Costa Rica Medical Device Registration: 20 FAQs on RTCR 505 Classification, CLV and Timelines (2026)

Costa Rica’s market is not large, but its regulatory structure is complete, the review process is fully digital, and it applies a four-class risk classification of the same origin as Canada’s – making it the most common first landing point for Chinese medical device companies entering Central America.

Executive Decree No. 43902-S, signed on 30 November 2022, approved RTCR 505:2022 “Biomedical Equipment and Materials: Classification, Registration, Import, Labeling, Advertising, Vigilance and Control”, replacing the substance of the old 2008 regulation No. 34482-S and consolidating classification, registration, import, labeling, advertising, vigilance and control into a single technical regulation; in January 2024 an amendment adjusted the certificate of free sale (CLV) and equivalency mutual recognition provisions.

This guide has been compiled from the official regulatory texts, 20 questions on Costa Rica market access and gives the legal basis for each one.

1. Regulatory framework: first clarify who regulates and under what

Q1. Who regulates medical devices in Costa Rica, and what are the core regulations?

Answer: The competent authority is the Ministry of Health of Costa Rica (Ministerio de Salud). In Costa Rican regulation, medical devices are not called “medical devices”; they are called biomedical equipment and materials (Equipo y Material Biomedico, EMB).

The regulatory hierarchy has four levels:

Legal basis: preamble of Decree 43902-S (citing Articles 1, 2, 4, 7, 49 and 142-145 of Law 5395), Articles 1, 3.1-3.4 and 10.1.

Q2. Where are the boundaries of the EMB definition? Do software, aesthetic devices and cosmetic contact lenses count?

Answer: The definition in Article 4.25 is: any instrument, apparatus, machine, device, material or other article, used alone or in combination (including software involved in its normal operation), intended by the manufacturer for human beings, to achieve diagnosis, prevention, control, treatment or alleviation of disease; diagnosis, control, treatment, alleviation or compensation of injury and disability; investigation, replacement or modification of anatomy or of physiological processes; or regulation of fertility – and whose principal intended action is not achieved by pharmacological, immunological or metabolic means.

Costa Rica’s definition is broader than that of most markets and expressly includes four categories of easily overlooked products:

• Medical software and mobile apps (Article 4.59 lists “Software como Equipo Medico” separately, including apps that act as accessories of an EMB and apps that turn a general-purpose mobile platform into a regulated device);
• Aesthetic medicine treatment devices;
• Contact lenses without corrective function (i.e. “cosmetic” colored lenses);
• Instruments used for permanent or semi-permanent microblading and tattooing, and tools that operate through invasive techniques or skin piercing.

Legal basis: Articles 4.25, 4.59 and 4.2.

Q3. Which products are excluded from this regulation?

Answer: Article 2.2 lists the exclusions: medicines; human blood, blood products, plasma and human blood cells; cosmetics; human organs, tissues, cells and their derivatives (and products manufactured from them); general laboratory supplies or supplies for research use only (unless the manufacturer explicitly designates them for in vitro diagnostic use); certified reference materials; materials for external quality assessment schemes; and medical gas piping systems assembled on site in healthcare facilities and permanently integrated into the building structure.

One more point that is easy to misjudge: customs clearance authorizations applied for so that unregistered EMB can be used in clinical studies only are likewise outside the scope of this regulation (Article 2.2.9); that pathway belongs to clinical trial regulation, not commercial registration.

Legal basis: Article 2.2 (including 2.2.1-2.2.9).

Q4. Are drug-device combination products filed as devices or as drugs?

Answer: Article 2.3 sets out a three-step test:

• Devices intended to administer medicinal substances: the device part is governed by this regulation, and the medicinal substance must be registered separately under the Central American technical regulation on drug registration;
• If the product and the medicinal substance form a single integral unit that is indivisible, dedicated and not reusable, the whole product is governed by the drug technical regulation;
• Drug-eluting coated catheters, antimicrobial dressings, pre-filled syringes and the like must first be assessed as “device-led” or “single integrated product”, because the two pathways differ in dossier structure and competent office.

Legal basis: Article 2.3.

2. Classification: do not copy EU or FDA classes

Q5. How many classes are there, and where do the classification rules come from?

Answer: There are four risk classes, Class 1 to Class 4, with Class 1 the lowest risk and Class 4 the highest (Article 8.1). Where a product can fall into more than one class, the highest class applies. The rules are in Annex A: A.1 for general EMB (rules 1-16) and A.2 for in vitro diagnostics (rules 1-9).

This rule system is partly consistent with Canada’s Medical Devices Regulations SOR/98-282 (Article 23, “Concordancia”, expressly states “partial conformity”). Article 8.3 provides a further channel: for products not covered by the rules, the Ministry of Health determines the class by administrative decision and incorporates it into the regulation.

Practical reminder: the class must be derived rule by rule under Annex A, and the applicable rules and reasoning must be stated in the application dossier. Directly copying EU MDR Class IIa/IIb or FDA Class II is the most common source of classification errors.

Legal basis: Articles 8.1, 8.2, 8.3 and 23, and Annex A.

Q6. Give some classification outcomes for high-frequency products

Answer: The following outcomes are all derived by applying the Annex A rules; the Ministry of Health’s review prevails:

Note: for the same hardware, a different statement of intended use can change the class entirely. Classification is not a property of the product but a function of “product + intended use”.

Legal basis: Annex A.1 rules 1, 9 and 16; A.2.3 rules 6 and 8.

Q7. Class 1 needs no registration – does that mean nothing has to be done?

Answer: No. The wording of Article 2.4 is: Class 1 may be commercialized and used without health registration, but import, labeling, advertising, vigilance and control requirements still apply.

Three obligations are often overlooked:

• The importing entity must still hold a valid sanitary operating permit matching the activity “import of EMB” – the definition of “importer” in Article 4.42 itself presupposes that permit;
• Labels must still meet the 18 elements of Article 19;
• Advertising must still be authorized under Article 20, and unregistered products must not be advertised.

In addition, Article 22.2 preserves the power to correct: if the Ministry of Health has reasonable grounds to believe that a product is being imported or sold as Class 1 but does not actually belong to that class, it may require the holder to submit documentation to re-determine the class.

Legal basis: Articles 2.4, 19, 20 and 22.2.

3. Registration parties: three roles that must be kept apart

Q8. Must the registration holder be a Costa Rican company?

Answer: The regulation does not require the holder to be a Costa Rican company, but it does require three roles to be in place:

• Product holder (titular del producto, Article 4.60): the owner legally responsible for the product, which may be the foreign manufacturer itself;
• Legal representative (representante legal, Article 4.56): must be domiciled in Costa Rica, appointed by the holder through a power of attorney authenticated/apostilled, and legally accountable to the Ministry of Health;
• Importer (importador, Article 4.42): must hold a valid sanitary operating permit (permiso sanitario de funcionamiento) matching the import activity; the Ministry of Health verifies this permit internally (Article 10.4).

At the distributor level, Article 10.11 allows the holder, in the registration application or through a post-registration change, to authorize third parties to import or distribute; Article 18.8 lists adding or changing distributors as a change matter.

Conclusion: although the regulation does not require a local company as holder, a local legal representative and a licensed importer are mandatory; distributors can be added or replaced under the same registration number – this is exactly the commercial value of the “independent holder” structure.

Legal basis: Articles 4.42, 4.56, 4.60, 10.3, 10.4, 10.11 and 18.8.

Q9. Can multiple models, main units and accessories go on one certificate?

Answer: Article 10.7 allows seven situations to be merged into one application and one registration number, and states clearly that “one application is charged once”: multiple specifications or presentations of the same product; dilutions of the same pure substance at different concentrations (CAS number and hazard classification unchanged); one test kit; one EMB family (familia); one EMB group (grupo); a family of groups (familia de grupos); and systems (sistemas).

Three sets of definitions determine the boundaries of the merge:

• Family (Article 4.37): same manufacturer, same design, same manufacturing process and same intended use, differing only in shape, color, flavor or size;
• Group (Article 4.40): a set of EMB placed on the market together by the manufacturer for a specific operation; the components may differ and may even come from different manufacturers;
• System (Article 4.58): marketed under one name, with components jointly performing all or part of the function; components of the same manufacturer must be registered together, and components of other manufacturers must be registered separately.

Accessories are covered by Article 7.6: an accessory that can be used across multiple models may be registered separately, and its class may differ from that of the main unit; an accessory dedicated to one main unit may be registered together with it.

Article 10.8 sets a red line: similar products with different compositions must be registered separately.

Legal basis: Articles 10.7, 10.8, 4.37, 4.38, 4.40, 4.58 and 7.6.

4. Dossier: the real differences between Class 2, Class 3 and Class 4

Q10. What is the complete document list for Class 2?

Answer: Articles 11.1-11.11 list 11 items:

• Registration application form (published via Registrelo, digitally signed);
• Domestic products: sanitary operating permit of the premises, with the activity covering “manufacture of EMB”;
• Imported products: certificate of free sale (CLV), authenticated/apostilled with an official translation attached;
• Manufacturer’s technical and medical specifications, manuals and instructions for use: the technical information must cover the 12 items a-l of 11.4.1 (product description and identification code, an image of each product, instructions for use, component composition, materials, single-use or reusable, sterile or not together with the validation report of the sterilization method, whether sterilization is needed before use, whether for individual use, conditions of use and maintenance, storage and transport conditions, and the safety data sheet and qualitative formulation for IVD reagents); the medical information must cover the 6 items a-f of 11.4.3 (intended use and indications, information on any medicinal substances contained, precautions for use, patient information, possible complications, contraindications);
• Manufacturer’s BPM certificate or equivalent document, covering the one or more sites involved in design and development, production, warehousing and distribution, installation and technical support;
• For products using ionizing radiation, authorization for the radiation source (issued by the Ministry of Health’s radiation protection and environmental health authority);
• Original label; if it is not in Spanish or elements are incomplete, a supplementary label proposal;
• Contract manufacturing agreement (if manufactured by a third party), which must contain the elements of 11.8.1-11.8.7: signatures of both parties, BPM commitment, production and analysis conditions, handling of raw materials and finished products, audit rights, product list, complete information of both parties and validity period;
• Power of attorney (poder), requirements in Q13;
• Proof of payment of fees;
• For IVDs, additionally a document justifying the applicable accuracy and precision standards (international standards).

Legal basis: Articles 11.1-11.11.

Q11. What must Class 3 and Class 4 add?

Answer: Class 3 (Articles 12.1 and 12.2) adds a clinical evidence package on top of the full Class 2 dossier: the manufacturer’s clinical evaluation report; preclinical studies (where applicable); clinical studies in humans – if the product is mature technology and the manufacturer has not conducted its own clinical studies, third-party literature on the product or an equivalent product may be submitted, together with an equivalency statement and supporting evidence issued by the manufacturer; software validation (where applicable); literature review; and a summary of the risk analysis.

Class 4 (Article 13.1) adds three more items on top of Class 3: copies of the documents on risk management analysis and risk reduction measures; published literature on post-market use, safety and performance of the product; and a biosafety certificate for products of animal tissue origin and their derivatives.

IVDs of Class 3 and Class 4 have their own channel: Articles 12.3, 12.4 and 13.2 allow part of the clinical evidence to be replaced by “comparative studies using representative human samples under conditions close to the intended conditions of use”, with a statement from the holder attesting the truthfulness of the results.

Legal basis: Articles 12 and 13.

Q12. The seven most common pitfalls with the certificate of free sale (CLV)

Answer: The CLV is the single document with the highest rejection rate; the problems concentrate on seven points:

• Issuing body: it must be the “competent health authority” (Article 4.7); certificates of sale issued by chambers of commerce or industry associations are not accepted;
• Names and codes: the CLV and the application documents must clearly show the manufacturer’s name, the product name and the identification code; where there is no code, the model and a detailed description must be given (Article 10.19);
• The authority does not list codes: a product list issued by the manufacturer or holder and endorsed by the health authority may be attached (Article 10.19);
• The authority neither lists codes nor endorses: a letter from the authority stating that it “will not list” them must be submitted, or a statement issued by the holder/legal representative quoting the relevant provisions of the regulation and the website where they can be consulted, with an official translation attached (Articles 10.19 and 10.22);
• Authentication chain: foreign public documents must be authenticated or apostilled, with notarized authentication of digital signatures; official documents must have official translations (Articles 10.13 and 10.17);
• Validity: where no validity period is stated, it is counted as 2 years from the date of issue (Article 10.15);
• No alterations: corrections to the certificate are not accepted unless issued by the original issuing authority (Article 10.16).

The 2024 amendment added an important flexibility: where the product is manufactured by a third party or a subsidiary and is not marketed in the country of manufacture, the CLV may be issued by the competent authority of the country of the holder, of the country where the holder’s subsidiary is established, or of the country of the parent company’s subsidiary – provided that the subsidiary is legally established in the issuing country and a declaration signed by the legal representative of the parent company is submitted. This gives Chinese manufacturers a clear basis for obtaining the CLV through overseas subsidiaries.

Legal basis: Articles 4.7, 10.13, 10.15, 10.16, 10.17, 10.19, 10.20 and 10.22; 2024 amendment (Article 1 amending Articles 4.7 and 10.20).

Q13. Why is the power of attorney (poder) rejected again and again?

Answer: Article 11.9 requires: a clear validity period and scope of authorization; if executed in Costa Rica, conformity with the Civil Code or the Commercial Code; if executed abroad, conformity with the law of the executing country, stating “who is the legal representative before the Ministry of Health” and that person’s powers, with authentication/apostille, official translation and notarized authentication of digital signatures. Article 10.3 adds: where the holder does not reside in Costa Rica, a legal representative domiciled in Costa Rica must be appointed by power of attorney.

The main reason for rejection is a scope of authorization that is too narrow – stating only “handle the registration” without covering renewal, post-registration changes, fee payment, collection of the certificate and appointment of distributors. It is advisable to cover the full life cycle in one power of attorney. Article 18.4 provides that replacing the legal representative only requires a new power of attorney and is a lighter change.

Legal basis: Articles 10.3, 11.9 and 18.4.

Q14. What exactly are the language and labeling requirements?

Answer: Three layers:

• Application documents: all must be submitted in Spanish; non-Spanish documents need a translation; official or legal documents need an official translation – issued by a translator formally appointed and authorized by the Ministry of Foreign Affairs, with public credibility (Articles 4.61 and 10.13).
• Labels: the manufacturer’s original label, containing 18 items of information in Spanish (Articles 19.1.1-19.1.18): product name, intended use, names and countries of the holder and the manufacturer, identification code or model, lot number, description of packaging contents, expiry date or shelf life, sterile marking, special storage and transport conditions, symbols and warnings, instructions for use or where they are located, whether for individual use, whether single-use, custom-made device marking, the warning statement for IVD self-tests, the registration number (except where registration is exempt), and so on.
• Supplementary labels (Article 4.30): for translation or for supplementing missing mandatory information only; they must not be used to change or correct the content of the original label, and must be firmly attached and not easily removable. Article 19.3 further requires that instructions for use and manuals accompanying the product be in Spanish.

Legal basis: Articles 4.30, 4.61, 10.13 and 19.

Q15. Is the BPM certificate actually required now?

Answer: This question needs a precise answer, because the regulation itself builds in a transition.

Article 11.5 requires the manufacturer’s BPM certificate or an equivalent document; Articles 16.5, 18.9.2, 18.11.1 and 18.16.3 make the same requirement at renewal and for changes. But transitional provision I states clearly that until Costa Rica issues a specific BPM regulation for EMB, the certificate is not mandatory; transitional provision IV requires the Ministry of Health to issue that specific regulation within 12 months of this regulation entering into force.

As of the writing of this article, whether that specific regulation is in force must be confirmed against the Ministry of Health’s current announcements. This also means the same application may get different answers at different submission windows.

Practical advice: submit it if you can, and attach an equivalency statement – stating that the certificate was issued by the health authority of the country of origin or its authorized body and that its scope matches the product. Whether an ISO 13485 certificate issued only by a commercial certification body counts as an “equivalent document” depends on whether it is an equivalent proof recognized by the country of origin, and should not be presumed.

Legal basis: Articles 11.5, 16.5, 18.9.2, 18.11.1 and 18.16.3; transitional provisions I and IV.

5. Timelines, fees and equivalency mutual recognition

Q16. How long does the review take? How much does it cost?

Answer: It is necessary to distinguish between “what the regulation says” and “how long the project actually takes”.

At the regulatory level: RTCR 505 itself sets no overall review time limit; Article 14 points the review periods for registration, renewal and changes to Executive Decree No. 37988-S (the Registrelo portal regulation). The only hard deadline expressly stated in the RTCR concerns notification-type post-registration changes: approval or rejection within at most 5 business days from receipt of the application (Article 5 of Decree 43902-S, amending Article 34.2.4.1 of 37988-S). Based on industry registration experience, routine low-risk registrations take about 6 months, high-risk products 12 to 18 months, and a few products may take even longer.

At the fee level: Article 3.4 cites Executive Decree No. 32780 of 2005, which sets the rates for the processing, registration and inspection/supervision of EMB. The RTCR does not set amounts itself, but every registration, renewal and change must include proof of payment (Articles 11.10, 16.11 and the relevant paragraphs of Article 18). The specific amounts follow the Ministry of Health’s current fee schedule; fixed US dollar figures circulating online should not be cited.

At the project level (experience-based judgment, not a legal commitment): the main variable determining the cycle is the completeness of the dossier at first submission. The three high-frequency deficiency points are the CLV authentication chain, the powers in the power of attorney and the label elements; for Classes 3 and 4, insufficient clinical evidence adds deficiency-response rounds that significantly lengthen the overall cycle.

Legal basis: Article 14, Article 3.4, Article 5 and Article 11.10; Article 34.2.4.1 of 37988-S (as amended).

Q17. With an FDA or CE certificate, is there a simplified pathway?

Answer: Yes, but the logic is not “a certificate means simplification”; it is “country-to-country mutual recognition”.

Article 17.1: under Article 6.1 of the WTO Agreement on Technical Barriers to Trade, the Ministry of Health may accept conformity assessment results from government bodies of countries that have completed mutual recognition under the procedure in Annex B. Article 17.2: such applications only need 8 items – application form, technical and medical specifications, CLV, radiation source authorization, label, proof of payment, contract manufacturing agreement and power of attorney; clinical evidence and the like may be waived. Article 17.3: the Ministry of Health reserves the right to require the waived documents during or after the registration process.

The mutual recognition procedure of Annex B (which most articles omit, but it is critical): the exporting country’s government makes a formal request to the Minister of Health -> the Ministry establishes contact within 10 days -> information on regulations, bilateral trade volume, regulatory authorities and inspection systems is submitted -> comparison and verification -> a decision within 3 months from completion of the verification -> the decision is published in the Official Gazette and notified to the WTO; where regulations change or a safety alert arises, the Ministry may withdraw the mutual recognition.

The 2024 amendment tightened this: where the CLV submitted comes from a country with no mutual recognition relationship, a registration originally obtained through the mutual recognition pathway may no longer rely on that pathway, and the full dossier under Articles 11, 12 and 13 must be completed (amended Articles 4.7, 17.3 and 18.11.4). In other words, the reference-country qualification and the CLV issuing country must match.

Legal basis: Article 17 and Annex B; 2024 amendment.

6. After the certificate: validity, changes and post-market

Q18. How long is the registration valid, and how is it renewed?

Answer: Article 15: validity of 5 years. Article 16: the renewal term is the same as the original registration and must be submitted through Registrelo before expiry: renewal application form, power of attorney (if missing or expired), contract manufacturing agreement (if missing or expired), sworn statement that the product has not changed, BPM certificate, domestic premises permit or imported-product CLV, label (if not on file), updated radiation source authorization, animal tissue biosafety certificate, and proof of payment.

The regulation sets no fixed advance window (for example, “6 months in advance” is not a statutory requirement); it only requires “before expiry”. If it is not renewed before expiry it lapses and must be registered again.

Practical advice (experience value): start at least 6 to 9 months in advance, and bundle the renewal with label versions, the distributor list and CLV updates to avoid a state where “the renewal is approved but changes are still pending”.

In addition: Registrelo is open to the public; anyone can query a product’s registration status and processing progress, making it the official entry point for due diligence and competitor research.

Legal basis: Articles 15 and 16; the public query instructions of the Registrelo portal.

Q19. After the certificate is granted, which changes are “notifications” and which need “approval”?

Answer: The principle is that changes must be approved before implementation, with notification types as the only exception (introduction of Article 18). There are only four notification types: label design changes, cancellation of codes, change or addition of local distributors, and a change of the holder’s address without changing the country of origin; the review period is 5 business days.

All others are approval types, mainly: change of holder or manufacturer name, change of holder (transfer), change of legal representative, change of product name, change of manufacturer, change of manufacturing site (including relocation across borders), change of specifications/models/description, change of instructions for use, change of intended use or medical specifications, version changes, and changes to family/system composition. Most require the CLV, BPM certificate, label, power of attorney and proof of payment; cross-border relocation to a country without mutual recognition requires the full dossier (Article 18.11.4).

One commercial conclusion: replacing a distributor does not require re-registration, only a change – this is exactly the institutional basis for separating the registration certificate from distribution rights.

Legal basis: the paragraphs of Article 18 and Article 5.

Q20. What ongoing obligations exist after market entry, and what are the consequences of violations?

Answer: Three lines run in parallel:

• Advertising: Article 20 requires EMB advertising to comply with the current Regulation on the Licensing and Control of Advertising of Health-Related Products (Executive Decree No. 36868-S of 2011); advertising unregistered products or making claims beyond the registered intended use are violations.
• Technovigilance: Article 21 requires all responsible parties for EMB to comply with Executive Decree No. 39342-S of 2015 (National Technovigilance System Regulation) and to fulfill adverse event and corrective action reporting obligations.
• Inspection and penalties: Article 22 provides that the Ministry of Health may verify registration conditions at any time; Article 2 of the decree classifies violations as minor, serious or extremely serious (selling without registration, advertising beyond the registered intended use, distributing in unauthorized premises, tampering or selling expired products, and so on); Article 3 provides that health measures may be taken under the General Health Law, recalls ordered, and registrations suspended or cancelled, with immediate cancellation in extremely serious cases.

Legal basis: Articles 20, 21 and 22 and Articles 2 and 3 of the decree; 36868-S; 39342-S.

Three popular claims that must be corrected

“Class 1 is registration-exempt, so nothing needs to be done” – wrong. Only registration is waived; the four obligations of labeling, import, advertising and vigilance all remain in full (Article 2.4).

“With FDA or CE you can sell directly and get automatic simplification” – wrong. Simplification depends on whether the country has completed Annex B mutual recognition with Costa Rica, and the CLV issuing country must match that mutual recognition relationship (Article 17).

“The registration certificate must be held in the distributor’s name” – inaccurate. The holder can be the foreign manufacturer; only a local legal representative and a licensed importer are needed, and distributors are listed as “authorized distributors” and can be replaced under Article 18.8 (Articles 4.56, 4.60, 10.11 and 18.8).

Index of the original regulatory texts

• Decreto Ejecutivo No. 43902-S (2022-11-30), approving RTCR 505:2022 “Equipo y Material Biomedico. Clasificacion, Registro, Importacion, Etiquetado, Publicidad, Vigilancia y Control”. Final text of the measure submitted by Costa Rica to the WTO/TBT Committee (Spanish, 56 pages): https://members.wto.org/crnattachments/2022/TBT/CRI/22_3088_00_s.pdf
• 2024 amendment (document number MS-AJ-CB-200-2024; WTO notification G/TBT/N/CRI/71/Add.4), amending Articles 4.7, 10.20, 17.3 and 18.11.4 and transitional provision III: https://members.wto.org/crnattachments/2024/TBT/CRI/final_measure/24_00776_01_s.pdf
• Decreto Ejecutivo No. 37988-S (2013-10-03), Regulation on the Operation and Use of the Registrelo portal; Article 34.2.4.1 was amended by Article 5 of Decree No. 43902-S.
• Decreto Ejecutivo No. 39342-S (2015), National Technovigilance System Regulation.
• Decreto Ejecutivo No. 32780 (2005-10-25), rates for the processing, registration and inspection/supervision of EMB.
• Decreto Ejecutivo No. 36868-S (2011), Regulation on the Licensing and Control of Advertising of Health-Related Products.
• Decreto Ejecutivo No. 24037-S (1994), Regulation on Protection Against Ionizing Radiation.
• Ley No. 5395 (1973), General Health Law.
• Registrelo official portal: https://registrelo.go.cr

Note: items 1 and 2 above are the official texts submitted by the Government of Costa Rica to the WTO and match the versions published in the Official Gazette in article numbering; the article numbers cited in this article follow those texts. For individual cases, defer to the Ministry of Health’s latest announcements and review opinions.

This article is compiled from publicly available texts of Costa Rica’s current regulations for industry exchange and reference; it does not constitute legal advice or any commitment as to review outcomes. Regulations and fees are subject to the Ministry of Health’s latest publications.