Ministry of Health and Medical Education of the Islamic Republic of Iran
Ministry of Health and Medical Education of the Islamic Republic of Iran
Minister’s Office
Medical Devices Bylaw
Introduction
In order to organize and supervision production, imports, customs release, exports, transportation, storage, distribution, supply, installation, operation, after-sales services, maintenance, pricing and disposal of medical equipments including consumables, semi-consumables, machinery, diagnostic, surgery, medical laboratory diagnostic, treatment, care, dentistry, rehabilitation and material for production of these products according to paragraphs nos. 11, 12, 13 and 17 and Article 1 of theLaw for Organization and Duties of the Ministry of Health and Medical Education and Article 8 of the Establishment Law of the Ministry of Health and Medical Education and Provision 2 of Article 3, Provision 5 of Article 13, Provision 2 of Article 14 and Articles nos. 25 and 25 of the Medical, Pharmaceutical, Foodstuff and Drinks Affairs Regulations, The Medial Devices Bylaw is hereby approved and confirmed as follows:
Chapter 1) Terms and Definitions
Article 1)The terms and definitions of this bylaw shall be used with the context set forth herein:
A) Legal Entity: Any company, institute, organization, research and education centers, universities, NGOs and any other body that are legally formed and are bound to be called legal entities and according to this bylaw and associated directives and objectives in their Articles of Association are allowed to be active in sales, supply, manufacture, imports, release, storage, maintenance, transportation, distribution, exports, after-sales services, support, training and research activities, quality control and consultation of medical devicesin the country.
B) Natural Entity: Any person with active and valid commercial ID card, holders of valid business license and practitioner of medical professions that according to the present bylaw and associated directives are allowed to be active in sales, maintenance, exports, after-sales services, support, training and research activities, quality control and consultation of medical devicesin the country. Supply, manufacture, imports and release of medical devicesby natural entities shall be allowed only in special cases by approval of the technical committee.
C) Technical Officer: Any individual working in the manufacturing, imports, distribution or supply units of medical devices, medical profession institutes and practitioners that after being introduced by the highest authority of their unit and approval of the technical committee for medical devices are in charge of scientific and technical supervision in order to properly implement related laws and regulations especially for production, imports, release, exports, distribution, supply and after-sales services of the unity according to associated directives.
D) Medical Institute: Any treatment centers and medical, treatment and pharmaceutical units stipulated in Article 1 of the Medical, Pharmaceutical, Foodstuff and Drinks Affairs Regulations ratified in 1955 and its subsequent amendments and attachments.
E) Medial Practitioner:Any member of the Medical Council of IR Iran who is authorized to practice medicine at private office according to related rules and regulations.
F) Directive:A set of regulations about various measures, requirements and processes including production, imports, release, exports, transportation, storage, distribution, supply, installation, operation, after-sales services, pricing, disposal, maintenance and material for production that is approved and published separately according to the present bylaw and according to Article 2.
G) Medical Devices:Medical, dentistry and laboratory devices, instruments, apparatus, tools and equipments hereinafter called in general “Medical Devices” include any commodity, tool, equipment, machinery, device, implant, material, laboratory reagents and calibrators and software that are produced for the sole purpose of human use on their own or in conjunction with other related items in order to achieve one of the following objectives:
- Diagnosis, monitoring, prevention, treatment or reduction of a disease
- Protection or support ofvital process
- Pregnancy and conception control and prevention
- Sterilizing, sanitizing and cleaning tools, environment and medical wastes in order to conduct appropriate medical, treatment and healthcare actions
- Providing information to achieve medical objectives through laboratory methods carried out on samples taken from human body
- Diagnosis, monitoring, treatment, alleviation, compensation and/or delaying injury or disability
- Investigation, study, replacement or modification of a physiological or anatomical process.
Provision 1: This definition does not cover material with main effect or design purpose on human body is based on pharmaceutical, immunological and/or metabolic methods and also sanitizing and sterilizing materials.
Provision 2: Products, material, reagents, calibrators, sample collection and preservation tools and control solutions for laboratory and dentistry use that the legal definition of drug cannot be applied to them fall under the definition ofmedical devices.
H) Local Producer:Any legal entity that produces medical devices inside the country by having required licenses for the purpose of supply in accordance with the stipulations set forth herein under its own name and responsibility.
I) Importer:Any legal entity that imports medical devices to the country according to related rules and regulations of the country in accordance with stipulations set forth herein.
J) Exporter:Any legal or natural entity active in the field of medical devices inside the country or their legal agent/representative that export medical devices in accordance with related rules and regulations.
K) After-Sales Services: A set of obligations and actions implemented by the producer, import or their legal representative and authorized legal entities in order ensure appropriate performance and adherence to safety principles during the term of such obligation. The aforesaid implementations include delivering medical devices according to the concluded contract, installing, operation, performing acceptance tests, training, guarantee including warrantee, supply of parts, minor and major repairs, quality control, quality, performance and calibration tests, upgrading and updating, product tracking, follow up on customer’s request, performing modifications and recall of the product.
L) Establishment Law: The Establishment Law of the Ministry of Health and Medical Education ratified in 1985by the Islamic Consultative Assembly.
M) Organization Law:TheLaw for Organization and Duties of the Ministry of Health and Medical Education ratified in 1988 by the Islamic Consultative Assembly.
N) Medical Affairs Law:Medical, Pharmaceutical, Foodstuff and Drinks Affairs Regulations ratified in 1955 and subsequent amendments and attachments.
O) Ministry:Ministry of Health and Medical Education of IR Iran
P) Organization: Food and Drug Organization of the Ministry
Q) Administration:Medical devices Supervision and Evaluation Administration of the Organization
R) University:Any medical education and healthcare universities/schools in the country.
Article 2) In order to achieve the objectives set forth in this bylaw to organize and supervise activities in the field of medical devices, organization and administration shall publish relative directives including those supervising production, imports, release, exports, transportation and storage, distribution, supply, purchase, installation, operation and after-sales services of medical devices. Observing the aforesaid directives by any legal or natural entity involved in the field of medical devices and medical institutions and centers under Article 8 of the Establishment Law, Article 12 of its executive bylaw and medical practitioners is mandatory.
Article 3) Managing directors, technical officers, holders of commercial ID cards and license of commercial units active in the field of medical devices in addition to observe rules and regulations related to their business are required to provide the organization or administration documents as required about registration of the company, agency letter from domestic or foreign companies, articles of association, license and any other legal document and deeds according to the directives.
Article 4) On the strength of the authority and duties specified in Article 24 of the law adjusting a section of government financial regulations and its executive bylaw, the administration is obliged to perform the following in order to prepare, organize and perform affairs related to issuance of imports and production permit and license of medical equipments and their technical responsibility:
1)Creating an ID for any legal entity applying for activity in the field of medical devices
2)Issuing medical devices registration license for production, imports and release
3)Issuing license for any legal entity applying for activity in the field of medical devices
4)Extending license for any legal entity in order to continue activity in the field of medical devices
Article 5) Executive process for registration of medical devices, creating ID and issuing license shall be explained in detail through the published directives.
Article 6) Registering medical devices and issuing, extending, modifying and suspending a license depend upon agreement by the medical devices technical committee.
Article 7) Specification of duties and authorities of legal entities and allowed content on the license and its validity term shall be according to suggestion by the administration and confirmation of the medical devices technical committee.
Article 8) In order to make decision regarding special cases and providing suggestion and solutions for production, imports, release, exports, transportation and storage, distribution, supply, purchase, installation, operation and after-sales services of medical devices and also investigating the competence of technical officers for working in production, importing, distributing, treatment and service units of medical devices and any duties and authorities that is stipulated by this bylaw, “medical devices technical committee” hereinafter “technical committee” is formed in the administration with the following job description and members composition:
1)President of the organization as the chairman
2)Treatment deputy of the ministry
3)Director general of the administration as member and secretary
4)Chairman of the board of trustees of foreign currency expenditure control for patients treatments
5)Three faculty members of medical education and healthcare universities/schools as recommended by the president of the organization and approved by the minister
6)Two individuals of medical devices production, distribution and imports industry as recommended by the president of the organization and approved by the minister
Article 9) Sessions of the technical committee will be held regularly and in coordination with the administration and shall be made official with a quorum of the two third of the members and any decisions shall be valid if voted by the majority.
Article 10) The administration is allowed to invite an active expert of medical devices from related specialized societies and associations and two experts proficient with the subject presented in each session of the technical committee in addition to the fixed members. The aforesaid shall have no voting rights.
Article 11) As approved by the technical committee, specialized and consultation workgroups can be formed.
Article 12) The administration is tasked to refer the following cases to the technical committee for investigation and prompt decisions:
1)Directives within the executive scope of the present bylaw
2)Verifying or suspending the competence of medical devices technical officer
3)Special cases regarding supply, manufacture, production, imports, release, after-sales services, distribution, sales, investigating and making decision about occurred violations
4)Other implementations according to the stipulations set forth herein after approval by the members of the committee
Chapter 2) Safety and Performance of Medical Devices
Article 13) Any natural or legal entity active in the field of medical devices isrequired to verify and prove compatibility of the produced, imported and sold medical devices with principal requirements of “Safety and Performance Principles”.
Article 14) Anylegal or natural entity is required to provide the administration documents and evidences according to relevant directives in order to prove the safety and performance of medical devices.
Article 15) Anylegal or natural entity is obliged to observe medical equipments classification directives and be aware of the risk level of the relevant devices according to directives for any activity regarding production, imports, release, exports, transportation and storage, distribution, supply, purchase, installation, operation and after-sales services of medical devices.
Article 16) Benefits of using the medical device must be much higher compared to costs and side effects of the applying that medical device.
Article 17) In order to introduce emerging technologies anylegal or natural entity is obliged to provide healthcare technology evaluation report to the healthcare technology evaluation workgroup. The healthcare technology evaluation workgroup shall be formed according to Article 11 of the present bylaw in which representatives of treatment deputy and organization shall participate.
Article 18) Producer or importer or their legal agent is obliged to train the operators of medical equipments about usage, maintenance and safety of the devices according to applicable directives.
Article 19) Medical institutes are required to utilize expert and trained personnel in operating medical devices and observe the safety of the operator, patient and environment during the useful lifetime of the device in coordination with the producer/importer or their legal agent.
Article 20) A direct and competent operator medical devices including physician, nurse or other members of medical groups who according to Article 18 have received necessary training in operating medical devices must report immediately any defect and flaw in performance and safety conditions of the device they observe to the medical devices officer, director or expert of the medical institute.
Article 21) In addition to having all the performance conditions stated by the producer medical devices at the time of design, production and packaging must be designed, produced and packaged in a way that the safety of the patient, operator and any relevant individual is not compromised.
Article 22) Observing scientific and technical principles in transportation and storage of medical devices and observation of information provided by the producer/import or their legal agent in order to maintain performance and safety conditions of medical equipments is mandatory.
Article 23) Considering the importance of providing information about performance or safety conditions and the nature of the medical devices, any natural or legal entity is required to properly label medical equipments according to directives. Any document accompanying the medical devices and any of their labels that are intended for non-professional and home use must be prepared in Persian language and provided to the user as required.
Article 24) The responsibility for performance and safety of the sold medical devices lies with the producer/importer and their legal agent.
Article 25) Any non-compliance of safety and performance of the medical devices with that of claimed by the producer that results in physical, financial and environmental damage, the producer/importer or their legal agent shall be held responsible to compensate the aforesaid damages.
Chapter 3) Production
Article 26) Production of medical devices is using of processes such as research, design, forming, changing, converting and processing materials, parts, hardware and software by observing requirements and according to related safety and performance principles and as per relevant directives which results in production and supply of a type of medical device as final product.
Article 27) Production methods of medical devices include the following:
27-1) Independent: designing medical devices and their main parts or processes completely carried out by the producer and the producer is able to develop and upgrade newer models independently and some and/or all of the parts are manufactured by the producer at production site and/or are manufactured by local manufacturers and/or in case of lack of local technology by other manufacturers.
Managing all manufacturing products of the final product according to Article 26 is upon the producer. Determining the contribution percentage of the producers towards production of medical devices and proficiency over designing shall be made by the administration.
27-2)Assembly: procuring or importing parts and assembling them in order to manufacture final product and perform quality control processes.
27-3) Packaging, labeling and/or sterilizing: A legal entity packaging, sanitizing, labeling and/or sterilizing medical devices and supplying the product to the market under the entity’s own responsibility and trade name.
27-4) Own brand labeling (OBL): A legal entity supplying the final product of a local producer with its own trade name.
Article 28) For each of the aforesaid methods a separate license shall be issued.
Article 29) Applying the title of “Made in Iran” to medical devices and issuing related certificates shall be according to directives and contribution percentage of the local manufacture.
Article 30) Issuing a registration license according to percentage of local manufacture of medical devices in the independent production method shall be according to Article 29 “Made in Iran” regulation and as per the stipulations set forth in paragraph 1 of Article 27.
Article 31) Support policies for local production such as requiring public organizations to supply the locally produced medical devices, limiting the imports of similar medical devices and such shall be according to percentage of local production of medical devices and according to applicable directives.
Article 32) Producing medical devices for distribution, sales and exports shall be allowed after registering such medical devices in the administration.
The producer is required to prepare and provide technical documents of the medical device and any other document required byapplicable directives in order to obtain the license for that medical device.
Article 33) On the request of the applicant, provisional license for producing medical devices ontest sample basis can beobtained provided that compatibility of the medical device with performance and safety principles is verified. Any medical devices produced on test sample basis are not allowed for distribution, sales or exports.
Article 34) Procuring and using material in production from domestic or foreign sources shall be carried out by providing required documents according to applicable directives and approval of the administration.
Article 35) Providing production statistics by the producer on quarterly basis to the administration is mandatory.
Article 36) For some of the medical devices such as those in high risk category, clinical diagnosis kits and implants, production, distribution and sales license shall be issued for each batch release separately by the administration.