We are YOU Centred. Stay in control. We get you certification ready in 30 to 90 days with 100% compliance.
We are an organization in Malaysia specially established to provide consultation, training and technical support services in all aspects related to management system. As one company offers process, technical and system focused management expertise, maintain good track record in the field of various management system, business improvement and other value-added services such as government grant application.
We develop fully customized quality, safety, and environmental management systems making certification easier and saving a lot of time and money. Most clients certified within 90 days, sometimes 30 days.
WHO IS ISO?
ISO is the International Organization for Standardization ISO is not an acronym for the company name however; ISO is derived from the Greek word isos which means equal. The ISO develops standards, which include requirements, specifications, guidelines, or characteristics that can be universally applied and consistently used to ensure that products, materials, services, and processes are up to par for their purpose. These international standards are set to bring coordination and unification of industries.
It is wise to invest in ISO Certification for your business to keep up to date on the latest specifications for products, services, and good practice. The standardizations connect companies worldwide, breaking barriers to improve international trade and consensus. The ISO has developed more than more than 19,500 standards that cover every aspect of business and technology. ISO is not involved in the accreditation or certification process.
The ISO 9001 – Quality Management Standard:
ISO 9001 is the most sought-after and internationally acclaimed management system standard. Internally, the ISO 9001 Quality Management Standard helps to improve operational and management efficiency and effectiveness.
ISO 9001 is not a mere Quality Assurance Standard or a degree of excellence; it is about ensuring customer requirements are met with consistency. Attaining ISO 9001 certification makes your business more valuable. Certification assures others that your organization is committed to continually improving systems to better ensure customer satisfaction. Other organizations are more likely to engage with ISO 9001 certified companies. Moreover, ISO 9001 Quality Assurance Certification demonstrates credibility.
While there were earlier standards for quality management systems, the International Organization for Standardization or ISO released its 9001 standard in 1987 for the first time. The standard has been revised several times in 1994, 2000, 2008, and the current version in 2015.
An internationally and diverse selection committee developed the framework of the ISO 9001 Quality Management System Standard to help all types of organizations (including commercial businesses, governments, non-profit organizations, etc.) adopt “good management practices.”
ISO 9001 is packed full of good management practices that every good organization should have. These practices include:
ISO 13485 – Medical Devices Quality Management Systems (MDQMS)
Some regulators around the world directly require certification to ISO 13485. While this is not currently a requirement in the US, there is a US law that is similar in almost all aspects to ISO 13485, which is 21 CFR Part 820. Most US companies looking to send product outside of the US will also get ISO 13485 Certification.
Putting the regulatory considerations aside, implementing an ISO management system standard into your business represents good management practice, or in the case of medical devices “Good Manufacturing Practice [GMP].” By implementing ISO 13485, an organization becomes a better bet for their suppliers. Not only they have implemented important controls directly related to medical device manufacturing, but also they have provided efficiencies and effective management through:
↪️ A documented approach to management | ↪️Policies, objectives, and planning | ↪️Control of documents | ↪️Control of records | ↪️Reviews | ↪️Internal audits | ↪️Product non-conformances and continual improvement
Medical Devices Authority
The Malaysian medical device registration process
If your device is approved in one of the recognized reference markets (US, European Union, Australia, Japan or Canada), you can leverage this approval and follow a simplified registration process as outlined below. Here are the basic steps:
- Determine your classification. Medical devices are classified as Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (highest risk), similar to the classification scheme used in the European Union.
- Appoint an in-country Malaysia Authorized Representative to manage your device registration.
- Prepare an abridged Technical File including your reference country approval, test reports, Malaysian Essential Principles checklist, Malaysian Declaration of Conformity, QMS Certificate, etc. Use ASEAN Common Submission Dossier Template (CSDT) format technical file.
- Request a technical review of your documentation by a licensed Conformity Assessment Body (CAB).
- After satisfactory audit by CAB, the verification Certificate is issued.
- Submit application with CAB certificate and audit report to MDA.
- MDA begins review. Application will be returned with 90 days to respond for any additional information requests.
- Upon satisfactory review, MDA grants the registration.
Asas Niaga Consultancy can help register your MDA in Malaysia
We can assist with your registration and interact with the Medical Device Authority on your behalf. Here’s how we can help:
- Our team of expert consultants in the US and Malaysia allows us to efficiently register your devices and interact with the MDA on your behalf.
- We are fully capable of acting as your Malaysia Authorized Representative if you have no local office in the country or simply wish to outsource the regulatory functions of a local office.
- We can help you access other medical device markets in Southeast Asia according to your business strategy.
Why is CE Marking certified required?
Responsibility for CE marking lies with whoever puts the product on the market in the EU, i.e. an EU-based manufacturer, the importer or distributor of a product made outside the EU, or an EU-based office of a non-EU manufacturer. The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out a conformity assessment, set up a technical file, and sign a Declaration stipulated by the leading legislation for the product. The documentation has to be made available to authorities on request.
Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Importers should also make sure that contact with the manufacturer can always be established. Distributors must be able to demonstrate to national authorities that they have acted with due care and they must have affirmation from the manufacturer or importer that the necessary measures have been taken.
If importers or distributors market the products under their own name, they take over the manufacturer’s responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking.
There are certain rules underlying the procedure to affix the marking:
▪️Products subject to certain EU directives or EU regulations providing for CE marking have to be affixed with the CE marking before they can be placed on the market.
▪️Manufacturers have to check, on their sole responsibility, which EU legislation they need to apply for their products.
▪️The product may be placed on the market only if it complies with the provisions of all applicable directives and regulations and if the conformity assessment procedure has been carried out accordingly.
▪️The manufacturer draws up an EU declaration of conformity or a declaration of performance (for Construction Products) and affixes the CE marking on the product.
▪️If stipulated in the directive(s) or regulation(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure or in setting up a production quality system.
▪️If the CE marking is affixed on a product, it can bear additional markings only if they are of different significance, do not overlap with the CE marking and are not confusing and do not impair the legibility and visibility of the CE marking.
Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a notified body, is of great importance throughout the entire CE-marking process, from design verification, and set up of the technical file to the EU declaration of conformity.
HACCP (HAZARD ANALYSIS CRITICAL CONTROL POINT)