Cambodia medical device registration resources

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ASEAN Medical Device Directive in force for Cambodia from 27 March 2019

Cambodia deposited an Instrument of Acceptance of the ASEAN Agreement on Medical Device Directive on 27 March 2019, as recorded by the ASEAN Secretariat's Treaty Division; because AMDD Art.…

ASEAN Medical Device Directive — Cambodian signature

Cambodia is a signatory of the ASEAN Agreement on Medical Device Directive (AMDD), signed at Bangkok on 21 November 2014; the instrument was signed for Cambodia by Sun Chanthol, Senior Mini…

Products expressly outside the device regime

Human blood, plasma or blood cells of human origin and devices incorporating them, transplants or tissues or cells of human origin and products incorporating or derived from them, and trans…

Definition of a medical device and of an accessory, and treatment of accessories as devices

The instrument binding Cambodia defines a 'medical device' as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other…

AMDD classes A, B, C and D applied by the Department of Drugs and Food

Class A, Class B, Class C, Class D

National registration with the Cambodian regulatory authority required before market placement

A medical device intended for the Cambodian market must be registered with Cambodia's own regulatory authority; the ASEAN Medical Device Directive under which Cambodia's controls are aligne…

ASEAN Common Submission Dossier Template — harmonised dossier format only

statement: Cambodia's device submission follows the ASEAN Common Submission Dossier Template (CSDT): the AMDD, which Cambodia has accepted, requires Member States to undertake appropriate m…

The person responsible for placing devices on the market must be licensed

The person responsible for placing medical devices on the Cambodian market must be licensed by Cambodia's regulatory authority before the devices are placed on the market, and each Member S…

All medical equipment, including imports, requires MOH visa registration; applications must attach GMP or ISO

Cambodia’s National Trade Repository records Prakas No. 1258 as requiring Ministry of Health visa registration for all medical equipment, including imports, and attachment of GMP or ISO cer…

Technical documentation follows the ASEAN CSDT

Technical documentation for a device submitted under the ASEAN framework must follow the ASEAN Common Submission Dossier Template (Annex 4 to the AMDD), which Member States are required to…

Visa-registration application documents for medical and dental devices must be written in Khmer, English or French (Prakas 1258, Art. 8)

Article 8 of Prakas 1258 requires the documents of an application for visa registration of medical and dental devices to be written in Khmer, English or French.

DDF publishes official sample application letters for medical-device/reagent registration, renewal and visa that cite Prakas 1258 and list the mandatory attachments

The DDF website's 'sample application forms for visa/registration' folder contains a Word file with three letter templates addressed to the Minister of Health — a request for registration (…

Mandatory and general label content of the applicable labelling annex

The labelling annex makes the product owner's name and contact details mandatory on the labelling, and requires the labelling of all devices to carry sufficient details to identify the devi…

Labelling must meet the placing Member State's requirements; the national-language requirement is optional for the State

A medical device must be labelled in accordance with the requirements of the Member State before it is placed on that State's market. Member States may set labelling requirements by referen…

ASEAN-level conformity assessment by the authority or appointed bodies, and the quality-assurance evidence required for each manufacturing facility

The quality system limb of Cambodian device control that is readable at instrument level is the ASEAN one. Article 5(1) of the ASEAN Medical Device Directive requires a medical device that…

TRC type approval of radiocommunication, telecommunication and ICT equipment

Wireless / radio

TRC qualified-agent certificate for importation, supply and distribution

Telecom terminal

TRC import permit for restricted radiocommunication and ICT goods

Import CoC / PVoC

The import permit for medicines, medical devices and cosmetics costs 200,000 riel per consignment, issued within 10 working days and valid six months (Joint Prakas 1356/2016 Annex 1 row 11; NTR Note 4)

Annex 1 row 11 of Joint Prakas 1356/2016 prices the letter authorising import of medicines, medical devices and cosmetics at 200,000 riel, with a 10 working day maximum service time and a v…

The fee for a variation application is the one fixed by joint prakas of the Ministers of Health and of Economy and Finance (Prakas 4206, Art. 8)

Article 8 of Prakas 4206 provides that the service fee for a request to vary a product holding a visa registration is determined by joint prakas between the Minister of Health and the Minis…

TRC qualified-agent certificate — importer, supplier and distributor of radiocommunication, telecommunication and ICT equipment · Application to the Telecommunication Regulator of Cambodia through its online portal by a firm registered in Cambodia; the certificate is a precondition for a type approval and for a restricted-goods import permit (Law on Telecommunications Article 16(a); Sub-Decree No. 110 ANK/BK Article 7(a))

15 working days

TRC type-approval certificate — per equipment model · Application to the TRC on the Prakas No. 208 basis, filed by a qualified agent and enclosing EMC, safety and RF test reports; the certificate is issued for each imported model and must exist before the equipment is imported (Law on Telecommunications Article 16(b); Sub-Decree No. 110 ANK/BK Article 7(b))

15 working days

TRC import permit — restricted radiocommunication and ICT goods · Application through the National Single Window for goods in Annex 2 of Sub-Decree No. 370 ANK/BK of 28 December 2023, filed by a qualified agent and supported by an existing type approval for the model

3 working days

When a variation changes certificate particulars a new certificate is issued dated from its issue but keeping the original expiry date (Prakas 4206, Art. 7)

Under Article 7 of Prakas 4206, if a variation affects information printed on the visa registration certificate, a new certificate is issued counted from its own date of issue while retaini…

The DDF renewal template requires a copy of the most recent device/reagent certificate and states the renewal round number (DDF sample renewal letter)

The DDF sample letter for renewal of validity of a device/reagent registration ('សំណើសុំបន្តសុពលភាពបញ្ជិកា…លើកទី…') carries a product table with an 'Old License No.' column and lists, in ad…

Variations are classed as major, minor or simplified minor according to the MoH Guideline on product variations of 26 March 2019, which serves as the technical reference (Prakas 4206, Arts. 4–5)

Article 4 defines a product variation as an update covering major and minor variations: a major variation is one that may strongly and/or directly affect quality, safety and efficacy (guide…

Devices differing in trade name, presentation, size or manufacturing plant must be registered separately (Prakas 1258, Art. 10)

Article 10 of Prakas 1258 provides that medical and dental devices with a different trade name, presentation, size or manufacturing plant must each hold a separate visa registration, so suc…

Importation and distribution records: contents and retention period

Dealers must establish documented procedures for maintaining importation and/or distribution records and maintain such a record for each medical device, including low risk devices exempt fr…

Traceability records must be kept and produced for inspection

Any person responsible for manufacturing or placing medical devices on the market of a Member State must keep all relevant records pertaining to the traceability of the device, for such per…

Clinical evidence may come from investigations conducted domestically or in other countries

In the common submission dossier, clinical evidence of effectiveness may comprise medical device related investigations conducted domestically or in other countries, and may be derived from…

A device for clinical investigation may be required to be registered with the authority where the investigation is conducted

For medical devices intended for clinical investigation, the Regulatory Authority of the Member State may require the product owner, its authorised representative or the sponsor of the clin…

Custom-made medical devices are not subject to product registration

Custom made medical devices are expressly not subject to product registration requirements. A custom made device is one specifically made in accordance with a duly qualified medical practit…

The authority may authorise use of unregistered devices in the interest or protection of public health

Notwithstanding the registration and conformity assessment duties, the Regulatory Authority of a Member State may, on a duly justified request or on its own initiative, authorise the use wi…

Dealer complaint-handling system and complaint-record retention of five years beyond projected useful life

Dealers of medical devices must maintain records of complaint reports and of the actions taken in response, produce those records for inspection by the Regulatory Authority when requested,…

Post-market clinical follow-up studies driven by residual risk, feeding the surveillance programme

The need for post market clinical follow up studies is determined from identification of residual risks that may affect the risk/benefit ratio, with circumstances including innovation in de…

Post-marketing alert obligations under the AMDD

Under the ASEAN framework binding Cambodia, anyone responsible for manufacturing or placing a device on the Cambodian market must keep traceability records and produce them for inspection,…

Field safety corrective action: duty to notify the authority and authority concurrence before closure

When a dealer decides to initiate a field safety corrective action it must notify the Regulatory Authority; the time frame for that notification is prescribed by the Regulatory Authority of…

Authority power to withdraw, prohibit or restrict a device that may compromise health or safety

Where the Regulatory Authority ascertains that a medical device placed on the market, when correctly installed, maintained and used for its intended purpose, may compromise the health or sa…

Medical device claims are subject to regulatory control and must be justified by substantial evidence

Medical device claims are subject to the regulatory control of the Member States, and as a general rule the claimed benefits of a device must be justified by substantial evidence or by the…

A classification dispute is decided by the authority and its decision is final

In a dispute between a Member State and any person over the classification of a medical device, the Regulatory Authority of that Member State decides the proper classification and its decis…