Monthly Archives: November 2017

On August 14th, 2017 the Indonesia National Agency of Drug and Food Control released a safety circular following safety assessments conducted on certain hair coloring products and sunscreens containing methylisothiazolinon, deoxyarbutin, alpha arbutin, beta arbutin or plastic microbeads. In summary:

1. The usage of deoxyarbutin, alpha arbutin and beta arbutin in cosmetics will be monitored and will require additional documentation during the notification process:
   a. A hydroquinone testing report
   b. A product stability study
   c. A clinical study on in-use stability
   d. Storage condition information included in the label
2. The methylisothiazolinone maximum concentration in rinse-off cosmetic products will be reduced from 0,01% to 0,0015%
3. The benzophenone maximum concentration in sunscreen products will be reduced from 10% to 6%
4. The addition of titanium dioxide and zinc oxide in nanomaterial dosage form as an active ingredient in sunscreen will be restricted
5. Use of coating materials (in nanomaterial dosage form) in sunscreens must be safe and not compromise the sunscreen effect
6. The addition of a warning label stating “DO NOT USE FOR EYELASH AND EYEBROW COLORING” on the packaging of all hair coloring products is required
7. Plastic microbeads will be banned in rinse-off cosmetic products

The Philippine Association of Medical Devices Regulatory Affairs Professionals (PAMDRAP), is a not-for-profit association composed of regulatory affairs professionals representing medical device companies, and is recognized by the Philippine FDA Center for Device Regulation, Radiation Health and Research (CDRRHR).

The vision of the Philippine Association of Medical Device Regulatory Affairs Professionals is to improve the medical device industry within the country by organizing and uniting regulatory affairs professionals, and by liaising with the appropriate government agencies on behalf of its members to ensure the seamless implementation of medical device regulations in the Philippines. Aligned with this, the association conducts annual scientific meetings to update its members on any changes to local medical device regulations. The 13th General Membership Meeting of the Philippine Association of Medical Device Regulatory Affairs Professionals took place on November 29, 2017 from 7:00 am to 5:00 pm at Joy Nostalg Hotel and Suites Manila. Invited speakers were from the medical device technical committee of the FDA CDRRHR and from the Equipment Standard Division of NTC.

The scientific meeting covered the following topics:

• The Continuing Professional Development (CPD) Law of 2016 and it requirements
• Current updates on in-vitro diagnostics regulations in the Philippines
• FDA updates on new circulars, medical device risk classification and the common submission dossier template (CSDT) implementation
• National Telecommunication Commission (NTC) regulations particularly those relating to products that utilize WiFi, Bluetooth etc.

The Election Committee of the Association will also conduct elections for the Board of Trustees for the year 2018 – 2019. Members of the association have the sworn duties to exercise the right to vote for the new set of officers who will lead the Philippine Association of Medical Device Regulatory Affairs Professionals for the next two years together with their proposed plans. Afterwards, PAMDRAP organizes a Christmas party for its members. Andaman Medical Philippines is a member of PAMDRAP and took part in this scientific meeting to obtain updates, and promote good compliance with the health authorities’ rules and regulations.

Source:
Philippine Association of Medical Device Regulatory Affairs Professionals Official 13th General Membership Meeting (http://www.pamdrap.org/)

Concentrated products for hemodialysis have been reclassified from Class III General Medical Devices to Class II Notification Medical Devices by the Ministry of Public Health in Thailand. This regulatory change came into effect on 31 October 2017.

This regulatory change is aligned to international medical device standards for the classification of concentrated products for hemodialysis. To protect consumers’ safety, it is recommended that intensive products for hemodialysis are prescribed – a medical device that requires a detailed list and defined rules, procedures and conditions for control.

According to Section 5, Section 6 (2) (4) (5) and (13), Section 44, Paragraph 2 and Section 45, Paragraph 2 of the Medical Device Act BE 2551,  “Concentrate for haemodialysis”  is defined as  “a mixture of chemicals and water, or a mixture of chemicals in the form of a powder or other highly concentrated media, which is used as a reagent during haemodialysis”.

Clause 3 of the aforementioned Medical Device Act states that “concentrated products for hemodialysis should be standardized”. The requirements of “ISO 13958: 2009 Concentrates for hemodialysis and related therapies” or the newer national standards “ANSI / AAMI RD 52: 2004 Dialysate for Hemodialysis” or other equivalent standards should be adhered to. Concentrated products for renal dialysis imported prior to this announcement, can be sold until the expiry date of the certificate of approval.

Concentrated products for hemodialysis have been reclassified from Class III General Medical Devices to Class II Notification Medical Devices by the Ministry of Public Health in Thailand. This regulatory change came into effect on 31 October 2017.

This regulatory change is aligned to international medical device standards for the classification of concentrated products for hemodialysis. To protect consumers’ safety, it is recommended that intensive products for hemodialysis are prescribed – a medical device that requires a detailed list and defined rules, procedures and conditions for control.

According to Section 5, Section 6 (2) (4) (5) and (13), Section 44, Paragraph 2 and Section 45, Paragraph 2 of the Medical Device Act BE 2551,  “Concentrate for haemodialysis”  is defined as  “a mixture of chemicals and water, or a mixture of chemicals in the form of a powder or other highly concentrated media, which is used as a reagent during haemodialysis”.

Clause 3 of the aforementioned Medical Device Act states that “concentrated products for hemodialysis should be standardized”. The requirements of “ISO 13958: 2009 Concentrates for hemodialysis and related therapies” or the newer national standards “ANSI / AAMI RD 52: 2004 Dialysate for Hemodialysis” or other equivalent standards should be adhered to. Concentrated products for renal dialysis imported prior to this announcement, can be sold until the expiry date of the certificate of approval.

The Asian Harmonization Working Party (AHWP) is a non-profit organization established to research and recommend ways to harmonize medical device regulations in Asia and other regions. The AHWP works in close collaboration with the Global Harmonization Task Force, APEC and other related international organizations aiming to consolidate requirements, procedures and standards.

This year the 22nd AHWP Annual Meeting will be held in New Delhi, India from 4th to 8th December 2017.

Updates on Medical Device Regulations in India, Singapore, Japan, South Korea, Australia, South Africa and a range of other topics including information on the Medical Device Single Audit Program and requirements for clinical investigation and evaluation for medical devices are expected to be shared during the workshop.

For more information on theAsian Harmonization Working Party workshop, visit the AHWP website.