🇧🇳 Brunei medical device regulatory data

Section 53(1)(a) of the Medicines Act prohibits publishing any medical advertisement that directly or indirectly claims, indicates or suggests that the article advertised will prevent, alleviate or cure any disease or condition in the Schedule, which lists 22 entries including AIDS, asthma, cancer, conception and pregnancy, deafness, diabetes, diseases of the eye, heart and kidney, epilepsy, hypertension, infertility, sexual function and tuberculosis. Advertisements distributed only to medical practitioners, dentists, pharmacists, nurses, midwives, veterinary surgeons and their trainees are exempt (s. 53(2)). The penalty is a fine of up to $5,000, up to 2 years' imprisonment or both (s. 53(3)).

Section 52 of the Medicines Act makes it an offence to issue a false or misleading advertisement or representation 'relating to medicinal products', including an advertisement inconsistent with the information approved at registration under s. 11; it does not extend to devices. Section 54(1)(b) empowers the Minister by order to prohibit advertisements likely to lead to the use of 'any medicinal product, or any other substance or article' for treating or diagnosing specified diseases, and s. 54(2)(b) allows orders requiring prior approval of advertisements by the Authority; no such order reaching devices is listed among the Act's subsidiary legislation.

Part 8 of the Medicines Act defines 'medical advertisement' as an advertisement relating, or likely to cause a person to believe it relates, to any medicinal product 'or any device, instrument, apparatus or contrivance used or represented to be used for a medicinal purpose'. This is the only provision of Brunei law that expressly regulates medical devices, and it does so through advertising control rather than product approval.

The only validity and renewal rules in Brunei health-product law are for medicinal products: the registration period is as specified in the product licence and, where none is specified, the registration is valid until cancelled (s. 11(6)-(8)); import, manufacturer's and wholesaler's licences are valid for one year and a clinical trial import licence for up to 3 years (s. 15(4)-(5)); licences are non-transferable (s. 15(6)). No validity period or renewal applies to a medical device because no device approval exists.

AITI Dealer Type Approval is valid from a minimum of one year up to five years from issuance, and a licence under the Radiation Protection Act remains in force for such period as may be specified in the licence unless earlier suspended or cancelled, with renewal on application to the Authority.

The Brunei Darussalam Medicines Control Authority established by s. 5 of the Medicines Act is the only product-regulatory authority created by Brunei statute, and s. 6 confines its functions to registration, licensing and listing of medicinal products and to the import, manufacture, distribution, labelling and disposal of medicinal products. The Act read in full confers no function over medical devices or in-vitro diagnostics on the Authority or on any other body.

Under the Radiation Protection Act (Chapter 228) the Minister appoints an Authority charged with the Act's administration, and that Authority licenses the import, possession, use, manufacture and sale of 'controlled apparatus', defined as apparatus that produces ionising radiation when energised or because it contains radioactive material. This is the only statutory authorisation regime in Brunei that captures a class of medical equipment.

The only change-control rules in Brunei health-product law are for medicinal products: an applicant must notify changes to application information within 14 days (Act, s. 11(5)), and a product licence holder must forthwith inform the Authority of any material change in the specification, constituents, composition, manufacturing methods, quality procedures, storage arrangements, indications, label or leaflet of the medicinal product (Rg 2, Schedule 1, para. 2). The Ministry of Health's variation routes (MaV, MiV-PA, MiV-N) are for registered medicinal products. No variation or change-notification route exists for medical devices.

For Dealer Type Approval, AITI categorises equipment into three levels by the risk that non-compliance would cause interference to the radio-frequency spectrum and telecommunications network: Level 1 low risk (example: short range devices), Level 2 moderate risk (example: marine radio) and Level 3 high risk or impact on personal safety (example: repeater station). A medical device is graded only if it is telecommunications or radio-communications equipment.

Brunei has no medical-device risk-class axis. The only classification in the Medicines Act is the supply classification of medicinal products into general-sale-list products (s. 24), products sold only from a registered pharmacy under a pharmacist's supervision (s. 25) and prescription-only products (s. 30); the Act and its regulations contain no class A to D, class I to IV or other device grading.

Section 23(1) of the Medicines Act prohibits conducting any clinical trial in Brunei Darussalam without prior written approval from the Brunei Darussalam Medicines Control Authority. The Act's s. 2(1) defines a 'clinical trial' as investigations on persons to determine 'the safety, effectiveness and other effects of any product', and 'product' is not defined, so the approval requirement is not on its face limited to medicinal products. No rules under s. 23(2) prescribing trial conditions, and no device-specific investigation guidance, have been published.

No Brunei statute or regulation defines 'medical device' or 'in-vitro diagnostic'. The Medicines Act's s. 4(1) definition of 'medicinal product' excludes 'an instrument, apparatus or appliance' and requires that the substance or article be for use by being administered to human beings or animals, or as an ingredient of something so administered, so neither devices nor reagents used outside the body fall within the Act's registration regime.

AITI's Table 1 requires, for Dealer Type Approval, technical specifications and/or an equipment brochure and a picture of the equipment at Level 1, and additionally a test report or certificate of conformity for the equipment at Levels 2 and 3. For Levels 2 and 3 the declaration of conformity must rest on certification or test reports showing design and construction in accordance with international standards recognised by the Authority.

The Medicines Act prescribes no dossier for any product beyond s. 11(2), under which an application to register a medicinal product must be accompanied by the prescribed processing fee and 'such documents, items, samples, particulars and other information as the Authority may require', and s. 13, under which the Authority may require a manufacturer's declaration of compliance with the laws of the country of manufacture. No technical-file, CSDT, STED or other device dossier requirement exists in Brunei law or Ministry of Health guidance.

The only economic-operator roles in Brunei health-product law are those created by s. 15(1) of the Medicines Act: the holders of an import licence, a manufacturer's licence, a wholesaler's licence and a clinical trial import licence, each defined by reference to 'registered products', together with the product licence holder under s. 11(8). No Brunei instrument creates a local authorised representative, responsible person or registrant role for medical devices.

The Royal Customs and Excise Department's table of goods requiring an import permit from a responsible agency contains no row for medical devices, medical equipment, surgical instruments or diagnostic kits. The only Ministry of Health Pharmaceutical Services category is 'Medicines, Herbal, Cosmetics', whose tariff list (HSC-K) covers chapters 27 to 38 only and contains no heading of chapter 90 or headings 3005, 3006 or 4015. General (non-radiating, non-radio) medical devices are therefore imported on an ordinary customs declaration without a health-agency permit.

The Department of Pharmaceutical Services' licensing guideline states that all medicinal products are regulated under the Medicines Order, 2007, that the Import Licence and Wholesaler's Licence are required for the importation, storage and supply of medicinal products, and that the licence authorises the import, storage and wholesale of registered medicinal products. No establishment licence, import licence or wholesale licence is required for a medical-device importer or distributor.

The customs list HSC-N designates every tariff line of heading 9022, including computed tomography apparatus, dental X-ray apparatus, other X-ray apparatus for medical, surgical or veterinary uses, and X-ray tubes, as controlled/restricted goods whose import permit is issued by RSQU (EIDPMO), the Radiation Safety and Quality Unit under the Prime Minister's Office.

AITI's Schedule 2 prices Dealer Type Approval per brand and model by equipment level and validity: Level 1 (telephone systems, fax, PABX, fixed ADSL modem, audio and video conferencing, short range devices, VoIP) BND 20 for 1 year up to BND 100 for 5 years; Level 2 BND 30 to 50 per year depending on equipment type; Level 3 (mobile phones, wireless modems, base stations, radar, radio data transceivers, high-power radio, walkie-talkies, repeater stations) BND 50 for 1 year up to BND 250 for 5 years. Schedule 3 prices the Dealer Import Permit at BND 20 per unit for listed equipment only, with short range devices, modems and mobile phones among the exempt types.

Schedule 5 of the Medicines (Licensing, Standard Provisions and Fees) Regulations is Brunei's only fee tariff for health products. Its five heads are product licence (processing fee $200; first year no charge; $50 each subsequent year; major amendment $150, minor $50), import licence, wholesale dealer's licence ($100 per year), manufacturer's licence and certificates (certificate to export a medicinal product $50; statement of licensing status $25). No head prices any medical-device application, because none exists.

Brunei's only product-labelling instrument is the Medicines (Labelling) Regulations, made under s. 81(1) of the Medicines Act, whose rules cover dispensed medicinal products, clinical-trial products, products containing Schedule 1 substances (which must carry a statement in English declaring the substance) and date-stamping of Schedule 2 products. Sections 46 and 47 of the Act confine the labelling and leaflet rule-making powers to medicinal products. No labelling, instructions-for-use or language requirement exists for medical devices or IVDs.

The only Brunei statute that imposes a product-registration requirement is the Medicines Act, Chapter 285, and it expressly excludes medical devices: 'medicinal product' is defined as 'any substance or article (not being an instrument, apparatus or appliance)', and both the prohibition on unregistered supply (s. 10(1)) and the power to register (s. 11(1)) attach only to a 'medicinal product'. No Medical Devices Act, Order or Regulations exists in the Laws of Brunei Darussalam.

The only post-market duties on manufacturers in Brunei health-product law are the standard provisions of the product licence in Rg 2 Schedule 1: to inform the Authority forthwith of information casting doubt on the safety, quality or efficacy data submitted (para. 3), to report adverse-effect reports within 7 days (para. 4), to withhold or withdraw batches found harmful or non-conforming if directed (para. 6) and to notify any withdrawal decision (para. 7), each expressed for 'any medicinal product to which the licence relates'. No manufacturer post-market surveillance, periodic safety update or trend-reporting duty exists for medical devices or IVDs.

AITI may direct a person who operates equipment to cease operating it and may direct an importer to produce equipment for testing or inspection; the person must comply at his own expense and, at his own expense, send the equipment for certification or testing by any local or foreign body recognised by the Authority.

The only quality-system control in the Medicines Act is that import, manufacturer's and wholesaler's licences for medicinal products 'shall only be issued after an inspection' (s. 15(1)), and the inspection power in s. 60(1) is limited to substances or articles appearing to be medicinal products, their containers, labels and leaflets, and plant used to manufacture medicinal products. No quality-management-system, ISO 13485, GMP certificate or audit requirement applies to a medical-device manufacturer, importer or distributor.

Section 75(1) of the Medicines Act empowers the Authority to issue directions, in particular relating to the recall from the market and the disposal of any registered medicinal product, and s. 75(2) makes contravention an offence. The Act contains no recall, field safety corrective action or market-withdrawal power over medical devices, and its seizure and forfeiture powers (ss. 60(4), 62 to 64) operate on articles connected with offences under the Act, which a device cannot be.

The Ministry of Health's Guidance for Medicinal Product Defect, Quarantine and Recall states that it applies to licensed manufacturers, wholesalers, importers and product licence holders for registered medicinal products and unregistered medicinal products imported via import permit on special approval, and reproduces the Medicines Order's exclusion of instruments, apparatus and appliances. Its recall classes (Class 1 to 3), recall levels and defect-reporting forms (Annex II to IV) therefore do not apply to medical devices.

AITI's Advisory Guidelines require both a Type Approval and an Import Permit to import telecommunications or radio-communications equipment for personal or commercial use, and Type Approval must be obtained first. Dealer Type Approval is required for commercial import and only a holder of a valid Dealer Licence may apply; Level 1 Type Approval is also called Equipment Registration.

Section 10(1) of the Medicines Act prohibits the manufacture, sale, supply or import of an unregistered 'medicinal product', and s. 11(1) empowers the Authority to register only 'any medicinal product'. Because s. 4(1) excludes instruments, apparatus and appliances from that term, no pre-market registration, notification or product licence exists or can be applied for in respect of a medical device or IVD.

Section 7(1) of the Radiation Protection Act prohibits importing, exporting, keeping, possessing, using, manufacturing, selling or dealing in any 'controlled apparatus' except under and in accordance with a licence granted by the Authority under s. 8. Contravention carries a fine of up to $100,000 and up to 5 years' imprisonment for an individual, or a fine of up to $10,000,000 for a body corporate.

AITI's Table 1 states the processing time for Dealer Type Approval as 'Immediately' for Level 1 equipment and 'Seven (7) working days' for Level 2 and Level 3 equipment.

The Medicines Act contains no time limit within which the Authority must decide an application for registration or a licence; the only periods it fixes are the applicant's 14-day duty to notify changes to application information (s. 11(5)) and the 14-day appeal window (s. 21). Section 14 allows the Authority to reject a registration application without assigning any reason. No published review timeline exists for medical devices because no device application exists.

The exemptions in s. 18 of the Medicines Act (research or registration samples, pharmacy dispensing, teaching institutions, clinical-trial or registration samples, and manufacture or import 'solely for the purpose of treatment of any person suffering from a life-threatening illness') and the Ministry of Health's Import Permit with Special Approval all relieve the s. 10(1) duty for medicinal products. Because devices are outside s. 10(1) altogether, no special-access, named-patient or emergency-use derogation exists or is needed for a medical device.

The only standards provision in Brunei health-product law is s. 35 of the Medicines Act, which requires a medicinal product sold under a monograph name to comply with the monograph in the British, European or United States Pharmacopoeia or other named publications. No Brunei instrument recognises ISO, IEC or other standards for medical devices, and no device testing or certificate is required by the Ministry of Health.

Section 21 of the Medicines Act gives a person aggrieved by an Authority decision under s. 20 (suspension or cancellation of a medicinal-product registration, or suspension, revocation or variation of a licence) a written appeal to the Minister within 14 days of the decision being made known, the Minister's decision being final. No appeal lies against a rejection under s. 14, which may be made without reasons. Because no device application, deficiency or decision process exists, no device communication or appeal route exists.

An applicant dissatisfied with a decision of the Radiation Protection Authority under s. 8 (grant, renewal, conditions, refusal, suspension or cancellation of a licence), s. 14 or s. 15 may appeal to the Minister in writing within 30 days of communication of the decision. The Minister appoints one or more persons to hear the appellant and the Authority, may inspect the premises or controlled apparatus, and may dismiss the appeal, require a licence to be issued, quash or substitute a suspension or cancellation, or vary the decision; the Minister's decision is final.

Section 12 of the Medicines Act requires the Authority to keep a register of medicinal products and cosmetic products, and Rg 2 Schedule 1 para. 8 requires the product licence holder to state the licence number on the label and package. No unique device identifier, device listing, registration number or traceability requirement applies to medical devices or IVDs in any Brunei instrument.

Under the Radiation Protection Act every person who sells a controlled apparatus and every person who purchases one must immediately notify the Authority with the other party's name, address and prescribed particulars, disposal requires prior written approval, and the Authority keeps registers of licences (s. 9). This is the only statutory traceability duty attaching to any class of medical equipment in Brunei.

Section 74 of the Medicines Act requires a licensed manufacturer, wholesaler, importer or product licence holder to notify the Authority immediately of any adverse reactions arising from the use of the registered medicinal product. The Act read in full contains no adverse-event, incident or malfunction reporting duty for medical devices or IVDs, and no timeline or form for such reports exists.

Brunei's Pharmacovigilance Guidelines adopt the Medicines Order, 2007 s. 4 definition of 'medicinal product', which excludes 'an instrument, apparatus or appliance', and require licence holders to report serious adverse drug reactions to the National Adverse Drug Reaction Monitoring Centre no later than 7 calendar days after first awareness, with follow-up within 8 additional calendar days. The Guidelines contain no device incident-reporting provision.