DR Congo ACOREP Register: China's 51% Share and Local Agent Lock-in

Sub-Saharan Market Access: Decoding the ACOREP Medtech Registry

For global regulatory affairs and market-access professionals targeting Sub-Saharan Africa, the regulatory landscape is often perceived as opaque and fragmented. While the East African Community (EAC) has attempted to harmonize registration procedures, and Southern African nations have established distinct national registers like the Zambia ZAMRA medical device registry or the Kenya PPB medical device registry, Central French-speaking Africa has historically remained a blank spot for quantitative regulatory analysis.

The Democratic Republic of the Congo (DRC) represents one of the largest and most populated nations in Africa, making it a critical, high-volume healthcare market. However, navigating the legal requirements for medical hardware in the DRC requires understanding a system that is currently transitioning from legacy colonial models to a modern, independent regulatory agency framework.

The competent authority responsible for health product oversight in the DRC is the Autorité Congolaise de Réglementation Pharmaceutique (ACOREP). Established on 5 March 2020 by Decree No. 20/002 (under the Prime Minister's office, placed under the tutelage of the Minister of Public Health), ACOREP replaced the legacy Direction de la Pharmacie et du Médicament (DPM). The agency operates under the authority of the Ministry of Public Health (Ministère de la Santé Publique, Hygiène et Prévoyance Sociale) and regulates medical devices under the same marketing authorization (Autorisation de Mise sur le Marché or AMM) framework historically used for pharmaceutical products.

For foreign manufacturers, understanding how ACOREP evaluates and lists medical devices is critical. In this data teardown, we analyze the official ACOREP medical device database to quantify import dependencies, identify local representative (agent) concentration, highlight unique product categories, and explain the step-by-step regulatory workflow. We also compare this framework to neighboring markets like the Tanzania TMDA medical device registry and others.

Scenario Question:

We are a medical device manufacturer planning to enter the Democratic Republic of the Congo — what are the requirements under ACOREP, who dominates the registry, and how does the local representative model work?

Direct Answer:

Under ACOREP, all medical devices and in vitro diagnostics (IVDs) must obtain a formal marketing authorization (AMM) to be legally imported, distributed, and used in the DRC. The registration is valid for 5 years and requires the appointment of a registered Congolese distributor as your Local Authorized Representative (AR).

Our quantitative analysis of the primary ACOREP medical device database (representing 461 active authorized medical device records as of July 2026) reveals the following key metrics:

• Extreme Import Dependency: 95.2% of all registered medical devices (439 records) in the DRC are imported from foreign countries. Only 4.8% (22 records) are produced locally, reflecting a near-complete reliance on international supply chains for sterile medical hardware.
• China and India Dominance: Two countries account for more than three-quarters of the entire registry. China leads with 51.4% (237 records) of all registrations, followed by India with 25.6% (118 records). The remaining imports are fragmented across Malaysia (3.7%), Pakistan (3.5%), Angola (2.2%), Vietnam (1.5%), Switzerland (1.3%), and the United States (1.1%).
• Centralized Representative Concentration: Local distribution channels are highly centralized, creating significant lock-in risk for foreign makers. Five local agents control 43.7% of all medical device registrations (201 records): Unique Pharma (46 records, 10.0%), Phatkin (45 records, 9.8%), Prince Pharma (42 records, 9.1%), Pharmex (35 records, 7.6%), and New Cesamex SARL (33 records, 7.2%).
• Basic Consumables Focus: The register is dominated by basic medical consumables rather than complex diagnostic or surgical hardware. Bandages, gauze, and wound dressings make up 21.3% (98 records), and syringes, needles, and scalp vein sets account for 14.1% (65 records).
• The "Dispositif Antipaludique" Signal: Uniquely, long-lasting insecticidal bed nets (LLINs) are regulated and registered as medical devices (Dispositif antipaludique) under the AMM system. These nets account for 10.6% of the entire registry (49 records), reflecting the national public health priority of malaria prevention.
• Reliance Pathway: ACOREP utilizes a reliance model. It does not perform independent clinical reviews but accepts premarket approvals from recognized reference authorities, requiring a Certificate of Free Sale (CFS) or Certificate for Foreign Government (CFG) alongside ISO 13485 certification.

The ACOREP Regulatory Framework: A Transition to Modern Oversight

Historically, medical device regulation in the DRC was managed on an ad-hoc import clearance basis by the DPM. The establishment of ACOREP in 2020 represented a strategic shift toward a semi-autonomous regulatory agency model, designed to align the DRC with World Health Organization (WHO) Global Benchmarking Tool standards and the African Medicines Regulatory Harmonization (AMRH) initiative.

ACOREP’s mandate covers the full product lifecycle for health products:

1. Marketing Authorization (AMM): Evaluation and registration of medical products, including devices, prior to market entry.
2. Import and Export Licensing: Issuing import authorizations (Autorisation Spéciale d'Importation) for registered products.
3. Establishment Licensing: Registration and licensing of pharmaceutical and medical device manufacturing plants, local representatives, and wholesalers.
4. Market Surveillance: Inspection, quality testing, pharmacovigilance, and materiovigilance.

The AMM System for Medical Devices

Under the Congolese public health code, medical devices are defined as instruments, apparatus, appliances, materials, or other articles, used alone or in combination, intended for humans for medical purposes (diagnosis, prevention, monitoring, treatment, or alleviation of disease).

Unlike other jurisdictions that separate drug and device registries, ACOREP lists medical devices within its broader Répertoire des Autorisations de Mise sur le Marché. This integration means that devices are subject to similar administrative review queues as pharmaceuticals, including:

• A formal application fee (varies by device classification).
• Review by ACOREP technical committees.
• A 5-year expiration cycle, requiring a renewal dossier submission at least six months before expiration.

The Registration Pathway: Step-by-Step for Foreign Manufacturers

Foreign medical device manufacturers without a physical office in Kinshasa or another DRC province cannot submit registration files directly to ACOREP. They must execute the process through a designated local representative.

+-------------------------------------------------------+
|        Foreign Manufacturer prepares dossier          |
|    - ISO 13485, CFS/CFG, Technical Dossier, Labels     |
+-------------------------------------------------------+
                           |
                           v
+-------------------------------------------------------+
|     Appoints licensed Local Authorized Representative  |
|          - Notarized Power of Attorney (PoA)          |
+-------------------------------------------------------+
                           |
                           v
+-------------------------------------------------------+
|            Local Rep submits file to ACOREP           |
|         - Pay administrative registration fee         |
+-------------------------------------------------------+
                           |
                           v
+-------------------------------------------------------+
|              ACOREP Technical Evaluation              |
|        - Reliance check on reference approvals        |
+-------------------------------------------------------+
                           |
                           v
+-------------------------------------------------------+
|      AMM Issued (5-Year Validity, listed in Register) |
+-------------------------------------------------------+
                           |
                           v
+-------------------------------------------------------+
|   Importer applies for Special Import Authorization   |
|                 per shipment via Portal               |
+-------------------------------------------------------+

Step 1: Appointment of a Local Representative (AR)

The local representative must be a pharmaceutical or medical device establishment licensed by ACOREP to distribute health products in the DRC. Foreign manufacturers must sign an exclusive or non-exclusive representation agreement and provide a notarized Power of Attorney (PoA).

[!WARNING] Because local representatives are responsible for the regulatory file and must sign off on import licenses, selecting the right partner is critical. If a manufacturer wishes to change distributors, they must obtain a formal release letter from the existing representative or request ACOREP to transfer the AMM, which can lead to prolonged market access disputes and "distributor lock-in."

Step 2: Dossier Preparation (French Translation)

While ACOREP accepts technical files in English for complex components, the primary administrative documentation, labels, instructions for use (IFU), and patient brochures must be in French, which is the official language of the DRC. The dossier must include:

• Manufacturer Information: Site location, ISO 13485 certification.
• Product Specifications: Raw materials, design, packaging, sterilization method.
• Regulatory Status: Evidence of approval in the country of origin, plus Certificate of Free Sale (CFS) or Certificate for Foreign Government (CFG).
• Clinical Studies: Summaries of clinical evaluations (for high-risk devices).
• Stability and Shelf Life: Validation data, particularly for sterile consumables or IVD reagents.

Step 3: Submission and Administrative Fees

The local representative submits the dossier to ACOREP’s offices in Kinshasa or via their evolving digital portal. The submission is accompanied by payment of the registration fee. Fees are set in USD but payable in local currency (Congolese Franc, CDF) or USD via authorized commercial banks. Registration fees are non-refundable, even if ACOREP rejects the application.

Step 4: Special Import Authorization

Once a device is listed in the ACOREP register, each individual commercial shipment requires a Special Import Authorization (Autorisation Spéciale d'Importation). The local importer must submit the invoice, bill of lading, and the product's valid AMM certificate to ACOREP to obtain customs clearance.

Quantitative Teardown: What the ACOREP Medical Device Database Shows

To understand the market dynamics and product mix in the DRC, we conducted a quantitative analysis of the active medical device registrations in the ACOREP registry database. The database contains 461 active records spanning the period from 2021 to 2025.

Country of Origin: Overwhelming Dominance of Asian Manufacturers

Our analysis reveals an extreme geographic concentration of device supply. Imported medical devices account for 95.2% (439 records) of the register. More importantly, two Asian manufacturing giants—China and India—supply 77.0% of all medical devices registered in the DRC.

Data Source: ACOREP Répertoire des Autorisations de Mise sur le Marché (AMM register), snapshot July 2026.

This distribution highlights the price-sensitive nature of the DRC healthcare market. Basic medical consumables are sourced primarily from low-cost, high-volume manufacturers in China and India. High-value European and American medical technologies (such as active implants or advanced imaging systems) represent a tiny fraction of the active registrations, often entering the country through specialized donor-funded programs or direct ministry procurement exemptions that bypass standard registry listing.

Local Manufacturing: Basic Hygiene and Plastic Consumables

Only 4.8% (22 records) of the registrations represent domestic production. An inspection of these 22 records reveals that local manufacturing in the DRC is restricted to basic hygiene and disposable plastic items:

1. Cato International S.a.r.l. (Kinshasa): Registers local production of sterile plastic syringes (2 mL, 5 mL, and 10 mL) distributed through Prince Pharma.
2. Laboratoire PHATKIN (Kinshasa): Registers sterile scalp vein sets (Epicranien G24) for local distribution.
3. Afro Medical S.A.R.L. (Kinshasa): Registers locally manufactured syringes (2 mL, 5 mL, and 10 mL).
4. Beltexco (Kinshasa): A major local trading company that manufactures hygiene products, registering local sanitary pads (Diva Princesse, Diva Regular, Diva Super) and baby diapers (Bambi).
5. Unity Manufacturing S.A.R.L. (Kingabwa, Kinshasa): Registers baby diapers under the brands BB Cool, Smart, and VIP Baby (Taille S, M, L).

Beyond these basic items, there is no domestic manufacturing of advanced therapeutic, diagnostic, or implantable devices in the DRC. Foreign manufacturers face no local competition for complex hardware, but they must compete intensely on price for high-volume consumables.

Local Representative Concentration: High Distributor Lock-in Risk

A critical finding of our database analysis is the extreme concentration of registrations held by a small group of local agents. Under ACOREP regulations, the applicant listed on the AMM registry is the importer or local representative, not the foreign manufacturer. Across the 461 active device records, only 52 distinct local representatives appear as AMM applicants — and the top five of them hold 43.7% of all medical device registrations (201 records).

  [ACOREP Medical Device Registry - Local Agent Share]
  
  +-------------------------------------------------------+
  |  Unique Pharma (10.0%)                                |
  +-------------------------------------------------------+
  |  Phatkin (9.8%)                                       |
  +-------------------------------------------------------+
  |  Prince Pharma (9.1%)                                 |
  +-------------------------------------------------------+
  |  Pharmex (7.6%)                                       |
  +-------------------------------------------------------+
  |  New Cesamex SARL (7.2%)                              |
  +-------------------------------------------------------+
  |  Remaining 47 Agents (56.4%)                          |
  +-------------------------------------------------------+

This high level of channel concentration has direct strategic implications:

• Negotiation Leverage: The dominant local agents (Unique Pharma, Phatkin, Prince Pharma) hold massive portfolios of registrations. They possess significant leverage in negotiating distribution margins and exclusivity clauses.
• Transition Barriers: Because the registry files are tied to the local representative, transferring a product registration to a new agent is complex. A foreign manufacturer who falls out with a top-five agent may find their product blocked from the market for years while the AMM remains registered under the legacy agent's name.
• Regulatory Compliance: Working with a major agent ensures that the firm has experience with ACOREP's administrative processes, but it requires careful contractual drafting to preserve intellectual property and marketing rights.

Product Category Distribution: The "Dispositif Antipaludique"

A unique aspect of health product classification in the DRC is the inclusion of long-lasting insecticidal nets (LLINs) in the medical device registry. While many countries regulate these nets as agricultural chemicals or general textiles, ACOREP classifies them as anti-malaria medical devices (Dispositif antipaludique) because they are impregnated with insecticides (such as Deltamethrin or Permethrin) and are primarily distributed as a public health intervention to prevent malaria.

Our analysis of the product categories in the registry highlights this unique mix:

Data Source: ACOREP Registry Analysis, July 2026.

Anti-malaria nets account for 10.6% of the active registry (49 records). Leading global brands like Permanet Dual (manufactured by Vestergaard Frandsen) and SafeNet Plus are formally listed in the register. For public health procurement agencies (such as the Global Fund or USAID), verify that your netting suppliers have obtained ACOREP AMM listing before launching tender shipments into the DRC.

Registration Time Trends: Post-Establishment Registry Surge

Analyzing the registration dates in the database shows that ACOREP conducted a major registration campaign shortly after its launch to update and formalize the status of medical devices on the market.

• 2021: 115 registrations (Initial post-DPM transition audit)
• 2022: 179 registrations (Peak registration wave, clearing legacy files)
• 2024: 101 registrations (Post-COVID-19 normalization)
• 2025: 66 registrations (Current active pipeline)

(Note: The registry did not record medical device listings in 2023 due to an agency internal restructure and system migration, which was subsequently resolved in early 2024).

The decline in annual registrations from 179 in 2022 to 66 in 2025 does not indicate a shrinking market, but rather the stabilization of the database after ACOREP cleared the backlog of legacy DPM submissions.

Comparative Analysis: DR Congo vs. Regional African Peers

For global regulatory strategy, it is useful to contrast DR Congo’s ACOREP framework with other Sub-Saharan registries. The table below compares the DRC with its neighbors, drawing on our previous analyses of the Kenya PPB retained medical devices teardown and the Zambia ZAMRA medical device registry:

DR Congo stands out for the sheer dominance of a single source country: China holds over half (51.4%) of all active registrations, a concentration not seen in Kenya or Zambia, where supply is split across China, India, Thailand, and Western manufacturers with no single country exceeding roughly a quarter of the register (Zambia's leading source, India, sits at 22.6%). Furthermore, the mandatory requirement for French-language labeling represents a significant administrative barrier for foreign manufacturers accustomed to shipping English-labeled boxes — a barrier absent in the English-speaking Kenyan and Zambian markets.

FAQs: Navigating DR Congo Medical Device Compliance

Do medical devices require local clinical trials or testing in the DRC?

No, ACOREP does not require local clinical trials for standard medical devices or IVDs. Under its reliance model, ACOREP accepts clinical data and premarket approvals from recognized reference countries, including the US FDA, European Union Notified Bodies, Health Canada, or Japan's PMDA. However, for novel diagnostics (such as rapid tests for local infectious diseases), ACOREP may require validation testing to be performed by the national reference laboratory (Institut National de Recherche Biomédicale - INRB) in Kinshasa prior to issuing the AMM.

How long is an ACOREP medical device registration valid, and is there an annual fee?

ACOREP registrations (AMMs) are valid for 5 years from the date of issuance. Unlike Kenya, which requires annual retention fee payments to keep registrations active, ACOREP does not charge annual maintenance fees. However, manufacturers must submit a renewal dossier at least six months before the 5-year expiration date. The renewal dossier must confirm that the device design and manufacturing site have not changed, and must include updated ISO 13485 and CFS certificates.

Why are insecticidal bed nets registered as medical devices in the DR Congo?

ACOREP classifies long-lasting insecticidal nets (LLINs) as medical devices (Dispositif antipaludique) because they serve a primary medical purpose: preventing the transmission of malaria by providing a physical and chemical barrier against Anopheles mosquitoes. Because malaria is a leading cause of mortality in the DRC, regulating these nets under the health product framework ensures that all distributed nets meet strict standards for insecticide concentration, net mesh size, and wash resistance.

Can a foreign manufacturer appoint multiple local representatives in the DRC?

Yes, technically ACOREP allows a manufacturer to register products through multiple local representatives if they hold non-exclusive agreements. However, in practice, because the AMM registration certificate is issued to a specific applicant (the local rep), registering the same product catalog numbers through multiple distributors requires submitting separate dossiers and paying separate registration fees for each agent. Therefore, most foreign manufacturers opt for a single exclusive local representative who manages the regulatory portfolio and coordinates sub-distribution agreements with secondary dealers.

Conclusion: Strategic Recommendations for Market Entry

The Democratic Republic of the Congo represents a high-volume, import-reliant market that offers significant commercial opportunities, but navigating ACOREP requires a structured regulatory strategy. If you are preparing to enter the DRC market, consider the following recommendations:

1. Draft Power of Attorney Agreements Carefully: Ensure your contract with the local representative includes clear clauses regarding the ownership of the AMM registration. The contract should stipulate that if the distribution agreement is terminated, the local representative must cooperate in transferring the registration file to a new agent at no cost.
2. Ensure French Compliance Early: Do not wait for ACOREP feedback to translate your labels, packaging, and instructions for use. Establish a French-language translation workflow during the initial dossier compilation phase.
3. Validate Net/Consumable Status: If you manufacture public health products like insecticidal nets, rapid tests, or syringes, confirm that your products are listed in the ACOREP register before bidding on public tenders. Unregistered devices will be blocked at the border, even if imported by humanitarian or international organizations, unless a special emergency waiver is granted by the Minister of Health.
4. Leverage Reference Approvals: Maintain active CE certificates or FDA clearances. ACOREP's reliance pathway is fast when backed by robust reference approvals, but applications without foreign government certification will face extensive delays and technical queries.

Disclaimer: This guide is for educational purposes only and does not constitute formal legal or regulatory advice. Regulatory requirements under DR Congo's ACOREP change frequently. Consult a qualified regulatory professional or local legal counsel before initiating registration dossiers in the DRC.