This section forms the backbone of the certificate; every entry directly determines a product’s market access eligibility in Indonesia.
（一）Two Key Identification Numbers
Indonesian OSS Business Entity Code: Bound to a locally licensed Indonesian importer. Used for customs filing and industrial & commercial qualification verification, it represents the local operating credentials of the license holder.
（二）Product Registration Details
Product Name: Intracranial Thrombus Aspiration Catheter
Risk Classification: Indonesian medical devices are categorized into four risk tiers: Class A, B, C and D. Class D corresponds to Class III implantable/interventional devices in China and undergoes the strictest review and control during registration.
Product Category: Therapeutic neurological device; Indications limited to mechanical thrombectomy for acute ischemic stroke neurovascular treatment.
Specification Marking: Tipe/Ukur marked as Terlampir (See attached annex). All product models and dimensions are listed uniformly in the annex.
（三）Registration Validity Period
Standard AKL registrations are valid for 5 years. Renewal applications must be submitted in advance prior to expiry; expired licenses automatically become invalid, prohibiting further customs clearance, importation and commercial sales of the product.
（四）Role of the License Holder
Indonesian mandatory regulations prohibit overseas manufacturers from holding an AKL certificate directly. Manufacturers must appoint a qualified local Indonesian trading company as the licensed importer (a PB-UMKU affiliated entity). This local license holder acts as the liaison with Indonesian health authorities and bears all statutory local responsibilities, including annual report submission and adverse event management.
三、Non-Negotiable Compliance Clauses Stated on the Certificate
Five legal clauses printed on the certificate represent easily overlooked compliance red lines that directly determine the continued validity of the license.Validity Period Restriction：AKL licenses remain valid for 5 years; failure to renew results in immediate forfeiture of market access rights.Mandatory Reporting Obligations：The Indonesian license holder must submit annual business reports on schedule. Any adverse medical events linked to the product must be reported to the Indonesian Ministry of Health within legally stipulated timelines. Concealment or delayed reporting may lead to license suspension or revocation.Product Ownership Control：Any changes to product trademarks or intellectual property ownership invalidate the original AKL certificate. The old certificate must be returned, and full re-registration is required.Legal Validity of Annexes：The product specification annex marked Terlampir forms an inseparable component of the certificate. Only models listed within the annex may be imported and sold under this license.；Document Correction & Re-Examination Claus：If information declared during registration conflicts with the actual product or manufacturing facility details, Indonesian health authorities reserve the right to conduct a re-examination and revoke the AKL distribution license.四、Certificate Authenticity Verification MethodsUpon receiving a certificate, authenticity verification is the first critical step to avoid counterfeit documentation risks.Issuance Qualification Check: All AKL certificates are generated through Indonesia’s official OSS business system. A footnote confirms the document is certified by BSIE-BSSN, Indonesia’s statutory electronic certification authority, granting electronic certificates equal legal standing to physical paper originals.QR Code Verification: The anti-counterfeit QR code at the bottom left of the certificate links directly to Indonesia’s official OSS regulatory database. Scanning enables one-click verification of all data including certificate number, product information, licensee and validity period, making it the fastest authenticity check channel.Complete Record Retrieval: Authorized corporate accounts may log into the OSS system to access full product registration archives, cross-checking original filed data such as manufacturer details, device classification and registration parameters.五、Critical Compliance RemindersObtaining the AKL certificate is not the finish line; sustained regulatory compliance is paramount. Keep the following key points in mind:- Always obtain the full certificate package including the original document and product specification annex. Missing annexes create ambiguity over compliant product scopes and frequently lead to customs detention of shipments.
- Prepare AKL renewal documentation 6–12 months before expiry to allocate sufficient time for regulatory review, preventing gaps in licensing that disrupt import shipments.
- Any modifications to product models, manufacturing addresses, raw materials or other core attributes must be pre-reported to the Indonesian Ministry of Health by the local license holder. Sales and importation may only resume after official approval of the change application.
- Regularly monitor the local Indonesian license holder to ensure timely submission of annual reports and adverse event disclosures. Partner non-compliance may result in revocation of your product registration certificate.
- Verify the PB-UMKU entity status of your Indonesian importer at the early cooperation stage to confirm valid operating qualifications and mitigate compliance risks arising from unqualified intermediaries.
