Medical Device License Amendment in Indonesia

License Maintenance is an important consideration for manufacturers selling medical devices in Indonesia as failure to comply could lead to loss of market access and significantly affect sales. Medical Device License Amendments in Indonesia consists of renewing every 5 years, maintaining halal compliance, and obtaining approval prior to importing products that have changed from the originally approved License(s).

Amendments

Acceptable amendments are described in the Decree of Ministry of Health’s No. 62 /2017 (article no. 30) which permits the following types of amendments:

• Packaging dimension
• Packaging size
• Labeling
• Product stability (temperature and expiry)
• Product codes
• Product numbers
• Distributor(s)
• Tax ID number
• Some product sizes

All other changes would likely require a new registration submission.

Amendment fees are IDR 1,000,000 (US$ 65-70) and are typically approved within 3 months.

Renewing Licenses

License Renewals adhere to guidance outlined in No. 62 /2017 Article 26 and should be submitted at least 9 months before the expiration. Distribution activity will need to be submitted through the E-Report system as part of the process and the fees are IDR 1,000,000 (US $65-70) per product.

The license renewal can be included with the amendment license (in a single application) with government fees of IDR 1,500, 000. Renewal or amended is only IDR 1,000,000. Amendment and renewal process will be 10-15 working days.

Halal Requirements

Manufacturers should also stay informed on the evolving Halal requirements to ensure

For the time being and until October 17, 2021, when the grace period begins, Asia Actual is advising medical device manufacturers to abide by the following 3 conditions when considering whether to market your product as Halal.

• 1st Condition: Products containing animal, plant, microbe or process material must undergo Halal certification and will bear the “HALAL” logo upon certification.
• 2nd Condition: Products that do not meet Halal standards should be labeled appropriately as a “Non-Halal Product.”
• 3rd Condition: Products that do not contain and have never been contaminated by animal materials are not required to seek Halal Certification according to Indonesian Ulema Council’s (MUI) positive list (list and label has not yet been defined)

For the majority of medical device manufacturers, the 3rd Condition will apply and therefore, they will not need Halal certification at this time, but may need to adjust their labeling down the road once the official regulations have been implemented. While some products are obviously Non-Halal like porcine heart valves or bone substitutes in dental applications, certifying that the entire manufacturing process is Halal can be tricky, especially when it comes to coatings and product impregnation techniques.

Once implemented, Asia Actual will be able to provide support during the initial review of manufacturing facilities along with providing contact information for BPJH (Halal Product Assurance Agency) approved Halal certification agencies.

Changes – Interpretations of permissible modifications can vary and it’s important to always check with your License Holder or Regulatory Professionals when considering new changes to maintain compliance and avoid losing market access.

Contact Asia Actual with any medical device license amendment questions in the Indonesia. Our local, bi-lingual regulatory experts are well positioned to assist.