SIRIM FACE MASK TESTING (MEDICAL AND NON MEDICAL)

 

SIRIM QAS is ready to assist manufacturers and suppliers meet increasing demand for quality and safe products in the market. Our testing and certification cover a wide range of face masks and respirators, helping companies to ensure product compliance with national and international standards.

Face masks and respirators are expected to provide essential protection to the user from any infectious agents or hazardous airborne particles. Apart from application in the healthcare and industrial sectors, the use of masks for the public becomes imperative during haze, pandemics and epidemics.

Substandard quality of masks therefore could cause a serious risk to the public health and safety.  Therefore, testing and certification can help ensure standards of quality are maintained by manufacturers and suppliers of these products.

SIRIM QAS is a one-stop centre for testing and product certification for face masks. We have the expertise and capabilities to perform testing on a wide range of face masks and respirators based on relevant international standards. 

Product certification with SIRIM QAS is proof that the products you put out in the market are of superior quality, and grants you a competitive edge in the PPE industry. This also enables acceptance of your products to international markets through compliance with national requirements.

Scope of Services

Non-medical Face Masks

The Domestic Trade and Consumer Affairs Ministry  gazetted Trade Descriptions (Certification and Marking of Non-Medical Face Mask) Order 2022. (download here) 

The order will take effect on 1st January 2023 to ensure that non-medical face masks, whether produced locally or imported, comply with the set safety standards.  The manufacturers and importers of non-medical face masks must apply for MS SIRIM certification and marking from SIRIM QAS International Sdn. Bhd.

Reusable masks are seen as a more economical and environmentally friendly alternative to disposable masks. They are generally used for non-medical purposes but should meet minimum requirements to protect the user from transmission of infectious agents.

Standards applicable for non-medical face masks are either SIRIM 40, CWA 17553 or AFNOR SPEC S76-001.

Relevant performance testing offered by SIRIM QAS includes Breathability, Microbial Test, Particle Filtration, Flame Spread, Cleaning and Ear Band.

Respiratory Protective Devices

Respirators are tight-fitted masks designed to protect the users against particles which include gasses, dust, droplets and aerosols. This type of masks are normally used in various industrial sectors and can be considered as Non-Medical Face Mask as well SIRIM QAS can test and certify on various types of respirators based on relevant standards e.g MS 2323 or BS EN 149

Medical Face Masks

Medical face masks are used by healthcare professionals and patients to protect them from exposure to infections, blood and bodily fluids.  Under Medical Device Act 2012 (Act 737) requires a medical device to be registered under the Act before it can be imported, exported or placed in the market (www.mda.gov.my).  In addition, applicant may apply SIRIM Product Certification to put SIRIM label on the product as form of quality recognition in the eyes of general public.

There are three types of medical face masks:

• Type I are used for patients in order to reduce the risk of the spread of infections, especially during pandemics and epidemics
• Type II are used by healthcare workers and front liners for similar intended purposes when contact to blood or bodily fluids are not at risk
• Type IIR are appropriate for use by healthcare professionals where exposure to blood and/or bodily fluids are at risk

1/2/3 ply masks are Type I medical face masks that have a lower bacterial filtration efficiency compared to Type II masks. Type IIR medical masks have similar applications as Type II but carry additional properties of splash resistance.

SIRIM QAS is capable to carry out testing for all the above types of medical masks based on the international standard BS EN 14683, which covers:

• Bacterial Filtration Efficiency (BFE)
• Differential Pressure
• Splash resistance pressure (Synthetic Blood)
• Microbial Cleanliness (Bioburden)
• Biocompatibility

SIRIM may also certify to other equivalent medical face masks standard e.g. ASTM F2100

Application Process

Certification

1. Enquiries
2. Issuance of Quotation
3. Application
4. Document Evaluation
5. Initial Audit
6. Sample Selection and Testing
7. Recommendation and Approval
8. Purchase of SIRIM Label
9. Surveillance Audit
10. Renewal

Testing

1. Submission of Test item
2. Issuance of Quotation
3. Product Testing
4. Issuance of Test Report

Application Forms

Local Manufacturer

• Product Certification Application Form
• Declaration of Approval from Relevant Authority
• Declaration of Approval for Trade Mark or Brand Name
• Authorisation Letter of Trade Mark (if applicable)

Trading Company for Foreign Manufacturer

• Product Certification Application Form
• Declaration by Manufacturer
• Declaration of Approval for Trade Mark or Brand Name
• Authorisation Letter of Trade Mark (if applicable)

Foreign Manufacturer

• Product Certification Application Form
• Declaration of Approval for Trade Mark or Brand Name
• Authorisation letter of Trade Mark (if applicable)

CLINICAL STUDY IN MALAYSIA

Clinical Trial/ Study is important for the development of a medical devices whereby it give the conformance of product safety and performance with regard to use with human.

1. Great infrastructure in the specialties such as:

   a. Cardiology,

   b. Gastroenterology,

   c. Respiratory,

   d. Oncology, and

   e. Endocrinology.

2. Government supportive regulatory to make Malaysia a preferred clinical research destination

3. Regulatory and ethics submission document language of both malay and english

4. Parallel and fast approval timelines

5. Quick start-up timelines

6. Lower per-patient costs and Institutional Review Board (IRB) fees compared to most countries

7. Medical device and non-interventional studies require only Institutional Ethics Committee (IEC) approval

Landscape of Malaysian population

32 million people, of which Malays and Indigenous (60%), Chinese (28%), Indian (8%), and others

72.8% reside in urban centers

95.4% literacy rate

Malaysia has a wide ethnic population as above, which helps in testing the drug in multiple ethnic groups.

Malaysian government initiatives

The government of Malaysia, with an aim to promote and increase the number of clinical studies in the country, established Clinical Research Malaysia (CRM) in 2012. The objectives were to effectively increase the speed, reliability, and delivery of outcomes.

Clinical trial status in Malaysia

A total of 1,490 clinical trials are conducted in Malaysia with 374 ongoing studies as per clinicatrials.gov. (Data as of April, 21), and this shows the interest of researchers to perform their clinical trials in Malaysia.

Therapeutic areas for clinical trials in Malaysia

Currently, the major therapeutic areas to perform clinical trials in Malaysia are:

Heart disease and Stroke

Influenza and Pneumonia

HIV/AIDS

Tuberculosis

Diabetes

Recent achievements of the clinical trials in Malaysia

Clinical trials of new Hepatitis C combination treatment held in the country have shown not only a high 97% cure rate but also better efficacy of treating the most severe form of Hepatitis.

Hospital Miri, Sarawak has been the 2nd top recruiter globally for a respiratory study recently.

Hospital Kuala Lumpur was among the top 2 recruiters for a Cancer Registry study in Asia.

The government signed MoU’s with CROs to attract more global trials into the country.

Need support to conduct your clinical trial in Malaysia?

Regulatory for clinical trials in Malaysia

There are mainly two agencies regulating clinical trials in Malaysia

a. National Pharmaceutical Control Bureau (NPCB) or 

b. Medical Device Authority (MDA)

Agencies reviewing the clinical trials

Institutional Review Board (IRB)s, including the Medical Research & Ethics Committee (MREC) for trials using the Ministry of Health (MOH) Malaysia facilities or

Local IRBs for non-MOH facilities.

The National Pharmaceutical Regulatory Agency (NPRA) ensures the quality, efficacy, and safety of pharmaceuticals. Additionally, it also acts as a secretariat to the Drug Control Authority (DCA), which

Clinical trial approval process

Following the guidelines for CTIL/CTX, the CTIL/CTX applications are submitted to the NPRA.

The NPRA screens the application dossier for completeness before handing them over to the DCA to make a decision.

PI/CRO/sponsor, who intends to submit to MREC, needs to register in the National Medical Research Register (NMRR) website and get a user account. This user account can be used for all submissions thereafter.

CTIL/CTX application is processed in 30 working days, while the MREC approval process takes 50 working days (if no amendments to the submitted documents are required).

Both CTIL/CTX and MREC applications can be submitted in parallel.

If the DCA and MREC grant approval (or other accepted IRB/IEC), then the NPRA issues the CTIL/CTX and regulatory approval letters to begin the clinical trial.

POST MARKET FOLLOWUP CLINICAL STUDY (PMFCS)

 

CLICK TO GO TO GUINDANCE  MDCG-2020-7 LINK

KLASIFIKASI PRODUK BARANGAN PERUBATAN (MEDICAL DEVICE) - MDR 2017/745

 

sila KLIK SINI untuk lihat dokumen panduan.

PENDAFTARAN CE MARKING MDR 2017/745

 

Pendaftaran CE marking terbaru berdasarkan panduan dokumen perundangan terbaru daru "EU Authority" telah menggantikan MDD 93/42/EEC kepada panduan baru iaitu MDR 2017/745.

Perubahan ini menyentuh banyak elemen-elemen didalam keperluan pematuhan untuk pendaftaran barangan peranti perubatan (medical device) dari pelbagai sudut. 

Antara perubahan ketara adalah keperluan kepada pendaftaran kepada sistem pendaftaran secara talian, EUDAMED. Melalui sistem ini, semua barangan peranti perubatan akan perlu memastikan beberapa maklumat tambahan, dokumen-dokumen keperluan baru, panduan-panduan baru yang perlu dipatuhi dan sebagainya.

Klik sini untuk rujuk dokumen perundangan berkenaan peranti perubatan (medical device) terbaru MDR 2017/745.

MDR 2017/745 link