REPUBLIC OF COLOMBIA 
 
 
MINISTRY OF SOCIAL WELFARE 
 
 
RESOLUTION NO.                    OF 2008 
 
 G/TBT/N/COL/108 
Establishing the technical and sanitary requirements for establishments which 
manufacture, process, adjust, store, market, distribute or dispense prescription medical 
devices for visual and ocular health 
 
 
THE MINISTER OF SOCIAL WELFARE 
 
 
Acting within powers conferred by law, and in particular those conferred by Decrees 
numbered 205/2003 and 1030/2007 
   
AND HAVING REGARD TO THE FOLLOWING CONSIDERATIONS : 
 
Article 78 of the Political Constitution of Columbia states: “[…] Those who, in the production and marketing of goods and services endanger the health, safety and adequacy of supply to consumers and users, shall be liable under the law. [...]”;
 
 
Under the terms of Law 170/1994, Colombia approved the World Trade Organisation 
Agreement containing, inter alia , the Agreement on Technical Barriers to Trade, which 
recognises the importance of Member States adopting the necessary measures to protect vital interests in the area of the safety of all products including industrial and agricultural products, such measures to include the issuance of technical regulations;  
 
 
Guidelines for the preparation, adoption and application of technical regulations in Member 
States of the Andean Community and at the level of the Community are set out in Decision 562 of that Community, and the administrative procedure for the preparation, adoption and application of technical regulations and sanitary measures is laid out in Decree 4003/2004, all of which have been taken into account when drawing up the technical regulation 
introduced by the present resolution; 
  Chapter II of Decree 1030/2007 stipulates that the Ministry of Social Welfare shall set the technical and sanitary requirements for es tablishments which manufacture and market 
prescription medical devices for visual and ocular health;  
 
  
Accordingly, it is necessary to define the technical and sanitary requirements to be 
complied with by establishments which manufacture, store and dispense prescription medical devices for visual and ocular health in Colombia;   In accordance with the foregoing, now hereby 
 
   
 
 
RESOLVES 
 
    RESOLUTION NO._________        OF 2008            PAGE No                                              2 
 
 
Continuation of the Resolution “ Establishing the technical and sanitary  requirements for establishments which 
manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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ARTICLE 1. The aim of this resolution is to adopt the Manual of technical and sanitary 
requirements for establishments which manufacture, process, adjust, store, market, 
distribute or dispense prescription medical devices for visual and ocular health, as set out in Technical Annex N° 1, and the list of prescr iption medical devices for visual and ocular 
health set out in Technical Annex N° 2 which forms an integral part of this Resolution.  ARTICLE 2. This Resolution enters into force on the date of its publication and repeals all 
contrary provisions. 
    
TO BE PUBLISHED AND COMPLIED WITH 
 
   
Bogotá D.C., (date)……….. 
 
    
 
   
 
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TECHNICAL ANNEX No 1 
 
MANUAL OF TECHNICAL AND SANITARY REQUIREMENTS FOR ESTABLISHMENTS WHICH MANUFACTURE, PROCESS, ADJUST , STORE, MARKET, DISTRIBUTE OR 
DISPENSE PRESCRIPTION MEDICAL DEVICES FOR VISUAL AND OCULAR HEALTH   
I. PURPOSE AND SCOPE  
 
The purpose of this manual is to establish the technical and sanitary requirements for establishments which manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and ocular health.   II.  DEFINITIONS
 
 
For the purposes of this Manual, the definitions given in Decree 1030/2007 shall be used, 
as well as those given below:  
 
Adjustment. The activity of adjusting or altering a prescription medical device for visual 
and ocular health to meet the specifications of a prescription issued by a professional in the field of visual and ocular health.
 
   Storage. The activity of maintaining prescription medical devices for visual and ocular 
health and raw materials in conditions which ensure they will not suffer deterioration or 
alteration affecting the quality of the products.  
 
 
Environment.  The physical conditions or situation of an individual location.  
  
Controlled environment.  A location or space controlled as regards both viable and non-
viable particles. The controls shall also cover temperature and humidity.  
 
Approved. The condition of a raw material or product, or of any material in general which 
guarantees that it is ready for use.  
 
Area.  A physically separate space contained between certain limits.  
 
White area: A physically separate space in which the contaminant load, such as viruses, 
bacteria, fungi and suspended particles, is guaranteed to be controlled. These areas have controlled lighting and air supply. Access is restricted. 
 
  
Grey area: A physically separate space in which the contaminant load, the lighting 
conditions and air supply are not guaranteed to be controlled. Access is semi-restricted.  
  
Black area:  A physically separate space in which the contaminant load, the lighting 
conditions and air supply are not guaranteed to be controlled. Access is not restricted.  
 Quality assurance.  All the planned and systematic activities undertaken within a quality 
management system which create the confidence  that a prescription medical device for 
visual and ocular health will meet quality standards.  
 
 
Technical audit. A systematic, independent and documented process to obtain evidence 
of audit and to assess it objectively with a view to determining the extent to which audit criteria are being complied with.
 
 Quality. The range of properties of raw materials or prescription medical devices for visual 
and ocular health which ensure they are effective and safe to use, and the range of their 
intrinsic qualities which meet the s pecified requirements or expectations.
 
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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Quality control. The series of actions (analysis, inspections, etc.) to determine the quality 
of the raw materials or prescription medical devices for visual and ocular health. The 
definition also extends to the service/depar tment responsible for carrying out these 
activities.  
 Process control. Checks carried out during processing to ensure that a product and the 
process being used meet pre-determined specifications.
 
 
Approval decision. A decision taken on the basis of pre-established specifications, 
including a sampling plan, to use or not to use a raw material, product or material in general following its analysis.
 
 
Documentation. A series of requirements concerni ng the procedures and specifications 
for raw materials and the production of prescription medical devices for visual and ocular health, including information on their market performance. The definition also includes documents containing instructions for operations not necessarily linked to raw materials and the production of prescription medical devices for visual and ocular health, such as the handling, maintenance and cleaning of equipment, the testing and cleaning of plant and 
environmental control, sampling and inspection.
 
 
Distribution.  The dispatching of prescription medical devices for visual and ocular health 
to the various establishments in which they are to be marketed.  
 
Packing. A range of actions involving the packaging of finished products or their 
preparation for storage and/or distribution.  
 Packaging.  The container or item in direct contact with the prescription medical device for 
visual and ocular health.  
 
 
Raw material. Any substance involved in the production process and which forms part of 
the finished product in its original form or in an altered form, excluding packaging materials. 
 
  Processing.  Systematic use of a series of operations involving raw materials in order to 
obtain prescription medical devices for visual and ocular health.
 
 
Production. A series of actions necessary to obtain a prescription medical device for 
visual and ocular health.  
 
Finished product. A medical device which has gone through all stages of manufacture, 
also including its final container.  
 Correction.  The action of checking and reworking the figures for a specific mould used in 
the production of ophthalmic lenses to ensure it remains in accordance with the original base curve.       
 
 
Checking. An action making it possible to establish and prove that a process, procedure, 
instrument or item of equipment meets the requirements of its intended use or application.  
 
Zone. Part of a space or surface contained between certain limits, without the need for 
these to create a physical separation. 
 
 
III.  TECHNICAL AND SANITARY REQUIREMENTS FOR ESTABLISHMENTS WHICH 
MANUFACTURE, ADJUST, PROCESS, STORE, MARKET, DISTRIBUTE OR DISPENSE PRESCRIPTION MEDICAL DEVICES FOR VISUAL AND OCULAR 
HEALTH
 
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
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1. Human Resources 
  
In addition to complying with the requirements of the first and second paragraphs of Article 7 of Decree 2030/2007, the following requirements shall also be adhered to: 
 
a) Staff shall be given training to ensure that they have a full understanding of all 
procedures; however, they should not under any circumstances introduce changes 
without consulting their manager in charge. 
 
b) Staff at all levels shall understand their ro le and carry it out with the maximum possible 
dedication and skill. 
 c) Before being recruited and throughout their period of employment, all staff shall 
undergo medical examinations to ensure they are in a fit state of health, thereby avoiding any risk of contamination to the prescription medical devices for visual and 
ocular health at any stage of the process. 
 
 
d) Optometrists or ophthalmologists acting as scientific directors shall meet all legal 
requirements and hold a current employment contract. 
 
2. Organisation. 
 
a) The organisational structure shall be clearly defined. 
 
b) The establishment shall be adequately resourced with suitably qualified staff. 
 c) Managers responsible for manufacturing and those responsible for quality control shall 
be independent of one another. 
 
3. Hygiene and sanitation 
 
The establishment shall keep the environment, equipment, machines, instruments, raw 
materials, components, bulk materials and stocks of finished prescription medical devices 
for visual and ocular health in hygienic condition, well maintained, and in an orderly and clean state. Staff shall follow rules of good hygiene and comply with the company’s instructions on working practices, having regard to the occupational health programme.
 
 a) During manufacture and packaging, staff shall avoid direct hand contact with raw 
materials and prescription medical devices for visual and ocular health; any contact 
shall be properly justified. 
 b) In white areas, staff shall use protective gear such as gloves, caps, masks, aprons, 
overalls, shoes, overshoes, etc. which pr event cross contamination and the risk of 
increasing the contamination of production areas. 
 c) No plants, medicines or food and drink may be brought into or kept in production, 
laboratory, storage or other areas, and all activities which could have an adverse impact on the quality of products, such as smoki ng, drinking, eating or chewing, as well 
as the presence of animals, are prohibited. 
 
d) All establishments which manufacture, adjust, process, store, market, distribute or 
dispense prescription medical devices for visual and ocular health shall have a first-aid facility containing the items necessary to enable first aid to be administered and emergencies looked after. 
 
 e) The company shall develop a procedure- based cleaning and disinfection programme 
which shall include the keeping of records necessary to facilitate checking. RESOLUTION NO._________        OF 2008            PAGE No                                              6 
 
 
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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f) The hygiene and sanitation procedures described in this section shall be adhered to by 
establishments in respect of work done by “third parties” or where temporary staff are used, and audit systems shall be used to ensure compliance with the rules in force and those eventually amending or replacing them. 
 g) The establishment shall introduce a pest control programme based on written 
procedures, defining the frequency and timing for such programme, and maintain a 
register to record compliance with it; the programme shall set out clearly the measures to be taken to prevent contamination of premises and products. 
 
 h) The provisions of this Manual do not dis pense the establishment from the need to 
comply strictly with applicable regulations on  occupational health, industrial safety and 
environmental protection. 
 
 4.     Premises 
 
4.1 General rules for premises 
 
 
Ophthalmic laboratories, contact lens laboratories, optical workshops and opticians shops shall be located, designed, built, adapted and maintained in a manner appropriate for their purpose, thereby minimising risk and facilitating cleaning and maintenance, in order to 
avoid cross contamination, a build-up of dust and dirt and in general to avoid any condition 
detrimental to the quality of the prescription medical devices for visual and ocular health which are manufactured, adjusted, processed, stored, marketed or dispensed in them.   Ophthalmic laboratories, contact lens laboratories, optical workshops and opticians' shops shall have the following characteristics: 
  
4.1.1  Identification of working areas as follows:    
a) Reception, dispensing and administration: Black area  
b) Production and adjustment: White or grey areas  
c) Quality control: White or grey areas  
d) Storage and dispatch: Grey area  
 
White, grey and black areas are defined as such in order to enable precautions to be taken 
to avoid product contamination, with the white areas being the most strictly controlled in terms of the measures applied to reduce health risks.  4.1.2 Properly signed emergency evacuation routes, facilitating evacuation in case of 
need, and a sufficient number of fire extingui shers. Energy, lighting, ventilation, 
noise and drainage levels adequate for the operations being carried out, and which under no circumstances affect or interfere with their results.
 
 4.1.3 Permanent drinking water supply meeting the requirements of applicable health 
legislation. 
 
 4.1.4 The wastewater system shall be connected to the public sewerage network. Where 
the location of these establishments precludes connection to the public sewerage system, a system shall be installed for the treatment, evacuation and sanitary disposal of liquid waste, subject to prior approval of the competent environmental 
authority.
 
 
4.1.5 The necessary measures shall be taken to prevent the access of unauthorised 
persons to the controlled environment, production or quality control areas. Staff not employed in those areas may not use them as transit routes to other areas.
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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4.1.6 Drains shall be of an adequate size and be directly connected to the drainage 
system, with the necessary equipment to  prevent reflux. They shall also be 
protected, especially those located in the production areas. 
 4.1.7 Disposal of liquid waste: premises shall have drains for the evacuation of liquid 
waste designed and built in such a way as to enable it to flow swiftly, avoiding 
obstructions, and preventing the passage of gases, the loss or leakage of liquid, or 
the formation of deposits inside the tubing. There shall be no connection or interconnection with drinking water storage tanks and systems. To ensure adequate sanitary disposal of wastewater, ophthalmic laboratories, contact lens laboratories and optical workshops are required to hold the relative authorisations 
and permits issued by the competent environmental authority.
 
 
4.1.8 Disposal of solid waste: premises shall comply with applicable sanitary legislation, 
and in particular Decree 2676/2000 and Resolution 1164/2002, as well as other provisions supplementing, amending or repl acing them and issued by the Ministry 
of Social Welfare.
 
 4.1.9 All establishments shall have access to areas such as toilet facilities which shall be 
in sufficient numbers. Toilets are required to have toilet paper, washbasins and soap, hand-drying equipment (hot air or disposable paper towels) and a receptacle for waste. These areas shall be kept tidy, clean and well maintained.
 
 4.1.10 All establishments shall have an additional area for changing rooms.  4.1.11 Areas and zones used for processing, storage and quality control in ophthalmic 
lens laboratories, contact lens laboratories, ophthalmic prosthesis laboratories and optical workshops, as well as areas used for adjustments in ophthalmic lens 
laboratories and optical workshops shall meet the following requirements:  
 
 
a) Floors shall be waterproof, solid, strong, anti-slip, easy to clean and of a 
uniform surface smooth enough to prevent tripping and accidents. Floor levels shall be adequate for drainage purposes.
 
b) False ceilings, ceilings and walls shall be waterproof, fireproof, with smooth 
surfaces, solid and resistant to environmental factors such as humidity and temperature. Materials used for finishes shall not contain toxic, irritating or inflammable substances. They shall be covered with washable and easy to clean materials. The connection of walls with ceilings or false ceilings in 
environments required to be clean and germ-free shall be finished with curved 
coving.
 
c) Adequate natural or artificial light shall be provided. Bulbs or lamps in quality 
control, production and packing areas shall be protected to avoid accidents if breakages occur.
 
d) Premises shall be built in such a way as to facilitate cleaning of areas and 
equipment in accordance with the cleaning and disinfection programme, and 
shall have an adequate air supply for the type of area concerned. 
 
4.2 Specifications for areas and installations: 
 
4.2.1   Opticians shops 
 
For opticians’ shops to be opened and operated, the following areas are required as a minimum, in addition to their other requirements as commercial establishments:  
 
4.2.1.1 Grey area with the following zones:  
  
a) Area for the storage of prescription medical devices for visual and ocular health. RESOLUTION NO._________        OF 2008            PAGE No                                              8 
 
 
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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b) Quality control 
 
4.2.1.2 Black area with the following zones:  
 
a) Reception and administration b) Dispensing c) Cleaning equipment washing area: access is required to a sufficiently large area to 
store brushes, cloths, soap, detergent and other equipment for the same use.
 
  
 
4.2.2 Optical workshops or ophthalmic laboratories of low complexity, and ocular prosthesis laboratories.  
 
For optical workshops and ocular prosthesis laboratories to be opened and operated, the following areas are required as a minimum, in addition to their other requirements as commercial establishments:    4.2.2.1   Grey area with the following zones:  
 
a) Adjustment ( Applicable only to optical workshops) . This is an area to be used for 
bevelling, grooving, perforating, colouri ng, adding filters to, adjusting and soldering 
ophthalmic frames, and for the packing and fitting of ophthalmic lenses.
 
b) Processing ( Applicable only to ocular prosthesis laboratories) . This is an area to be 
used for the production and processing of ocular prostheses, prosthetic lenses, acrylic 
anophthalmic orbit conformers and expanders, photocured and thermocured resins.  
c) Quality control d) Storage e) Washing of equipment  
If an ocular prosthesis laboratory produces sterile ocular implants it shall include a 
sterilisation zone and meet the requirements for white areas. This sterilisation zone may be sourced externally.
 
 4.2.2.2 Black area with the following zones: 
   
a) Reception and administration b) Cleaning equipment washing area: sufficient space is required to store brushes, cloths, 
soap, detergent and other equipment for the same use.
 
 
 
4.2.3    Ophthalmic laboratories 
 
4.2.3.1 Ophthalmic laboratories of medium complexity  
 These are laboratories authorised to produce ophthalmic bases, ophthalmic lens shaping, 
finished lenses and the addition of ultraviolet and colour filters. For medium-complexity 
ophthalmic laboratories to be opened and operated, the following areas are required as a minimum, in addition to their other requirements as commercial establishments:   4.2.3.1.1 Grey area with the following zones: 
 
 
a) Processing. This is an area for the fixing, generation, cleaning and polishing of 
ophthalmic lenses (production and shaping of ophthalmic bases and shaping of ophthalmic lenses).
 
b) Adjustment. This is an area intended to be used for bevelling, grooving, perforating, 
colouring, adding filters to, adjusting and soldering ophthalmic frames, and for packing 
and fitting ophthalmic lenses (finished lenses and the addition of ultraviolet and colour 
filters).  RESOLUTION NO._________        OF 2008            PAGE No                                              9 
 
 
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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c) Storage 
d) Quality control 
e) Washing of equipment  4.2.3.1.2 Black area with the following zones: 
   
a) Reception and administration 
 
b) Cleaning equipment washing area: sufficient space is required to store brushes, cloths, 
soap, detergent and other equipment for the same use.
 
  4.2.3.2    Ophthalmic laboratories of high complexity   
 
These are laboratories authorised for activities of medium complexity and for the following additional activities: ophthalmic base production, finished lenses, hardened lenses, the addition of anti-reflection and anti-glare treatment, light sensitive materials, production of moulds for lens manufacture.
 
 
For high-complexity ophthalmic laboratories to be opened and operated, the following 
areas are required as a minimum, in addition to their other requirements as commercial establishments:   4.2.3.2.1 White area: 
 
Processing. For procedures involving anti-glare lenses, anti-reflection film, the use of light-sensitive material and the production of moulds for lens manufacture, a controlled environment is required for up to 3,500,000 particles per square metre. The airflow direction shall never run from an unclean area to a clean area.  The white area shall have an airtight compartment for the handling and location of the specialist equipment for these 
areas.  
 
 
4.2.3.2.2 Grey area with the following zones:  a) Processing. This is an area for the fixing, generation, cleaning and polishing of 
ophthalmic lenses. This zone shall be separate from the one used for processing anti-glare 
lenses and procedures for anti-reflection films as specified for the white area.   b) Adjustment. This is an area intended to be used for bevelling, grooving, perforating, 
colouring, adding filters to, adjusting and soldering frames, packing and labelling, and for 
fitting ophthalmic lenses. 
 
 c) Storage  d) Quality control. 
 
e) Washing equipment  4.2.3.2.3 Black area with the following zones:    
a) Reception and administration 
 b) Cleaning equipment washing area: sufficient space is required to store brushes, cloths, soap, detergent and other equipment for the same use.
 
 4.2.4  Contact lens laboratories  
 RESOLUTION NO._________        OF 2008            PAGE No                                              10 
 
 
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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For contact lens laboratories to be opened and operated, the following areas are required 
as a minimum, in addition to their other requirements as commercial establishments:  
 4.2.4.1 4.2.4.1 Black area with the following zones:    a) Processing. For the production and hydration of soft contact lenses, a controlled environment of up to 3,500 particles per cubic metre is required. 
  
b) Sterilisation of soft lenses  b) Packing of soft lenses  
d) Quality control of soft lenses: This ar ea shall meet the following additional requirements:
 
 
1) Control of the contaminant load such as viruses, bacteria, fungi and suspended particles. 2) Air filtered through high-efficiency particulate air filters, with appropriate pressure differences between areas, which are to be documented. 
 
3) A documented system to supervise temperature, humidity, air supply, numbers of particles and colony forming units. 
 
4) Excessive heat, vapour condensation and dust shall be avoided and there shall be a system to remove contaminated air. 5) The airflow direction shall never run from an unclean area to a clean area.  
 
4.2.4.2 Grey area with the following zones:  a) Processing and packing of rigid lenses. This is an area for turning, moulding, shaping, cutting, polishing and packing rigid contact lenses (in their dry state).
 
b) Packaging 
c) Storage 
d) Quality control of rigid lenses e) Washing equipment  4.2.4.3 Black area with the following zones: 
 
a) Reception and administration b) Washing of cleaning equipment and cleaning ar ea: sufficient space is required to store 
brushes, cloths, soap, detergent and other equipment for the same use.
 
 
 
5.      Equipment, accessories, tools, machinery and instruments 
 
5.1  General comments 
 
a) Equipment, accessories, tools, machinery and instruments shall be of a quality 
appropriate to their intended use. 
b) Equipment, accessories, tools, machinery and instruments coming into contact with 
ophthalmic lens and contact lens materials shall be constructed in such a way that their surfaces do not affect the safety and quality of such lenses. 
 
c) Equipment shall not represent a risk to ophthalmic and contact lenses, or in 
general to any products. 
d) Parts of the equipment coming into contact with ophthalmic and contact lenses 
shall not be reactive, additive or absorbent to an extent that could affect the quality of those lenses.  
 
e) Parts of the equipment coming into contact with ophthalmic lenses, contact lenses 
and ocular prostheses, shall have sanitary  characteristics permitting easy cleaning, 
and shall not have cracks or irregularities liable to harbour remnants of materials RESOLUTION NO._________        OF 2008            PAGE No                                              11 
 
 
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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used in the manufacturing process and producing microbial contamination of any 
other type. 
f) Machinery and equipment shall be installed in areas in such a way that the 
passage of staff and materials is possible, with the risk of confusion or contamination reduced to a minimum. 
g) All equipment or machinery shall be covered by programmes of periodic 
maintenance and operational checks to ensure that it is fit for its intended purpose. 
h) Measurement equipment and instruments shall be calibrated periodically. 
i) Equipment cleaning and maintenance records shall be kept under lock and key and 
signed by those responsible. They form part of the official documentation. 
j) Where equipment produces excessive noise or heat, the necessary preventive 
measures shall be taken to avoid damage to the health of operators. 
k) Defective or disused equipment shall be withdrawn from the processing areas or at 
least clearly identified as “not in use”. 
l) The establishment shall have the equipment, machinery and instruments needed to 
carry out all activities properly and guarantee continuity of operation in the event of any dysfunction. 
m) Machinery and equipment in white areas shall, in addition to the procedures 
detailed above, be disinfected and sterilised in accordance with a validated and 
documented procedure. 
 
5.2 Special equipment 
  5.2.1 Opticians’ shops without consulting rooms shall have the following equipment as a 
minimum: 
 
  
a) Powder heater or burner b) Screwdriver, pincers, spanners c) Spherometer 
d) Shelves, display units or hooks 
e) Ultraviolet lamp f) Lensometer g) A UV transmittance or absorbance meter h) Millimetric rulers 
 
5.2.2 Optical workshops shall be equipped with the following, in addition to the equipment detailed in point 5.2.1:   
a) Edging machine 
b) Tinting machine 
c) Welder d) Drill e) Slitter f) Die-cutters or moto tools 
 
5.2.3 Ophthalmic lens laboratories of medi um complexity shall be equipped with the 
following, in addition to the equipment detailed in points 5.2.1 and 5.2.2:   
a) Protective film applicators b) Blockers and plates 
c) Calibrator or thickness measurement equipment 
d) Generators e) Cylindrical cleaning and/or polishing machines f) Hardening machine (if applicable) g) Moulds h) Rectifiers 
 RESOLUTION NO._________        OF 2008            PAGE No                                              12 
 
 
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ocular health ” 
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If the medium-complexity ophthalmic lens labor atory makes high-index lenses, it also 
requires hardening equipment. 
 If the medium-complexity ophthalmic lens laboratory does not carry out rectification on its own premises, an outsourcing contract for this is required.  5.2.4 High-complexity ophthalmic lens laboratories shall be equipped with the following, in 
addition to the equipment detailed in points 5.2.1, 5.2.2 and 5.2.3:  
 
a) Air filtration system b) Anti-reflection machine 
                         
If the high-complexity ophthalmic lens laboratory does not carry out rectification on its own 
premises, an outsourcing contract for this is required.  If the laboratory does not have an anti-reflection machine, an outsourcing contract for this is required.  
5.2.5 Contact lens laboratories shall have the following equipment as a minimum: 
 
  
a) A centraliser if a handler is used b) Diameter measure or ruler c) Stereoscope or screen projector 
d) Lensometer 
e) Magnifying glasses for comparisons f) Edging machine or edger, or lens finishing equipment g) Microscope h) Finishing and cleaning moulds i) Handler or clamping plate 
j) Surface polisher 
k) Radioscope l) Radial, tangential or diametral lathe m) Thickness calibrator 
 
5.2.6 Laboratories producing soft compact lenses shall have the equipment listed in point 
5.2.5 plus the following:  
a) Magnetic shaker b) Steriliser 
c) Laminar flow cabin 
d) Hydration, inspection, sterilisation, packing and packaging systems e) Sealing machine or stapler 
 5.2.7 Ocular prosthesis laboratories shall have the following equipment as a minimum: 
 
  
a) Centrifuge or lathe (depending on the process used) 
b) Moto-tool equipment c) Photocuring unit or thermocuring equipment d) Injectors e) Polishing machine 
f) Moulds 
g) Adjustable speed motor for cleaning and grinding h) Pulleys i) Pincers 
 If wax is used in the preparation of moulds, torches or lighters shall also be available. 
 
  
6.     Maintenance and services RESOLUTION NO._________        OF 2008            PAGE No                                              13 
 
 
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manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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6.1  Each item of equipment and instrument shall be covered by a system of preventive 
maintenance to ensure it operates reliably and without risk either to the operator or to the quality and safety of the prescription medical device for visual and ocular health. For that purpose, a programme of checks, calibration and preventive maintenance of all equipment shall exist and be duly documented and recorded. 
 
6.2  One person shall be given overall responsibility for the maintenance and calibration 
of equipment and instruments; there may also be a maintenance department.  
 6.3  The maintenance department may be in-house or sourced externally, in which case 
an appropriate contract shall be entered into. This service shall take the following 
points into account: 
 
 
a) An updated manual containing written instructions for the preventive maintenance 
of all machinery or equipment, and of the premises used by the various departments. 
b) These instructions shall cover the method, frequency, recording procedures, etc. 
of the maintenance work and any adjustments made to the machinery or 
equipment. 
 
 6.4  Maintenance of the sources of the different types of water, electricity and gas shall 
be carried out appropriately to ensure that the necessary quality is being obtained for 
the use made of each one, and to prevent accidents to or deterioration of premises 
or equipment.  
 6.5  Compressed air, whether or not centrally produced, shall be used under permanent 
surveillance to ensure there is no contami nation from physical or microbe particles 
above permitted levels, if applicable.  
 
6.6  The maintenance department shall take responsibility for the control of waste, 
residues and scrap.  
 
 
7.      Storage and distribution.  
7.1 Storage areas shall be sufficiently large for their intended purpose and be kept clean 
and tidy.  
 
7.2 Where special storage conditions are necessary, such as temperature and humidity, 
these shall be laid down in the written procedures and be checked and recorded. 
 
 7.3 All materials arriving in the storage areas shall be identified and placed in appropriate 
containers ensuring they are protected and that no contamination occurs.  
 
7.4 Quarantine areas and areas for approved materials shall be available. All materials 
rejected by quality control shall be identified visibly as such pending destruction.
 
 7.5 All supplies and products shall be stored in accordance with their particular quality 
requirements, and be clearly identified, ti dy and stored separately; access to these 
areas shall be restricted. 
 7.6 All materials and raw materials in storage shall be kept on storage units and/or 
shelving, avoiding contact with the ground. 
 7.7 Written procedures shall exist in the following areas: 
 RESOLUTION NO._________        OF 2008            PAGE No                                              14 
 
 
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a) General procedure for the receipt, approval or rejection, storage, sampling and 
dispatch of materials. 
b) Procedures for the storage of raw materials, components and supplies. c) Procedures for the storage of semi-finished and finished products. All procedures 
shall set out clearly all storage conditions and any special warnings required for specific materials.
 
d) Written procedures shall exist setting out the distribution methods for products. 
 
8. Handling of supplies 
8.1  All supplies, raw materials and other materials received by establishments covered 
by this resolution and which are to be used in the course of processing, adjustment, storage or dispensation as applicable, shall be subjected to testing before use, 
immediately after receipt or processing, until their use has been authorised in 
accordance with established procedures. 
8.2  The purchase of raw materials and supplies is an important process which shall be 
handled by staff with knowledge of the products and their suppliers. Raw materials and supplies received by the establishments to which this resolution relates and which are used in the processing and adjustment of prescription medical devices for 
visual and ocular health shall be checked with reference to the following factors: 
 
  
a) Name given to the product and, where applicable, its reference code. b) Batch number(s) allocated by the manufacturer. c) Date received by the establishment. 
d) Condition of products or materials in quarantine, on test, approved, rejected, 
returned or withdrawn.  
e) Where applicable, the expiry date or date beyond which a further test is 
necessary. 
f) Identity of the supplier. g) Name and address of the manufacturer. 
 
h) Health register (where applicable). i) If no health register is required, the respective analysis certificates. 
  8.3 Only supplies authorised by the Head of Quality and which are still within their shelf life 
may be used. Written procedures shall exist for handling supplies. 
 
9. Packaging.  
 
9.1  The acquisition, handling and control of the raw materials for packing and printed 
packaging materials shall be carried out in the same way as for raw materials.  
9.2 Containers, packaging and labels shall be stored in secure conditions in order to 
prevent unauthorised persons from gaining access to them. Packing and packaging materials shall be issued only to designated individuals on the basis of a written and approved procedure. 
 
9.3  All out-of-date or obsolete packaging or labelling materials shall be destroyed and a 
record kept of the method of disposal. 
9.4  All stages of the packing and packaging process shall be carried out in accordance 
with written instructions in order to ensure uniform quality in line with the specifications applicable. 
 
 10.  Quality management 
 
10.1 General principles 
 
This term refers to the range of measures taken to ensure that all prescription medical 
devices for visual and ocular health are of high quality and are safe. Management of the 
establishment is responsible for the quality and safety of the prescription medical devices RESOLUTION NO._________        OF 2008            PAGE No                                              15 
 
 
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for visual and ocular health, and shall ensure that they are fit for use, are suitable for 
authorisation and do not constitute an additional risk for the user.  
 
Establishments shall devise, document, introduce and maintain a quality and continuous 
improvement system.  
 
The quality management system shall guarantee the following points:  a) That the quality system is staffed with people properly trained to carry out and 
coordinate all the necessary controls. 
b) That the prescription medical devices for visual and ocular health are manufactured, 
processed, adjusted, stored, marketed, distributed and/or dispensed in a manner which complies with the requirements of this resolution and its technical annex. 
 
c) That the manufacture, processing, adjusting, analysis, storage, distribution and/or 
dispensing are clearly specified in writing and that the requirements of this resolution and its technical annex are adopted. 
 
d) That the responsibilities of the manager s and staff involved are clearly defined. 
e) That all necessary controls are carried out on all supplies, raw materials, products, 
calibrations and tests during the processing of these devices. 
f) That the prescription medical devices for visual and ocular health are not issued before 
the responsible persons have certified that they have been released in accordance 
with applicable requirements.   
g) That quality audit procedures are set up to evaluate regularly the effectiveness and 
applicability of the entire quality management system.  
h) The quality system is required to examine and comment on products returned, 
deciding on whether they can be rectified or are to be destroyed . 
 
11. Quality control 
  
a) The establishment shall carry out quality control activities and, if necessary, may avail 
itself of a specialist external body to carry out the analyses concerned. 
 b) Quality controls shall be undertaken on manufacturing, processing, adjustment, 
storage and distribution. 
 
 
c) Raw materials, semi-finished products and finished products shall comply with the 
manufacturer’s specifications.  
 
d) Quality control activity shall be based on an up-to-date procedures manual.  
e) The results of all quality controls and procedures shall be recorded. 
 f) The appropriate equipment, instruments and supplies shall be available for the 
purpose of carrying out quality control activity. 
 
Documentation and files. 
 
a) Establishments manufacturing and marketing prescription medical devices for visual 
and ocular health shall ensure that a system of documentation is maintained for each process carried out. 
 
 b) Those establishments are required to maintain a register of actions undertaken in such 
a way that all activities related to the processing, adjustment, storage and dispensing RESOLUTION NO._________        OF 2008            PAGE No                                              16 
 
 
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of these devices are recorded. Registers shall be held and kept available for the period 
established in Article 25 of Law 594/2000.  
 
c) Information may be recorded using electronic data processing systems, photographic 
systems or other appropriate methods.  
 
d) The establishment shall determine its procedur es on the basis of its type of production 
and of its organisational structure, and shall describe in detail the operations, precautions and measures to be adopted in the various activities. 
 
 
 COMPLAINTS 
 
 a) Procedures shall exist for the receipt, handling and closure of complaints. b) The establishment shall have the necessary mechanisms to deal with the complaint 
and respond to the user or interested party. 
 
c) If the prescription medical devices for visual and ocular health give rise to an incident 
or occurrence which results in unintentional harm to the patient, the operator or the environment, this shall be reported to the health authority. 
d) One person shall be designated with responsibility for receiving, investigating and 
responding to complaints. 
e) Every complaint shall give rise to an investigation, which shall be duly documented. 
f) A complaints file shall be maintained; an appropriate register shall be kept to record 
complaints received by telephone. 
 
g) Periodic checks shall be carried out on complaints received in order to identify trends 
and develop improvements in processes.  
 
    
 
     
 
    
 
    
 
     
 
   RESOLUTION NO._________        OF 2008            PAGE No                                              17 
 
 
Continuation of the Resolution “ Establishing the technical and sanitary  requirements for establishments which 
manufacture, process, adjust, store, market, distribute or dispense prescription medical devices for visual and 
ocular health ” 
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TECHNICAL ANNEX No 2 
     
LIST OF PRESCRIPTION MEDICAL DEVICES FOR VISUAL AND OCULAR HEALTH. 
  Prescription corrective or neutral lenses regardless of material, treatment, design or filter 
used.  
 
Prescription frames. Prescription contact lenses, regardless of material, design, colour and methods of use, 
and whether corrective, neutral, therapeutic or cosmetic. 
Prescription orbital implants, ocular prostheses and other prosthetic accessories.  
Prescription stenopaeic eyeglasses. 
Optical and non-optical aids for limited vision: eyepieces, monocles, magnifying glasses or 
lenses and dioptric lenses.
 
Devices for treating orthoptic and pleoptic problems: stereograms requiring dioptric 
matching and lens filters with colouring on a specific wavelength.  
All prescription medical devices for visual and ocular health which may in the future 
become used for ophthalmic purposes as a result of scientific and technological  advances, as well as other devices as defined by Invima (National Institute for Food and Drug Monitoring).