Uganda medical device registration resources

The National Drug Authority is the competent authority that registers surgical instruments and appliances

S.I. 2014 No. 29 makes the National Drug Authority the registering authority for surgical instruments in Uganda: every surgical instrument must be registered by the Authority before sale or…

DAR/GDL/028 Rev 0 is the operative device registration guideline, effective 14 August 2020

The National Drug Authority's operative registration guideline for devices is DAR/GDL/028 Rev 0, 'Guidelines on Registration of Surgical Instruments and Appliances', issued by the Directora…

Devices are regulated under the National Drug Policy and Authority Act, Cap. 206 s. 64(g) and S.I. 2014 No. 29

The statutory basis for medical device regulation in Uganda is the National Drug Policy and Authority Act, Cap. 206. Section 64(g) empowers the Minister responsible for health to make regul…

'Surgical instrument' is the statutory term and expressly includes appliances, IVDs, reagents and software

Uganda's device statute does not use the phrase 'medical device'. The regulated object is the 'surgical instrument', defined in reg. 24 of S.I. 2014 No. 29 as any instrument, apparatus, imp…

NDA Classes A, B, C and D

Class A, Class B, Class C, Class D

Three NDA tracks distinguish founding-IMDRF licensing, accepted quality-system or WHO evidence, and manufacturer conformity declarations

Registration is mandatory before sale or distribution, and an application is made before manufacture, importation or exportation (reg. 25(1), reg. 27(1)). NDA operates three registration tr…

China NMPA approval is not on the recognised-country list and opens no route of its own

statement: Uganda's recognised country list is closed and does not include China. DAR/GDL/028 s. 4.11 enumerates the recognised countries as the United States, Canada, Japan and Europe; Tab…

A legalised country-of-origin marketing approval is a mandatory dossier item for high-risk surgical instruments

statement: For surgical instruments or appliances classified or considered high risk, the applicant must submit a legalised approval issued by a health authority in the country of origin to…

An authorised local technical representative must declare responsibility for every application

S.I. 2014 No. 29 reg. 27(3) lists who may apply: the patent holder, a licensed person, the manufacturer of the surgical instrument, or an agent authorised by the manufacturer or patent hold…

No source-verified answer is published for this dimension yet.

A separate complete dossier per instrument, with class A and class B/C/D content sets

A separate and complete dossier in electronic form must be submitted for each surgical instrument, appliance, group or family. DAR/GDL/028 s. 4.3.3.1 sets out two content sets. For class A…

Form 7 (Schedule 6) is the device application form; Form 8 is the certificate; DAR/GDL/028 adds Appendices I-VII

The device application form is Form 7, prescribed by reg. 27(2) of S.I. 2014 No. 29 as Schedule 6 to those Regulations: 'APPLICATION FORM FOR THE REGISTRATION OF SURGICAL INSTRUMENTS', prin…

Nine mandatory label elements, to be provided in English, permanently and prominently

Reg. 29(1) of S.I. 2014 No. 29 requires the applicant to submit with the registration application a label carrying: the name of the surgical instrument; the name and address of the manufact…

NDA recognises ISO 13485:2016 as the basis for cGMP, and inspects all local and foreign manufacturers

NDA recognises the medical devices quality management systems requirements of the ISO 13485:2016 standard as the basis for the regulated medical devices current good manufacturing practices…

UCC type approval of communications equipment

Wireless / radio

UCC approval at importation or sale of communications equipment

Telecom terminal

Application for registration of imported surgical instruments and appliances

USD 1500

Application for registration of locally manufactured surgical instruments and appliances

USD 200

Surgical instruments and appliances — registration by the Authority · Application to the National Drug Authority for registration of a surgical instrument before manufacture, importation or exportation, on Form 7 of Schedule 6 to S.I. 2014 No. 29 (reg. 27(1)-(2)), filed by the patent holder, a licensed person, the manufacturer, or an agent authorised by the manufacturer or patent holder (reg. 27(3)); registration is a precondition of sale or distribution (reg. 25(1))

60 days

A first registration certificate is valid five years and a renewal certificate one year

Under S.I. 2014 No. 29 the term of a device registration is finite. The Authority issues a certificate of registration for a first registration which is valid for five years; the holder mus…

Variations are filed on Appendix V and must be applied for before the change is made

Whenever a holder of a certificate of registration wishes to make an amendment or alteration to the particulars provided in the application for registration, the holder must apply to the Au…

A device identifier must appear on the label, and the manufacturer must use serial or batch identification; no UDI database exists

Uganda imposes label level device identification and manufacturer record keeping, not a UDI system. Reg. 29(1)(c) of S.I. 2014 No. 29 requires the label to carry 'the identifier of the surg…

Clinical evidence and a clinical evaluation are required per the IMDRF Essential Principles; human-subject investigations follow Helsinki

Uganda routes clinical requirements through the IMDRF Essential Principles checklist that DAR/GDL/028 Appendix II adopts. Essential Principle 7.0 provides that every medical appliance requi…

Registration guideline does not apply to surgical instruments/appliances imported as a donation or gift (DAR/GDL/028 §1.3)

The device registration guideline expressly excludes from its scope surgical instruments and appliances that are the subject of a patent application or a donation/gift; donated devices ther…

Importation for donation requires prior notification and written NDA authorisation with conditions; donated products must come from an approved source with at least one year shelf life (S.I. 34 of 2014, regs 13-14)

Under Part III of the Importation and Exportation of Drugs Regulations 2014, importation for donation is allowed only where the recipient or donor informs NDA of the necessity directly rela…

The certificate holder must monitor safety and effectiveness and file periodic reports; annual PMS reports for high-risk products

S.I. 2014 No. 29 reg. 40(5) places a continuing market obligation on the holder of a certificate of registration: the holder 'shall monitor the safety and effectiveness of the registered ..…

No source-verified answer is published for this dimension yet.

The manufacturer determines recalls and NDA may suspend a registration with notice and a hearing

On the manufacturer's side, INS/GDL/047 s. 7.1.1.8 requires the manufacturer to determine product recalls and other field actions that are relevant for products already distributed, s. 7.1.…

No source-verified answer is published for this dimension yet.

A written objection to a registration decision may be filed with NDA; refusals must give reasons and a hearing

DAR/GDL/028 s. 4.9 provides the appeal route for devices: any objection to a decision of the registration in relation to any application for registration or listing of a surgical instrument…