Medical Devices Local Manufacturer and storing facility application form and checklist available on the website needs to be filled and provided to NHRA.
· Site Drawing/layout including surroundings and whether there are any flammables in the surroundings. The following needs to be included in the drawing/layout:
v Flow of the process - Site needs to be structured in a way that is systematic where the stages in the whole process do not overlap and goes smoothly. Flow example:
1. Raw materials
2. Production
3. Packaging and Labelling
4. Quality Control
5. Dispatch
v Raw materials storage
v Dispatch storage
v Administrative offices
v Staff break room
v Security of the factory such as access-controlled entrances.
v Location of sprinklers, Smoke detectors, Thermometers and any safety equipment.
· Ventilation and air curtain in order to prevent dust from entering. The Ventilation specification needs to be provided.
· Sprinklers and cameras for safety.
· Paint used should be anti-bacterial, anti-fungal, anti-flammable.
· Floor/Ground should be medical grade - anti-static, anti- flammable, anti-fungal and anti-bacterial.
· MSDS (Materials Safety Data Sheet) of Raw materials – Needed to know the safety equipment needed in the site as there might be a temperature that the machine needs to be at to avoid over heat or the type of Fire extinguisher needed in case of fire, etc.
· Backup generator is recommended but it is not a mandatory requirement.
Production machine requirements:
· Production Capacity per day.
· Pre installation requirements of the device. Needed to know for example the distance between the device and the wall or ceiling to decide whether the site size is suitable.
NHRA doesn’t have certain requirements or restrictions for the machine.
· Overview or description of the final product.
· Process of manufacturing
· Design and Development.
· Specifications (Including storage specifications that the final product needs to be stored in).
· Artwork (Label) sample. Points to include but not limited to:
o Manufacturer Name, full address, and contact details.
o Name of Medical Device.
o Type of Medical Device.
o Description.
o Lot/batch number.
o Model/reference number.
o Storage instructions such as single use, temp high and low, keep dry along with their symbols (Where applicable).
o Certifying body symbol or standard or CE mark.
o Quantity.
o If sterile, need to add sterile symbol.
o Instructions for use either on the artwork or on a separate leaflet.
o Contents (If applicable)
o Please refer to ISO 15223-1 standard and find the following templates to simplify the process and find the attached template to simplify the process.
· Raw materials should be medical grade.
The requirements of the quality assurance will be determined depending on the medical device. For example: The manufacturing of surgical masks should follow the EN 14683 Standard to ensure the product quality and safety and to be in compliance with international standards.
The manufacturing facility needs to include a trained employee for periodic preventive maintenance available at the site.
Management System:
· List of staff and their role. Example of needed roles:
o Projection Manager
o Project Manager
o Quality officer to check the final product.
o All staff should be aware of the ISO 13485 requirement and make.
· Policy and procedure (should be written and prepared as per ISO 13485 standard) for all processes including but not limited to:
o Raw materials management.
o Production line.
o Physical Quality Check.
o Packaging and Labelling.
o Storage management and dispatch management.
o Lab quality check.
o Post market surveillance.
· An IAF accredited notifying body should be contacted to obtain the Quality Management System certificate with the ISO 13485 standard which is to make sure that the quality of the manufacturing facility is being managed as per international standards. All staff needs to be fully aware of the requirements of documentation (policies, procedures and guidelines) and management for medical devices.