regulation No. 14 of 2021 on Standard of Risk Based Licensing in the Healthcare Sector (“MOH Regulation 14“).

Key takeaways 

Pursuant to the Letter, the MOH will implement its new policy in stages: 

1. MOH will circulate socializations on the implementation of its new policy for CDAKB between 1 May 2024 and 30 June 2024 through its online platform (i.e., ‘regalkes‘). 
2. MOH will implement the new policy and require wholesalers to obtain CDAKB certificate as pre-requisite for obtaining product registration starting 1 July 2024. 

(Any information regarding CDAKB certificate application may be accessed through the following link: sertifikasialkes.kemkes.go.id)).

Our takeaways

• It remains to be seen how the MOH will implement the Letter in the future (after 1 July 2024) against issued product registrations of non-CDAKB certificated medical device wholesalers. 
• It is unclear whether the Letter would also mean that medical device wholesalers would be required to obtain a CDAKB certificate before they commence any commercial operation, regardless of whether or not they intend to apply for and obtain product registration.

Conclusion

Business actors that are planning to either invest in or set up a new medical device wholesaler company should consider this new development and factor the process of obtaining a CDAKB certificate into their timeline (especially when they plan to have the medical device wholesaler company become the holder of product registrations). 

Existing non-CDAKB certificated medical device wholesalers that also serve as product registration holders need to carefully monitor this progress and consult with the MOH closely to confirm (i) whether the MOH will adopt any grandfathering treatment for them, and (ii) what rectification or interim model they should adopt to comply with the MOH’s new policy.

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