Bolivia Medical Device Registration: 20 FAQs on AGEMED Registration and Compliance (2026)

Chinese-language “guides” on Bolivia medical device registration are highly repetitive: Class I to III, certificates valid for five years, and a local agent is mandatory. The direction is not wrong, but almost nobody tells you that the technical basis for device registration in Bolivia is still a manual approved on January 17, 2006; and nobody warns you that this manual contains a clause stating “the registration certificate does not necessarily belong to the company that processed it”, which directly determines your leverage when negotiating with local distributors.

A more common error is the decree number. Many articles treat RM 0909/2005 as the device registration basis – that is the drug registration manual; the device registration manual is RM 0010 (January 17, 2006). This detail is stated clearly in AGEMED’s own Administrative Resolution No. 04 of 2024.

All content in this article is drawn exclusively from primary sources: the regulations, administrative resolutions and communiques currently published on the AGEMED official website (agemed.gob.bo), and the official status table of the Hague Conference on Private International Law (HCCH). Verification date: October 26, 2026. Every conclusion is annotated with a clause number that can be traced directly back to the source text.

Six numbers to remember first:

• 5 years: validity of the registration certificate
• 30 working days: target timeline for certificate issuance after acceptance, as set in the manual
• 60 calendar days: response window for observations (Observado)
• 30 calendar days: grace period during which a renewal may still be filed after expiry (the manual is internally inconsistent on this; see Q17)
• 15 working days: notification deadline for most amendments and events
• 5 working days: advance notice required for price reporting (Administrative Resolution No. 20 of 2023)

Part 1 The Regulatory Framework: First Understand Who Regulates and Under What Rules

Q1 Which agency regulates medical devices in Bolivia, and what is the legal basis?

Bottom line: The regulator is the National Agency for Medicines and Health Technologies (AGEMED), under the Ministry of Health and Sports (Ministerio de Salud y Deportes). The hierarchy of norms governing device registration has four layers: law – Supreme Decree – Ministerial Resolution – technical manual.

Official basis:

• DS 2905 (September 21, 2016): establishes AGEMED on the basis of UNIMED and CONCAMYT as a decentralized public agency under the Ministry of Health and Sports, with managerial, administrative, financial, legal and technical independence; Article 7 lists its functions covering the full medicines-and-devices chain of “evaluation, authorization, regulation, oversight and control”.
• Ley 1737 (December 17, 1996), the Law on Medicines: the legal origin of the registration system.
• DS 25235 (November 30, 1998): the implementing regulation of Ley 1737; Article 5 provides the definition of “medical device” and Article 149 sets out packaging labeling obligations.
• DS 26873 (December 21, 2002): the National Unified Supply System.
• RM 0010 (January 17, 2006): approves the Manual for the Sanitary Registration of Medical Devices (Manual para Registro Sanitario de Dispositivos Medicos) – this is the operational basis for device registration.
• RM 0298 (June 11, 2002): approves the Manual for the Sanitary Registration of Diagnostic Reagents; IVDs follow this track.

Practical tip: Unlike drugs, the AGEMED website does not publish a separate collection of “registration guides” by device category; the details of device filing are all in that manual. In due diligence, first ask the counterparty to point to the specific clause it relies on, rather than merely citing a decree number.

Q2 Why does a manual from 2006 still apply today? What changed in 2026?

Bottom line: The manual has not been repealed and remains the currently published technical basis for device registration on the AGEMED website under its “Drug Regulations – National Norms” section; but several newer administrative resolutions and platform rules have been layered on top of it, creating a pattern of “old manual + new procedures”.

Official basis and list of changes:

• As of October 26, 2026, the AGEMED website still lists that manual as the current text for device registration; its legal continuity is expressly confirmed in RA 04/2024 (March 14, 2024), which cites the “Manual for the Sanitary Registration of Medical Devices approved by RM 0010 (January 17, 2006)”.
• RA 020/2023 (October 18, 2023): establishes the technical-administrative reporting system for drugs, vaccines, medical devices, diagnostic reagents and medical equipment, and clarifies that price reporting must be completed through the “AGEMED VIRTUAL” platform.
• RA 04/2024: approves the National List of Medical Devices and Others, LINADIME 2024-2026, but Article 4 expressly states that it is a reference document only and not mandatory (see Q3 for details).
• October 2026 platform migration: via communique MSyD/AGEMED/CR/32/2026 (October 2, 2026), AGEMED activated Phase One of the “AGEMED Virtual – MISA” platform, covering billing, process integration and subsequent notifications; in the same period, CR/34/2026 (October 15, 2026) launched the 2027 annual corporate re-registration.
• Draft IVD manual: the website’s “Normas en Consulta” (rules under consultation) section posts a draft 2025 manual for the registration of in vitro diagnostic reagents. Until it is formally approved, IVDs remain subject to RM 0298/2002.

Practical tip: This means two things. First, requirements from the paper/counter era may not map one-to-one onto the online platform’s form fields, so check the current communiques before filing. Second, any claim that “Bolivia just issued new device regulations and everything must be redone” should be challenged to produce AGEMED’s resolution number.

To clarify a common confusion along the way: the application form in the manual itself is still written as “DINAMED Form 027”, because the regulator was named DINAMED when the manual was drafted. The agency went through several reorganizations; its functions passed to UNIMED and were merged into AGEMED in 2016, but the form number and clause numbering remain in use today – which is why you will see all three names, DINAMED, UNIMED and AGEMED, in different documents.

Q3 Do all medical devices have to be registered? Is there a difference between IVDs and equipment?

Bottom line: Any product falling within the device definition in Article 5 of DS 25235 that is manufactured, imported, distributed, commercialized or used in Bolivia must obtain sanitary registration; there is no exemption or “registration-free filing” track based on risk class. But IVDs and medical equipment each carry additional requirements.

Official basis (manual clauses):

• Section 1.4 Scope: applies to all medical devices manufactured, imported, distributed, commercialized and used in the country.
• Section 1.5 Registrable business activities: manufacture and sale; import and sale; import followed by packaging and sale; import followed by processing of semi-finished products and sale; import followed by assembly and sale; manufacture and export; import followed by adaptation and sale – seven categories in total, all requiring registration.
• IVDs: subject to the Manual for the Registration of Diagnostic Reagents under RM 0298/2002, with application on Form 012 (as distinct from Form 027 for devices).
• Medical equipment (equipo biomedico): in addition to registration, a declaration from the manufacturer or the Bolivian representative must be submitted under Section 2.9 (non-experimental, able to supply parts and repair service within five years, provides operational training, provides manuals in the original language and in Spanish), and annual reporting of import/manufacture/sales quantities, serial numbers and installation locations under Section 2.9.1.

Practical tip: LINADIME 2024-2026 (24 major categories, 1,927 devices and related equipment) is often misread as a “registration catalog”. Article 4 of RA 04/2024 makes clear that it is a reference document only, not mandatory; do not treat it as a filing pathway or an exemption basis.

Q4 How is the risk classification determined, and under what rules?

Bottom line: Four classes – I / IIa / IIb / III – applying the 16 classification rules of the GHTF (Global Harmonization Task Force); the manufacturer self-classifies, and AGEMED retains the right to review and reclassify.

Official basis (manual clauses):

• Section 1.7: classification is determined jointly by “duration of contact, degree of invasiveness, local effects and systemic effects”; the definitions and typical examples of the four classes are as follows – Class I (low risk, e.g. simple surgical instruments, tongue depressors), Class IIa (low-to-medium risk, e.g. hypodermic needles, suction equipment), Class IIb (medium-to-high risk, e.g. ventilators, orthopedic implants), Class III (high risk, e.g. heart valves, implantable defibrillators).
• Section 1.7.1(d): where several rules apply to the same device, the highest class governs.
• Section 1.7.2: incorporates the 16 GHTF rules one by one (the first eight non-invasive rules, invasive devices, active devices, plus additional rules for drug-containing devices, devices with human/animal tissue, disinfection, contraception, etc.). Combination devices containing a drug as an ancillary action fall directly into Class III; long-term implantable devices are in principle Class IIb, and rise to Class III if they contact the heart, the central circulatory or central nervous system, or are life-sustaining, or are absorbable.
• Section 2.4.7: where the Free Sale Certificate does not state the class, the manufacturer declares the class it has determined.
• Section 1.7 note: AGEMED may reclassify based on post-market experience or product improvements.

Special caution: Annex 2 of the manual, “Device Grouping”, lists 29 groups by product family (10 non-invasive, 15 invasive, 4 active) with an annotated reference level for each group, but the annotations for a few individual groups are inconsistent with the 16 rules (for example, implantable cardiac pacemakers are listed under a Group IIa entry, whereas under Rule 8 they should be at least Class IIb). In such cases, classify first under the rules, then confirm “group assignment plus class” with AGEMED in writing; do not simply copy the Annex annotation.

Part 2 Who Holds the Certificate: The Most Critical Part of This Article

Q5 Can a foreign manufacturer apply for the registration certificate by itself?

Bottom line: No. The applicant must be a legally established company in Bolivia holding a health-activity license, staffed with a certified technical responsible person (regente / responsable tecnico).

Official basis (manual clauses):

• Section 2.2.1: must submit a copy of the Ministerial Resolution or Secretariat Resolution approving the company’s business operations.
• Section 2.2.2: must submit a currently valid Company Certificate (Certificado de Empresa) issued by AGEMED, evidencing that the operating license, annual re-registration and annual inspection have all been fulfilled.
• Section 2.1: Form 027 must be signed and stamped jointly by the company’s legal representative and the technical responsible person, as a declaration of the truthfulness of all dossier contents. The professions eligible to serve as technical responsible person are: pharmacist, pharmaceutical chemist, physician, biomedical engineer, industrial engineer, electronics engineer, mechanical engineer and chemical engineer.
• Section 2.3.4: the manufacturer’s authorization of the local company (representacion legal) is not part of each dossier, but it must be filed in advance in original form with the AGEMED Surveillance and Control Division, and requires no consular legalization.

Practical tip: Section 2.3.4 is an easily overlooked “prerequisite step” – if the authorization document has not been pre-filed, no matter how polished the dossier, it will not enter substantive review.

Q6 Who actually owns the registration certificate? This clause determines your negotiating position

Bottom line: The manual expressly states that the registration certificate does not necessarily belong to the company that processed the registration, but to the party holding the product license or to the manufacturer of the product.

Official basis (manual Section 3.2.1): “It must be taken into account that the sanitary registration certificate does not necessarily belong to the company that carried out the registration procedure; on the contrary, it belongs to the party holding the product license or acting as the manufacturer of that product.”

Why this clause matters:

• The certificate holder on its face is the Bolivian importer; but ownership at the clause level points to the product licensor/manufacturer. This gives you a textual basis for asserting that “the certificate should follow the manufacturer”, rather than relying purely on commercial negotiation.
• The manual contains no standalone “transfer of holder” procedure; it only lists “change of manufacturer or holder name” as a correctable item (Section 5.10.1). This means that switching local companies usually requires a choice between “correction” and “cancellation followed by a new filing” – a large difference in cost and time.
• When the holder voluntarily ceases commercialization, it must notify AGEMED within 20 working days to process the cancellation (Section 3.1.6); AGEMED may also cancel upon application by an interested party (Section 5.11(a)).

Practical tip (four clauses you can write directly into a distribution agreement):

• The registration certificate and all derivative rights belong to the manufacturer; the distributor appears solely as the “filing and import entity”;
• When the manufacturer so requests, the distributor must cooperate within the agreed period to process a change or cancellation of the certificate holder, at the manufacturer’s expense;
• Ownership of all dossier materials, correspondence and review comments belongs to the manufacturer, and the distributor may not withhold them;
• After termination of the agreement, the distributor may not use the registration certificate as leverage to demand compensation or block the transfer.

Q7 When selecting a local importer, what should you verify?

Bottom line: A business license alone is not enough; you must verify “two certificates and one inspection”: the Ministerial Resolution authorization, a current Company Certificate, and annual inspection records; and confirm that the company has completed the current year’s annual corporate re-registration.

Official basis:

• Sections 2.2.1 and 2.2.2: Ministerial Resolution plus current Company Certificate (missing either constitutes grounds for rejection; see Section 3.1.4(c)).
• Section 5.7.2: all companies must complete re-registration for the following year by December 31 each year.
• 2026 practice: AGEMED communique MSyD/AGEMED/CR/34/2026 (October 15, 2026) has launched the 2027 annual corporate re-registration – if you sign a contract in Q4 2026, make sure the counterparty has completed the 2027 re-registration, otherwise you will be blocked on entity-qualification grounds in Q1 of next year.

Part 3 The Dossier: Check Item by Item, Not from Experience

Q8 What are the hard requirements for the quality system certificate?

Bottom line: A GMP or equivalent quality system certificate is required, covering every site involved in production (including packaging sites), issued within the last two years, and certified by the health authority (consular legalization is not mandatory).

Official basis (manual Section 2.3.1): submit the quality system (GMP or equivalent) certificate in original, or a copy certified by the health authority; consular legalization is not required; it must cover all plants involved in manufacture, including adaptation or packaging plants; the certificate must not be more than two years old. AGEMED reserves the right to request on-site inspections at any time, or to request compliance information from the regulator of the country of origin.

Practical tip: An ISO 13485 certificate is not the same as a GMP certificate. The manual requires “quality system certification (GMP or equivalent)”; at review, what matters is whether it covers the declared product lines and actual production sites, and whether the remaining validity can cover the entire review cycle. Slotting an soon-to-expire ISO certificate into the dossier is the most common self-check omission.

Q9 How is the Free Sale Certificate (FSC) issued? Can an Apostille be used?

Bottom line: The FSC must be issued or endorsed by the health authority of the country of origin and legalized by a Bolivian consulate; in countries without a Bolivian consulate, certification by the Bolivian Ministry of Foreign Affairs plus the original document applies. Where the certificate does not state a validity period, two years from the date of issuance apply. The Hague Apostille is legally feasible, but the manual text has not been revised, so written confirmation from AGEMED must be sought case by case.

Official basis:

• Section 2.3.2: submit a device certificate evidencing that the product is authorized in the country of origin, endorsed by the health authority of the country of origin and legalized by a Bolivian consulate; exceptions: (a) where no validity period is stated, the validity stated on the registration certificate or two years from the date of issuance; (b) where the country of origin has no Bolivian consulate, certification by the Bolivian Ministry of Foreign Affairs plus originals from the competent authority of the country of origin.
• Apostille Convention: according to the HCCH official status table, Bolivia acceded on September 6, 2017, and the Convention entered into force for it on May 7, 2018, with no objection raised. The manual (2006) naturally does not cover this scenario.

Practical tip:

• The prudent path: obtain the Apostille first (faster and cheaper) while simultaneously submitting a written inquiry to AGEMED confirming whether it is accepted; if the reply is ambiguous, proceed with consular legalization, so as not to gamble the timeline on a single path.
• Note for Chinese manufacturers: China has applied the Convention since November 7, 2023; Chinese public documents with an Apostille are valid among contracting states, but whether AGEMED accepts them is an administrative discretion, not an automatic effect.
• If the product is manufactured solely for export and not marketed in the country of origin, a conventional FSC cannot be obtained, and the filing of an OEM-type company will stall at this point. Do not assume that an “export sales certificate” can substitute; agree on an alternative with AGEMED in advance.

Q10 What exactly does the technical documentation include?

Bottom line: Manual Section 2.4 lists 11 items in total; a missing item constitutes grounds for observation or rejection. The two most frequently omitted items are “international codes” and “the lot number coding rule”.

Official list (manual Sections 2.4.1 – 2.4.11):

• Description of parts and components: list of main components, composition, specifications, working principle and descriptive information;
• Certificate of analysis or design verification/validation report: certificate of analysis of the finished product, or test reports of design verification and validation, including specifications, acceptance values and ranges, signed and stamped;
• Shelf life: expressed in months, required according to risk class;
• Storage conditions: storage and preservation conditions;
• International codes: ECRI, GMDN or other internationally recognized codes (frequently omitted);
• Lot number coding rule: the lot numbering rule used for the finished product and its interpretation, on a separate annexed page (frequently omitted);
• Risk classification: declared by the manufacturer where the FSC does not state it;
• Efficacy and safety: see Q11;
• Summary of usage information: indications, intended use, warnings, precautions, contraindications;
• Sterilization method: state where applicable;
• Final disposal: state the destruction or disposal method where applicable.

Q11 When must clinical data be submitted?

Bottom line: Medium-to-high risk (IIb) and high risk (III) devices, particularly new products, must submit clinical study data supporting safety and efficacy; other classes only need to submit a summary of usage information.

Official basis (manual Section 2.4.8): “For products classified as medium-to-high risk and high risk, as applicable and in particular for new products, studies on use shall be submitted to demonstrate the safety and efficacy of the product.”

Practical tip: The clause uses “as applicable (segun corresponda)”, a discretionary formulation. For Class IIb/III, prepare a combination of “clinical evaluation report + literature review + clinical evidence from the country of origin”, rather than merely handing over a summary of a CE/FDA review conclusion – the latter cannot replace the chain of evidence “demonstrating safety and efficacy” required by the manual.

Q12 What must be done for labels, instructions for use and packaging markings?

Bottom line: Labels may be multilingual but must include Spanish; packaging must additionally bear a sticker/mark identifying the Bolivian selling company (Article 149 of DS 25235), and its design artwork must be submitted with the dossier.

Official basis:

• Section 2.5.1(b): multilingual labels are accepted, provided one of the languages is Spanish.
• Section 2.5.1(c): the label must at least contain the product name, lot number or serial number, expiry date where applicable, manufacturer’s name, and special warnings.
• Section 2.5.1(d): pursuant to Article 149 of DS 25235, whether imported or domestically produced, every sales package must include a sticker, stamp, label or printed mark identifying the company selling the product, and its design or format must be included in the dossier.
• Section 2.7: operating, maintenance and installation manuals must be in Spanish, and their content must cover contraindications, warnings, installation verification, the nature and frequency of preventive maintenance, calibration, sterilization, environmental interference (magnetic fields, external electric fields, static electricity) and disposal, among others.

Practical tip: “Label-to-product consistency” is a high-frequency observation area. Common problems: the label artwork in the dossier is the English master, the physical product already carries a Spanish sticker, but the sticker design is not in the dossier; or the selling company stated on the packaging is not the same entity as the registered certificate holder.

Q13 Are samples required? What additional steps apply to equipment?

Bottom line: Samples are mandatory only for low risk (Class I); other classes need not submit samples, but AGEMED may inspect physical products at company warehouses at any time. Equipment additionally requires a specific declaration and annual reporting of installed units.

Official basis:

• Section 2.6: submitting samples with the dossier is a mandatory condition for low-risk devices to obtain the certificate; low-to-medium, medium-to-high and high-risk devices are not required to submit samples, but the authority may inspect products at company or institution warehouses at any time.
• Section 2.9: equipment must be accompanied by a declaration issued by the manufacturer or the Bolivian representative stating that: the equipment is not in an experimental stage; there is the capacity to supply consumables, parts, spare parts and repair service within five years (or within the equipment’s life if shorter); a mechanism exists to train users in operation and repair; and operating, installation and maintenance manuals, plus statements of indications and intended use, are provided in the original language and in Spanish.
• Section 2.9.1: the certificate holder must report annually the quantities imported, manufactured and sold, the serial number of each unit, and its geographic and institutional location.

Part 4 Process, Timelines and Fees: Separate the Official Clock from the Project Clock

Q14 What is the standard process, and what outcomes can occur?

Bottom line: Pay the fee -> obtain the payment slip -> submit the dossier -> evaluation -> three possible outcomes (approved / observed / rejected) -> certificate issuance. After approval, imported devices receive a DI number and domestically produced devices a DN number.

Official basis (manual Section 3.1):

• Section 3.1.1 Payment: pay the registration evaluation fee into account 3G-300 of the Ministry of Health and Sports at the Central Bank of Bolivia;
• Section 3.1.2 Payment slip: present the payment receipt at the counter to obtain the payment slip, one per group;
• Section 3.1.3 Dossier submission: submit the full set of materials and the green copy of the payment slip at the records window;
• Section 3.1.4 Evaluation:

• Approved (Aprobado): all requirements met; the Registration and Evaluation Division prepares and signs the registration certificate, countersigned by the Deputy Directorate of Drugs and Technologies, with codes DN (domestic) / DI (imported);
• Observed (Observado): technical issues that can be corrected exist; a notice stating the issues is issued, and the applicant must respond within 60 calendar days and return it together with the notice; only in exceptional cases and upon written request may the dossier be returned to the applicant;
• Rejected (Rechazado): for absence of the application form, the Ministerial Resolution copy, the Company Certificate, the prior certificate copy required for renewal, the control certificate, the parts description, the label, the instructions for use and, where applicable, samples, the dossier is rejected under Chapter IV of DS 25235; the dossier is returned to the applicant and may re-enter evaluation within no more than 60 calendar days after submitting proof of payment for a “second evaluation”.

Practical tip: Note the difference in nature between “observation” and “rejection” – missing “hard documents” leads directly to rejection (requiring payment again); only “technical issues that can be corrected” are given an observation window. This determines whether you should “file first and think later” on your first submission: in Bolivia, filing prematurely may cost you a complete refiling.

Q15 Is the 30-working-day certificate issuance real?

Bottom line: 30 working days is the certificate issuance timeline set in the manual (counted from the date the dossier enters the Directorate); it is not the project timeline. Including notarization/legalization, Spanish translation and observation back-and-forth, the actual timeline is significantly longer.

Official basis (manual Section 3.1.5): “Within 30 working days from the date the dossier enters the Deputy Directorate of Drugs and Technologies, the original of the sanitary registration certificate shall be delivered, valid for 5 years, and the holder is entitled to two certified copies free of charge.”

Practical tip: Break the project plan into four segments – (1) legalization and translation (incompressible; depends on notary/consulate/Apostille scheduling); (2) dossier preparation and internal quality control; (3) official review (the statutory 30-working-day target plus the 60-calendar-day observation window); (4) certificate issuance and collection. Any plan quoting only the “official 30 working days” hides the real workload of the first three segments.

Q16 What is the structure of official fees? Which steps trigger a second charge?

Bottom line: Official fees are charged item by item under AGEMED’s Schedule of Service Fees (the current version on the website is labeled the “new fee schedule” of May 29, 2018), paid into the Ministry of Health and Sports account at the Central Bank; each registration group gets a separate payment slip; in addition, at least three steps may trigger a second fee.

Official basis:

• Section 3.1.2: one payment slip “per group” – meaning fees are tied directly to the number of groups, not to the number of product models.
• Section 3.1.4(c): a rejected dossier that is re-evaluated requires payment of a second evaluation fee.
• Section 3.1.7: a renewal application submitted within 30 calendar days after the certificate expires must pay fees at the standard for first registration.
• Sections 2.10 / 5.10: corrections (rectificacion) require payment of the corresponding service fee.

Practical tip: At the quoting stage, first do a “group count estimate” – map the product catalog to the 29 groups under Annex 2 of the manual; items in the same group and class can be combined (Section 5.10.2), while items across groups must be certified separately. Getting this step wrong makes fees deviate from budget by multiples. For specific amounts, follow AGEMED’s current fee schedule, and require the service provider to state in the contract that “official fees are reimbursed at actual cost”.

Part 5 After the Certificate: The Real Cost of Compliance Lives Here

Q17 How long is the certificate valid, and what should you watch in renewal?

Bottom line: Validity is 5 years. Renewal should be filed within the 3 months before expiry; there is a short grace period after expiry, but the manual itself is inconsistent in stating “calendar days vs working days” – do not rely on that grace period.

Official basis:

• Section 3.1.5: validity of 5 years.
• Section 3.1.7: renewal should, as far as possible, be submitted within the 3 months before the certificate expires; applications submitted within 30 calendar days after expiry pay fees at the standard for first registration.
• Section 2.3.3(a): applications submitted before the 5 years elapse and, as a grace, no later than 30 working days after expiry, may be treated as renewals in progress, and the certificate remains valid for manufacture, import, distribution and sale.

Please note: The same manual writes “30 working days” in Section 2.3.3(a) and “30 calendar days” in Section 3.1.7. This is not a typo that can be ignored – the two differ by roughly three weeks. For internal control, operate on “start 3 months before expiry” and treat the grace period as zero.

Q18 New models, label changes, plant changes: amendment or re-registration?

Bottom line: Changes that do not constitute a substantive change go through “correction (rectificacion)”, retaining the original number and validity; changes that do constitute a substantive change require re-registration. New models may be added to an existing certificate only when they are in the same risk class and the same group.

Official basis:

• Section 5.10: situations acceptable as corrections include minor changes in composition, packaging, label, design, energy source, manufacturing process, shelf life, and change of manufacturer or holder name, among others; a new Form 027, the original certificate, proof of payment and the corresponding supporting materials must be submitted.
• Section 5.10.1: a change of manufacturer or licensor name is not a mandatory correction; it is processed only at the company’s request and must be supported by documentary evidence.
• Section 5.10.2: adding items to a certified product is handled as a correction, provided those items belong to the same risk class and the same group.
• Section 2.10: the corrected certificate retains the original code, number and validity.
• Section 5.11(b): a substantive change to approved parts and components not disclosed to the authority constitutes a statutory ground for cancellation of the registration certificate.

Practical tip: Make “change assessment” a routine process rather than an ad hoc judgment. The highest-risk scenario is a factory relocation or a new packaging line – this triggers both a correction (change of manufacturing site) and an update of the quality system certificate’s coverage (Section 2.3.1); the two must be done in sync.

Q19 After obtaining the certificate, what ongoing obligations remain?

Bottom line: At least six: printing the registration number on packaging, notification before first sale, price reporting, annual corporate re-registration, notification of change of technical responsible person, and annual reporting of installed equipment. Missing any one is a punishable compliance gap.

Official basis:

• Section 5.7.1 Registration number on packaging: sales packages must display the registration number in a prominent place by printing, stamping with indelible ink, or a sticker; the year may be abbreviated to two digits.
• Section 5.9.1 Notice before first sale: before each product begins commercialization, a “notice of commencement of commercialization” must be submitted.
• Section 5.9.2 Price reporting: the reference sales price must be reported 5 days before first sale or any price change; this obligation has been tightened by Article 1(a) of RA 020/2023 to 5 working days, submitted through the AGEMED VIRTUAL platform (that resolution expressly applies to medical devices).
• Section 5.7.2 Annual corporate re-registration: re-registration for the following year must be completed by December 31 each year (communique CR/34/2026 of October 15, 2026 has launched the 2027 cycle).
• Section 5.9.3 Change of technical responsible person: notify within 15 days and submit the new professional’s details with payment of the fee.
• Section 2.9.1 Annual equipment report: equipment certificate holders report annually the quantities imported/manufactured/sold, serial numbers and installation locations.

Also note: Section 5.9.4 cessation of business (partial or total, temporary or permanent) requires 5 days’ advance notice; Section 5.9.5 change of address must be declared on Form 003 within 5 days of the change; and the general rule in Section 5.9 requires all mandatory notifications to be completed within 15 working days. One easily confused point: the monthly inventory reporting obligation under RA 020/2023 applies only to drugs listed in LINAMIE, not to devices – on the device side, only the price reporting applies.

Q20 What happens when something goes wrong? What are the most common rejection reasons?

Bottom line: Three consequences – observation, rejection, and cancellation (which triggers a deadline for market withdrawal). High-frequency rejection causes cluster around “missing hard documents”, not insufficient technical depth.

Official basis:

• Section 3.1.4(c) list of rejection grounds: missing application form (Form 027), missing Ministerial Resolution copy, missing Company Certificate, missing prior certificate copy for renewal, missing control certificate, missing parts description, missing label/instructions for use, and, where applicable, missing samples.
• Section 5.4 Appeal: a party disputing a rejection may appeal to the Quality Assurance Committee (Comite de Garantia de Calidad), submitting a technical report of reasons signed by the technical responsible person and the legal representative.
• Section 5.11 Cancellation grounds: (a) application by an interested party, following evaluation; (b) substantive changes to approved parts and components not disclosed; (c) cancellation by resolution of the authority following review of a vigilance report.
• Section 5.11.1 Market withdrawal deadlines: depending on the severity of the health risk, withdrawal deadlines of 72 hours / 3 months / 9 months are set respectively, with the company bearing responsibility for the withdrawal.
• Vigilance system: post-market surveillance of devices relies on the National Drug Surveillance and Control System established by RM 0250 (May 14, 2003); manual Section 5.11 cites that system directly and applies its rules to device cancellation and withdrawal. As of October 26, 2026, no separately published “device vigilance manual” was found on the AGEMED website (the existing specialized chapters are pharmacovigilance, GMP and GCP); the reporting pathway for related adverse events should be confirmed in writing with the AGEMED Surveillance and Control Division at project initiation, and information-transfer timelines between manufacturer and certificate holder should be agreed in the quality agreement.

Field advice (three things that minimize rejection rates):

• Run a “hard document checklist”: Form 027, Ministerial Resolution, Company Certificate, prior certificate copy (renewal), control certificate, parts description, label and instructions for use, samples (Class I) – sign off item by item; if one item is missing, do not file.
• Keep labels “consistent across three versions”: the master label, the Spanish sticker artwork and photos of the physical product must all match, and all must appear in the dossier.
• Pre-file the authorization: under Section 2.3.4, complete the filing of the manufacturer’s authorization in original with the Surveillance and Control Division before submitting the dossier.

Annex: Regulation index (verify directly on the AGEMED website)

This article is compiled from the original texts of regulations, administrative resolutions and communiques published on the AGEMED website as of October 26, 2026, with the Hague Apostille information verified against the HCCH official status table. Regulations and platform procedures may be updated; specific projects should follow the latest AGEMED texts, current communiques and written case-by-case replies. This article does not constitute legal advice.