REPUBLIC OF COLOMBIA  
 
G/TBT/N/COL/108/Add.2  
 
 
MINISTRY OF SOCIAL WELFARE  
 
 
RESOLUTION NO. 0043 96 OF 2008  
 
Adopting the Manual of technical and sanitary requirements for establishments which 
manufacture  and place on the market prescription medical devices for visual and ocular 
health  
 
 
THE MINISTER OF SOCIAL WELFARE  
 
 
Acting within powers conferred by law, and in parti cular those conferred by Decree  
205/2003 and Article 4 of Decree 1030/2007 and  
 
 
 WHEREAS:  
 
 
Prescription medical devices are not included wi thin the scope of Decree 4725 of 2005 
on the control and monitoring of medical devices for human use.  
 
It is necessary to monitor the quality of prescription medical devices, especially those 
related to visual and ocular health, and to that end it is essen tial to define the technical 
health conditions for their manufacture, processing, adjustment, storage, marketing, 
distribution and dispensation.  
 
Article 4 of Chapter II of Decree 1030 of 2007 provides that the Ministry of Social 
Welfare must  set the techn ical sanitary requirements for establishments which 
manufacture and market prescription medical devices for visual and ocular health.  
 
By virtue of the foregoing, this Ministry,  
 
 
ORDERS AS FOLLOWS:  
 
 
ARTICLE 1. To adopt the Manual of technical and sanitar y requirements for 
establishments which manufacture  and place on the market prescription medical 
devices for visual and ocular health, as set  out in Technical Annex N o. 1, which forms  
an integral part of this  Resolution.  
 
ARTICLE 2. This Resolution enters into force on the date of its publication and  revokes 
any provisions conflicting with it . 
 
 
TO BE PUBLISHED AND COMPLIED WITH  
  
Done at Bogotá D.C. on 12 November 2008.  
 
 
 
 
DIEGO PALACIO BETANCOURT  
Ministry of Social Welfare  
 
 
 
 
 
Drafted by:  Claudia Isabe l Guevara  
Reviewed by:  Rosabel Rubitano  
  Edgar E. Bernal  
  Gisela Rivera  
  Nidia Piruto  
 
 
Official Gazette No. 47.177 of 12 November 2008  
 
 
 TECHNICAL ANNEX No 1  
 
 
MANUAL OF TECHNICAL AND SANITARY REQUIREMENTS FOR  
ESTABLISHMENTS  WHICH MANUFACTURE  AND PL ACE ON THE MARKET 
PRESCRIPTION MEDICAL DEVICES FOR VISUAL AND OCULAR HEALTH  
 
 
I. PURPOSE  
 
The purpose of this manual is to regulate  the technical and sanitary requirements  for 
establishments which manufacture, adjust, process,  store, market, distribute or 
dispense  prescription medical devices for visual and ocular health  pursuant to the 
provisions of Article 1 of Decree 1030 of 2007.  
 
II. DEFINITIONS  
 
For the purposes of this Manual, the definitions given in  Article 2 of  Decree 1030/2007  
must  be used,  as we ll 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.  
 
Approval  criterion . Judgement based on pre -established specifications, including a 
sampling plan, determining whether or not an analysed  raw material, product or 
material in general may be used . 
 
Approved. The condition of a raw material or product, or of any mate rial in general 
which guarantees that it is ready for use.  
 
Area. A physically separate space contained within  certain limits.  
 
Black area: A physically separate space in which control of the contaminant load, the 
lighting conditions and air supply is not guaranteed. Access is not restricted.  
 
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.  
 
Controlled environment. A location o r space controlled as regards both viable and 
nonviable particles. Temperature and humidity  should also be controlled . 
 
Correction. The action of checking and reworking the figures for a specific mould used 
in the production of ophthalmic lenses to ensure it retains the original base curve.  
 
Distribution. The dispatching of prescription medical devices for visual and ocular 
health to the various establishments in which they are to be marketed.  
 
Documentation. A se t of requirements concerning 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 neces sarily 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 inspectio n. 
 
Environment. The physical conditions or situation of a  single  location.  
 
Finished product. A medical device which has gone through all stages of 
manufacture, also including its final container.  
 
Grey area: A physically separate space in which control o f the contaminant load, the 
lighting conditions and air supply is not guaranteed. Access is semi -restricted.  
 
Packag e. The container or item in direct contact with the prescription medical device 
for visual and ocular health.  
 
Packing. A range of actions i nvolving the packaging of finished products or their 
preparation for storage and/or distribution.  
 
Process control. Checks carried out during processing to ensure that a product and 
the process being used meet pre -determined specifications.  
 
Processing. Systematic use of a series of operations involving raw materials in order 
to produce  prescription medical devices for visual and ocular health.  
 
Production. A series of actions necessary to produce  a prescription medical device for 
visual and ocular health.  
 
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.  
 
Quality control. The serie s of actions (analysis, inspections, etc.) to determine the 
quality of raw materials or prescription medical devices for visual and ocular health. 
The definition also extends to the service/department responsible for carrying out these 
activities.  
 
Quality . A set  of properties of raw materials or prescription medical devices for visual 
and ocular health which determine  they are effective and safe to use, and all the 
intrinsic qualities which must meet specified requirements or expectations.  
 
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.  
 
Storage. The activity whereby  prescription medical devices for visual and ocular  health  
and raw materials are kept in conditions which assure that they will not be subject to 
any disturbances or changes that could affect  the quality of the products  
 
Technical audit. A systematic, independent and documented process to obtain 
evidence o n an audit and to assess it objectively with a view to determining the extent 
to which audit criteria are being complied with.  
 
White area: A physically separate space in which control of the contaminant load, such 
as viruses, bacteria, fungi and suspended partic les, is guaranteed. These areas have 
controlled lighting and air supply. Access is restricted.  
 Zone. Part of a space or surface contained within  certain limits, which need not be 
physical ly separat ed. 
 
 
III. TECHNICAL AND SANITARY REQUIREMENTS FOR ESTABLI SHMENTS  
 
 
1. Human Resources  
 
Pursuant to Article 7 of Decree 1030 of 2007, the following requirements must be met : 
 
a) Staff must  be given training to ensure that they have a full understanding of all  
procedures; however, they should not under any circumstan ces introduce 
changes  without consulting their superiors  in charge.  
b) Staff at all levels must  understand their role and carry it out with the maximum 
possible  dedication and skill.  
c) Before being recruited and throughout their period of employment, all staff  
involved in the manufacture of ophthalmic or contact lenses and who directly 
handle the different elements,  must  undergo medical examinations to ensure 
they are in a fit state of health, thereby  avoiding any risk of contamination to the 
prescription medica l devices for visual and  ocular health at any stage of the 
process.  
d) Optometrists or ophthalmologists acting as scientific directors must  meet all 
legal  requirements and hold a current employment contract  or prove some sort 
of contractual link . 
 
2. Organisa tion.  
 
a) The organisational structure must  be clearly defined.  
b) The establishment must  be adequately resourced and employ  suitably qualified 
staff.  
c) The persons in charge of manufacturing and quality control must be mutually 
independent.  
 
3. Sanitation and h ygiene  
 
The establishment must  keep the environment, equipment, machines, instruments, raw  
materials, components, bulk materials and stocks of finished prescription medical 
devices  for visual and ocular health in good conditions of hygien e, repair , order an d 
clean liness . Staff must  follow rules of good hygiene and comply with the company’s  
instructions on working practices, with due  regard for the occupational health 
programme.  
 
a) During manufacture and packaging, staff must  avoid direct hand contact with 
raw materials and prescription medical devices for visual and ocular health; any 
contact  must  be properly justified.  
b) In white areas, staff must  use protective gear such as gloves, caps, masks, 
aprons,  overalls, shoes, overshoes, etc. which prevent cross contam ination 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 qua lity of products, su ch as smoking, drinking or 
eating , 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 healt h must  have a first -aid facility containing the items necessary to administer first aid and  deal 
with emergencies.  
e) The company must  develop a procedure -based cleaning and disinfection 
programme  which must  include the keeping of records necessary to facilit ate 
checking.  
f) The hygiene and sanitation procedures described in this section must  be 
adhered to by  establishments in respect of work done by “third parties” or where 
temporary staff are  used, and audit systems must  be used to ensure 
compliance with the ru les in force and  any that may supplement,  amend or 
replac e them.  
g) The establishment must  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 must  set out 
clearly the measures  to be taken to prevent contamination of premises and 
products.  
h) The provisions of this Manual do not dispense 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  must  be located, designed, built, adapted and maintained in a m anner 
appropriate to their  purpose, thereby minimising risk and facilitating cleaning and 
maintenance, in order to  avoid cross contamination, the 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 therein . 
 
Ophthalmic laboratories, contact lens laboratories, optical workshops and opticians' 
shops  must  have the following characteri stics:  
 
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 ; white areas are the most strictly controlled in  
terms of the measures applied to reduce health risks.  
 
4.1.2 Properly signed emergency evacuation routes, facili tating evacuation in case of  
need, and a sufficient number of fire extinguishers. Energy, lighting, ventilation,  noise 
and drainage levels adequate for the operations being carried out, and which  under no 
circumstances affect or interfere with their result s. 
 
4.1.3 Permanent drinking water supply meeting the requirements of applicable health  
legislation.  
 
4.1.4 The wastewater system must  be connected to the public sewerage network. 
Where  the location of these establishments precludes connection to the publi c sewerage  system, a system must  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 must  be taken to prevent access of unauthor ised 
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.  
 
4.1.6 Drains must  be of an adequate size and be directly connected to the drainage  
system , with the necessary equipment to prevent reflux. They must  also be  protected, 
especially those located in the production areas.  
 
4.1.7 Disposal of liquid waste: premises must  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 and formation of vacuums,  leakage 
or the formation of deposits inside the tubing. There must  be no connection or  
interconnection with drinking water storage tanks a nd systems. To ensure  adequate 
sanitary disposal of wastewater, ophthalmic laboratories, contact lens  laboratories and 
optical workshops are required to hold the corresponding  authorisations  and permits 
issued by the competent environmental authority  in ac cordance with the provisions of 
Article 31 of Law 99 of 1993 and any that may supplement,  amend or replac e them . 
 
4.1.8 Disposal of solid waste: premises must  comply with applicable sanitary 
legislation,  and in particular Decree 2676/2000  as amended by Dec rees 1669 of 2002 
and 4126 of 2005,  Resolution 1164/2002, and any other  provisions that may be  issued 
by the Ministry of Social Welfare  to supplement, amend or replac e them.  
 
4.1.9 All establishments must  have access to areas such as toilet facilities , which must  
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 must  be kept tidy, clean and well maintained.  
 
4.1.10 All e stablishments must  have an additional area for changing rooms.  
 
4.1.11 White a reas used for processing  and quality control in ophthalmic  lens 
laboratories, contact lens laboratories, ocular  prosthesis laboratories and  optical 
workshops, as well as areas us ed for adjustments in ophthalmic lens  laboratories and 
optical workshops , must  meet the following requirements:  
 
a) Floors must  be waterproof, solid, strong, anti -slip, easy to clean and of a  
uniform surface smooth enough to prevent tripping and accidents. Fl oor 
levelling must  be adequate for drainage purposes.  
b) False ceilings, ceilings and walls must  be waterproof, fireproof, with smooth  
surfaces, solid and resistant to environmental factors such as dampness  and  
temperature. Finishing m aterials used must  not c ontain toxic, irritating or  
inflammable substances. Surfaces must be coated  with washable and easy to  
clean materials. In areas requiring sterilisation, all wall -ceiling or false ceiling 
joints must be finished with half -round moulding.  
c) Adequate natural or  artificial light must  be provided. Bulbs or lamps in quality  
control, production and packing areas must  be protected to avoid accidents if  
breakages occur.  
d) Premises must  be built in such a way as to facilitate cleaning of areas and  
equipment in accordance  with the cleaning and disinfection programme, and  
must  have an adequate air supply for the type of area concerned.  
 4.2 Specifications for areas and premises : 
 
4.2.1 Opticians ' shops  
 
For purposes of opening and operating an optician ’s shop, at least the following areas 
are required in addition to the requirements it must satisfy as a commercial 
establishment:  
 
4.2.1.1 Grey area with the following zones:  
 
a) Zone  for the storage  and dispens ing of prescription medical devices for visual 
and ocular health.  
b) Qual ity control  zone.  
 
4.2.1.2 Black area with the following zones:  
 
a) Reception and administration  zone.  
b) Dispensing  zone.  
c) Cleaning equipment washing area: access is required to a sufficiently large  area 
to store brooms , floor cloths, soap, detergent and other e quipment for the same 
use. 
 
4.2.2 Optical workshops or ophthalmic laboratories of low complexity, and ocular  
prosthesis laboratories.  
 
For purposes of opening and operating an optical workshop or ocular prosthesis 
laborator y, at least the following areas a re required in addition to the requirements it 
must satisfy as a commercial establishment:  
 
4.2.2.1 Grey area with the following zones:  
 
a) Adjustment ( Applicable only to optical workshops) . This is a zone  to be used for  
bevelling, grooving, perforating, colo uring, adding filters, 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 p rostheses,  prosthetic 
shells, acrylic  anophthalmic orbit conformers and expanders, and photocured 
and thermocured resins.  
c) Quality control  
d) Storage  
e) Washing of equipment  
 
If an ocular prosthesis laboratory produces sterile ocular implants it must  include a  
sterilisation zone and meet the requirements for white  or sterile  areas. This sterilisation 
zone may  be sourced externally.  
 
4.2.2.2 Black area with the following zones:  
 
a) Reception and administration  zone.  
b) Cleaning equipment washing area: sufficient space is  required to store brooms, 
floor 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 l ens 
shaping,  finished lenses and the addition of ultraviolet and colour filters. For purposes 
of opening and operating a medium -complexity  ophthalmic laborator y, at least the 
following areas are required in addition to the requirements it must satisfy as a 
commercial establishment:  
 
4.2.3.1.1 Grey area with the following zones:  
 
a) Processing. This is a zone  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 a zone  intended to be used for bevelling, grooving, 
perforating,  colouring, adding filters, adjusting and soldering ophthalmic frames, 
and for packing  and fitting ophthalmic lenses (finished lenses and the addition 
of ultraviolet and colou r filters).  
c) Storage  
d) Quality control  
e) Washing of equipment  
 
4.2.3.1.2 Black area with the following zones:  
 
a) Reception and administration  zone.  
b) Cleaning equipment washing area: sufficient space is required to store brooms, 
floor cloths, soap, detergent and ot her 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: production of ophthalmic base s, finished lenses, 
hardene d lenses, the  addition of anti -glare  and scratch -resistance  treatment, light 
sensitive materials, production of  moulds for lens manufacture.  
 
For purposes of opening and operating a high-complexity ophthalmic laborator y, at 
least the following  areas are re quired in addition to the requirements it must satisfy as a 
commercial  establishment:  
 
4.2.3.2.1 White area:  
 
Processing. For procedures involving anti -glare coating , 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 must  
never run from an unclean area to a clean area. The white area must  have  an airtight 
compartment for the handling and location of the specialist e quipment 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  and procedures for scratch -resistant lenses . This zone must  
be separate from the o ne used for processing anti -glare coatings as specified 
for the white area.  
b) Adjustment. This is an area intended to be used for bevelling, grooving, 
perforating,  colouring, adding filters, adjusting and soldering frames, labelling, 
and for  fitting ophthalm ic lenses.  
c) Storage  d) Quality control.  
e) Washing equipment  
 
4.2.3.2.3 Black area with the following zones:  
 
a) Reception and administration  zone.  
b) Cleaning equipment washing area: sufficient space is required to store brooms, 
floor cloths, soap, detergent and other  equipment for the same use.  
 
4.2.4 Contact lens laboratories  
 
For purposes of opening and operating a contact lens laborator y, at least the following 
areas are required  in addition to the requirements it must satisfy as a commercial 
establishment:  
 
4.2.4. 1 White  area with the following zones:  
 
a) Processing. For the hydration of soft contact lenses, a controlled  environment of 
up to 3,500 particles per cubic metre is required.  The manufacturing process in 
controlled environment areas is included for centrifug ed soft lenses.  
b) Sterilisation of soft lenses . 
c) Sterilised p acking of soft lenses  requiring USP -quality sterilised water.  
d) Quality control of soft lenses: This area must  meet the following additional 
requirements:  
 
1) Control of the contaminant load such as bact eria, 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, number o f 
particles and colony forming units.  
4) Excessive heat, vapour condensation and dust must  be avoided and there must  
be a system to remove contaminated air.  
5) The airflow direction must  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 hard lenses. This is an area for turning, moulding, 
shaping,  cutting, polishing and packing hard contact lenses (in their dry state).  
b) Packaging  
c) Storage  
d) Quality control of hard lenses  
e) Washing equipment  
 
4.2.4.3 B lack area with the following zones:  
 
a) Reception and administration  zone.  
b) Washing of cleaning equipment and cleaning area: sufficient space is required 
to store brooms, floor cloths, soap, detergent and other equipment for the same 
use. 
 
 
OBSERVATION  
 Nation ally or internationally accepted  standards may be used for manufacturing and 
processing at different establishments  such as, inter alia, NTC, ISO and CEN, or 
processes may be set up in such a way as to  comply with the safety and operational 
conditions for prescription medical devices for visual and ocular health stipulated in 
Article 30 of Decree 1030 of 2007 or any regulation s that may amend , supplement or 
replac e the latter . 
 
 
5. Equipment, accessories, tools, machinery and instruments  
 
5.1 General commen ts 
 
a) Equipment, accessories, tools, machinery and instruments must  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 must  be constr ucted in such a 
way that  their surfaces do not affect the safety and quality of such lenses.  
c) Equipment must  not represent a  quality or safety  risk to ophthalmic and contact 
lenses, or in  general to any  of the products manufactured and/or adjusted.  
d) Parts of  the equipment coming into contact with ophthalmic and contact lenses  
must  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, must  have sanitary characteristics permitting 
easy cleaning,  and must  not have cracks or irregularities liable to harbour 
remnants of materials  used in the manufacturing process and producing 
microbial contamination o r contamination of any other sort.  
f) Machinery and equipment must  be installed in areas in such a way that the  
passage of staff and materials is possible, with  minimal  risk of confusion or  
contamination.  
g) All equipment or machinery must  be covered by programmes  of periodic  
maintenance and operational checks to ensure that it is fit for its intended 
purpose.  
h) Measur ing equipment and instruments must  be calibrated periodically.  
i) Equipment cleaning and maintenance records must  be dated and signed by 
those responsible  and form part  of the official documentation.  
j) Where equipment produces excessive noise or heat, the necessary preventive  
measures must  be taken to avoid damage to the health of operators.  
k) Defective or disused equipment must  be withdrawn from the processing areas 
or at least clearly identified as “not in use”.  
l) The establishment must  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 whit e areas  processing contact or intra -ocular 
lenses  must , 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 must  have at least the following equipment:  
 
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 must  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 medium complexity must  be equipped with the  
following, in addition t o the equipment detailed in points 5.2.1 and 5.2.2  with the 
exception of shelves, display units and hooks : 
 
a) Protective coating applicators  
b) Blockers and plates  
c) Calibrator or thickness measur ing equipment  
d) Generators  
e) Cylindrical cleaning and/or polishing mach ines 
f) Hardening machine (if applicable)  
g) Moulds  
h) Rectifiers  
 
If a medium -complexity ophthalmic lens laboratory makes high -index lenses, it also  
requires hardening equipment.   
 
If a 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 must  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-glare  machine  
 
If a high -complexity ophthalmic lens laboratory does not carry out rectification on its 
own premises, an outsourcing contract for this is required.  
 
If a laboratory does not have an anti -glare  machine, an outsourcing contract for this  is 
required.  
 
5.2.5 Contact lens laboratories must  have at least the following equipment:  
 
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 cont act lenses must  have the equipment listed in 
point  5.2.5 plus the following:  
 
a) Magnetic shaker  
b) Autoclave  
c) Laminar flow cabin  
d) Hydration, inspection, sterilisation, packing and packaging systems  
e) Sealing machine or stapler  
 
5.2.7 Ocular prosthesis laboratories must  have at least the following equipment : 
 
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, they must  also have torches or lighters.  
 
6. Maintenance and services  
 
6.1 Each item of equipment and instrument must  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, there must be a duly documented and recorded  programme of 
checks, calibration and preventive maintenance of  all equipment.  
 
6.2 One person must  be given o verall responsibility for the maintenance and calibration  
of equipment and instruments , or else there may be a maintenance department.  
 
6.3 The maintenance department may be in -house or sourced externally, in which case  
an appropriate contract must  be conc luded . This service must  take the following  points 
into account:  
 
a) An updated manual must be supplied containing written instructions for the 
preventive maintenance  of all machinery or equipment, and of the premises 
used by the various  departments.  
b) These in structions must  cover the method, frequency, recording procedures, 
etc. of the maintenance work and any repairs  of the machinery or  equipment.  
 
6.4 The sources of the different types of water, electricity and gas must  be properly 
maintained  to ensure that they deliver the  necessary quality 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, must  be kept under constant  
surveillance when in use to ensure that contamination from physical or microbe 
particles  does not exceed permitted levels, if applicable.  
 
6.6 The maintenance department must  take responsibility for the control of waste,  
residues and scrap.  
 
7. Storage and distribution.  
 
7.1 Storage areas must 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 must  be laid down in the written procedures and be checked and 
recorded.  
 
7.3 All m aterials arriving in the storage areas must  be identified and placed in 
appropriate  containers , ensuring that they are protected and that no contamination 
occurs.  
 
7.4 Quarantine areas and areas for approved materials must  be provided . All materials  
reject ed by quality control must  be so identified visibly pending their destruction.  
 
7.5 All supplies and products must  be stored in accordance with their particular quality  
requirements, and be clearly identified, tidy and stored separately; access to these  
areas must  be restricted.  
 
7.6 All materials and raw materials in storage must  be kept on storage units and/or  
shelving, avoiding contact with the ground.  
 
7.7 There must be w ritten procedures in the following areas:  
 
a) General procedure for the receipt, appro val 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  must  set out clearly all storage conditio ns and any special warnings 
required for  specific materials.  
d) There must be w ritten procedures setting out the distribution methods for 
products.  
 
8. Handling of supplies  
 
8.1 All raw materials , other materials  and supplies received by establishments affect ed 
by this resolution and which are to be used in the course of processing, adjustment,  
storage or dispensation as applicable, must  be subjected to testing immediately after 
receipt  and before use,  in accordance with established pro tocols . 
 
8.2 The purchas e of raw materials and supplies is an important process which must  be 
handled by staff with knowledge of the products and their suppliers. Raw materials  and 
supplies received by the establishments to which this resolution applies  and which are 
used in the processing and adjustment of prescription medical devices for  visual and 
ocular health must  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 manufactu rer. 
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 best before  date or date beyond which a further test is  
necessary.  
f) Identity of the supplier . 
g) Name and address of the manufacturer.  
h) Health regist ration  (where applicable).  
i) If no health regist ration  is required, the appropriate  analysis certificates.  
 
8.3 Only supplies authorised by the Head of Quality and which are still within their shelf 
life may be used.  
 
9. Packaging.  
 
9.1 The acquisition, handling and control of the raw materials for packing and printed  
packaging materials must  be carried out in the same way as for raw materials.  
 
9.2 Containers, packaging and labels must  be stored in secure conditions in order to  
prevent unauthorised persons from gaining access to them. Packing and packaging  
materials must  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 l abelling materials must  be destroyed and 
a record kept of the method of disposal.  
 
9.4 All stages of the packing and packaging process must  be carried out in accordance  
with written instructions in order to ensure uniform quality in line with the  applicabl e 
specifications.  
 
10. Quality management  
 
10.1 General principles  
 
This term refers to the set 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  for visual and ocular health, and must  ensure that they are fit for use, are 
suitable for  authorisation and do not pose  an additional risk for the user.  
 
Establishments must  dev ise, document, introduce and maintain a quality and 
continuous  improvement system.  
 
The quality management system must  guarantee the following points:  
 
a) That the quality system is staffed with people properly trained to carry out and  
coordinate all the nece ssary 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 a nnex.  
c) That manufacture, processing, adjusting, analysis, storage, distribution and/or  
dispensing  activities  are clearly specified in writing and that the requirements of 
this resolution  and its technical annex are adopted.  d) That the responsibilities of the managers 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 ocula r health are not 
dispatched  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 regularly evaluate the effectiveness 
and applicability of the ent ire quality management system.  
h) The quality system is required to examine and comment on products returned,  
and to decide whether they can be rectified or are to be destroyed . 
 
11. Quality control  
 
a) The establishment must  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 must  be undertaken on manufacturing, processing, adjustment,  
storage and distribution.  
c) Raw materials, semi -finished products and finish ed products must  comply with 
the manufacturer’s specifications.  
d) Quality control activity must  be based on an up -to-date procedures manual.  
e) The results of all quality controls and procedures must  be recorded.  
f) The appropriate equipment, instruments and suppl ies must  be available for the  
purpose of carrying out quality control activity.  
 
12. Documentation and files  
 
a) Establishments manufacturing and marketing prescription medical devices for 
visual  and ocular health must  ensure that a system of documentation is  
maintained for each  process carried out , at least during the first five (5) years as 
from the date of manufacture . 
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  of prescription medical devices for visual and ocular health 
devices are recorded. Registers must  be held and kept available for the period  
established in Article 25 of Law 594/2000.  
c) Information may be recorded using elec tronic data processing systems, 
photographic  systems or other appropriate methods.  
d) The establishment must  determine its procedures on the basis of its type of 
production  and of its organisational structure, and must  describe in detail the 
operations,  preca utions and measures to be adopted in the various activities.  
 
13. Complaints and claims  
 
a) Procedures must  exist for the receipt, handling and closure of complaints  and 
claims . 
b) The establishment must  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 must  be reported t o the health authority.  
d) One person must  be placed in charge of receiving, investigating and  responding 
to complaints.  
e) Every complaint must  be investigated, and such investigation must  be duly 
documented.  f) A complaints file must  be maintained; an appropriate  register must  be kept to 
record  complaints received by telephone.  
g) Periodic checks must  be carried out on complaints received in order to identify 
trends  and develop improvements in processes.  
  
TECHNICAL ANNEX No 2  
 
 
LIST OF PRESCRIPTION MEDICAL DEVICES FOR VISUAL AND OCULAR  
HEALTH.  
 
1. Prescription corrective or neutral lenses regardless of material, treatment, 
design or filter  used.  
2. Prescription frames.  
3. Prescription contact lenses, regardless of material, design, colour and methods 
of use,  and whether corr ective, neutral, therapeutic or cosmetic.  
4. Prescription orbital implants, ocular prostheses and other prosthetic 
accessories.  
5. Prescription stenopaeic eyeglasses.  
6. Prescription o ptical and non -optical aids for limited vision:  eyepieces , closed -
circuit  magnifi ers, loupes  and magnifying or  dioptric lenses.  
7. Devices for treating orthoptic and pleoptic problems: stereograms requiring 
dioptric  matching and lens filters with colouring on a specific wavelength.  
8. All prescription medical devices for visual and ocular he alth which may in the 
future  be used for ophthalmic purposes as a result of scientific and 
technological  advances,  as well as other devices as defined by I NVIMA  
(National Institute for Food  and Drug Monitoring).