THAILAND TO REGULATE HAND SANITIZER AS A MEDICAL DEVICE

Thai FDA announced that hand sanitizer (alcohol gel) will require registration as a medical device (reference press released number สธ 1007/ว706 dated January 17, 2019). The change is expected to take place later this year when the new medical device classification guidelines are implemented.

Since 2011, hand sanitizer with alcohol content of 62.4% by weight or greater has required registration as a cosmetic device with the Bureau of Cosmetic and Hazardous Substances. When the new medical device classification system is implemented alcohol gel products will need to be registered with Medical Device Department of the Thai FDA.  At that time notified alcohol gel certifications issued by the Bureau of Cosmetic and Hazardous Substances will be cancelled.

The move to change the status of hand sanitizers was deemed necessary to prevent insufficiently strong products from being inappropriately used as a disinfectant in department stores, schools or hospitals to prevent the spread of contagious diseases.

PHILIPPINES NEW MEDICAL DEVICE REGULATIONS TO LAUNCH IN APRIL

Today the Philippines FDA provided important guidance related to the new Medical Device Regulations at a public forum held in Manila. The target date for implementation of AO 2018-0002 was announced for April 11, 2019. At that time, Class A, B, C and D medical devices will require a Certificate of Medical Device Notification (CMDN) in order to be imported and placed on the market in the Philippines. The grace period for compliance will be announced in March and expected to be 12 months.

Certificates of Product Registration (CPR) issued under the old Rules will remain valid until expiry at which point a license renewal application will generate a fresh CMDN. Certificates of Exemption (COE) issued under the old Rules will remain valid until an announcement by the FDA. The timing of this announcement has not yet been determined but likely to be several months to 1 year in the future. IVD devices are not affected by the new Rules.

Government processing fee for the CMDN will be based on the old Rules (e.g., US$175 covering five years) at first and then transition to the new risk-based fee structure floated back in July of last year (ref. article available here).

Official processing times will remain at 180 working days due to the high anticipated application volumes, however actual review times should be much faster.

Once implementation is made official, FDA will no longer accept applications for CPR or COE. However, any CPR or COE applications submitted prior to the implementation date will processed as normal.

Implementation of the new Rules is being conducted in phases. These changes represent Phase 0 and Phase 1 of the implementation plan announced in January of last year (copy of document available here ). Timelines for Phase 2 and 3 in which Class B, C and D devices will require the more comprehensive Certificate of Medical Device Registration (CMDR) have not yet been announced.

Important questions remain about classification, grouping, the validity of the products under COE, the management of the new fees, etc. Clarifications on these points are expected in March.

Asia Actual has a strong regulatory team in Manila to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.

HONG KONG OPENS THE VOLUNTARY REGISTRATION SYSTEM TO CLASS B & C IVD DEVICES

Today (February 11, 2019) the Medical Device Control Office (MDCO) opened the voluntary device registration system to Class B and C IVD devices. Previously only Class D (high risk) IVD devices were include under the Medical Device Administrative Control System (MDACS).

A copy of the Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices (GN-06E (2019) can be found here.

The regulatory systems for IVD and medical devices is currently voluntary in Hong Kong and now open all but and Class A IVD devices Class I medical devices.

Manufacturers typically participate in the voluntary system to (1) gain a sales advantage as the Hospital Authority requires or gives preference to registered devices in public hospital purchasing decisions and (2) avoid confusion and delays that will come when the system becomes mandatory. To date more than 5,000 devices have been registered by the MDCO under the voluntary system.

Asia Actual has a office in Hong Kong staffed by experienced regulatory professionals. Please contact us with questions or support
requests.

INDIA REQUIRES MORE NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017

India’s Central Drugs Standards Control Organization (CDSCO) has officially added eight more medical devices to the list requiring registration. The new additions are:

(1) X-ray machines,
(2) CT scan equipment,
(3) MRI equipment,
(4) PET equipment,
(5) defibrillators,
(6) dialysis machines,
(7) bone marrow cell separators,
(8) all implantable medical devices.

Manufacturers and Importers of products under these categories need to immediately apply for import licenses in Form MD-14 of the Medical Device Rules, 2017. Products without valid registrations may not be imported and marketed after April 1, 2020.

The mandate was published in the Gazette of India on February 8th, 2019 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy.

The resolution to regulate this list of devices was originally raised 10 months earlier at the May 16th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact us here with questions or service inquiries.

INDIA OFFICIALLY REQUIRES FIRST NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017

India’s Central Drugs Standards Control Organization (CDSCO) has officially added four medical devices to the list requiring registration. The four new additions are:

(1) glucometers,
(2) blood pressure monitoring devices,
(3) nebulizers, and
(4) digital thermometers.

Manufacturers and Importers of products under these categories need to immediately apply for import licenses in Form MD-14 of the Medical Device Rules, 2017. Products without valid registrations may not be imported and marketed after January 1, 2020.

The mandate was published in the Gazette of India on December 3rd, 2018 by the Ministry of Health and Family Welfare (Department of Health and Family Welfare). The published announcement constitutes Gazetting, officially implementing the new policy. The resolution to regulate this list of devices was originally raised 5 months earlier at the July 25th, 2018 Drugs Technical Advisory Board (DTAB) meeting.

It is worth noting that prior DTAB meetings yielded announcements that various other devices would soon require registration. However, since, they have not been Gazetted to date.

Asia Actual has a strong regulatory team in India helping companies stay informed and navigate the regulatory changes in India’s dynamic and complex market. Please contact us here with questions or service inquiries.

NEW OFFICE SPACE FOR ASIA ACTUAL THAILAND

Asia Actual is excited to announce the dedication of our new office space in the Bangkok. Mr. Binh Thai, General Manager at Asia Actual Thailand, commented, “We have sought to establish a comfortable, modern space to provide a safe and productive environment for our employees and visiting clients.” The investment reflects the company’s commitment to the Thai market and expectations for growth in demand for high quality regulatory, importing and commercial support from multinational medical device manufacturers.  Come visist us soon at:

No. 173, Asia Centre Building, South Sathorn Road

Thung Maha Mek Sub-District, Sathorn District

Bangkok 10 10120  Thailand

Tips for Importing Medical Devices into Thailand

Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.

Unique to the customs clearance process for medical devices in Thailand is the requirement for a License Per Invoice (LPI) approved by the Thai FDA for each shipment. The Import License holder must apply with credentials, the original Import License, and original shipping documents (e.g., Air Waybill, shipping invoice and packing list) submitted online to Thai FDA. (The one-time fee to the TFDA for LPI submission which includes the Stamp Duty, Power of Attorney, and document submission). The FDA will confirm that all devices included in the shipment (by part number) are covered by a valid import license and then issue the LPI.  The application review process take 1 to 2 days.  The resulting License Per Invoice document is a required element of the customs clearance process for registered medical devices, accessories and spare parts.

The overall process is then similar as in other countries with assemble a submission of shipping documents, payment of import tax (if any depending on HS code), payment of VAT (7% on all goods and services), etc.  Shipping rate will vary significantly by mode and point of origin; and should be known to manufacturers.  Customs Clearance charges should not exceed 1% of Cost of Goods.

A source of common delays can be:

  1. discrepancies or inconsistency with HS Code (when using different Freight Forwarders)
  2. inconsistency between shipments with the value of goods
  3. delayed LPI application filing
  4. Shipments containing expired and valid items as Customs does not allow for partial clearance.
  5. Shipments containing parts from different manufacturers.

Ms. Pratabjai (Ann) Panuchaklap is responsible for managing the importation process at Asia Actual.  She has been managing supply chain logistics in Thailand for more than 20 years with a specialization in medical devices and pharmaceuticals.

Using Asia Actual as your License Holder in Thailand comes with the added benefit of expertly managed, efficient and transparent importations.

Contact us for more information on our importing servcies.

Indonesia Medical Device e-Catalogue Enrollment: 2018 Debrief

Access to the public hospital on-line procurement system, e-Catalogue, is an important part of a successful sales strategy in Indonesia for most medical and diagnostic devices. At the same time, navigation of the enrollment process is a challenge for many manufacturers and distributors. To be positioned for successful e-Catalogue listings, it is important to understand the submission process and to anticipate expected changes for 2019.

The e-Catalogue system in Indonesia is managed by the LKPP (The Government Agency for Procurement of Goods & Services).

Application Deadlines

On March 26th the LKPP released the enrollment schedule for 2018 with the deadline for application submission set at April 20th. Applicants had just 20 working days to prepare. Successful applicants were notified on April 30th.  Price negotiation meetings were to be completed by May 4th, but due to high application volumes the deadline has been extended through December 2018. This was a much-accelerated schedule compared to previous years.

Eligible Products List

At the same time three, separate lists were published identifying 613 categories of eligible devices. Enrollment eligibility has varied over the years from first-in-first-out open enrollment from 2014 to 2016; to periodic by-invitation-only from 2016 to 2017; to the current mass enrollment one-time per year established in 2018.

Required Documents

The list of documents required for the e-Catalogue application for medical devices has changed several times making advanced preparation difficult. (The latest version is the LKPP 5th schedule published on June 7, 2018.) Verification of application documentation is very strict, and many applications have been rejected for non-compliance. Particularly challenging is getting authentication of the Distributor Appointment Letter (Surat Tanda Pendaftaran, or STP) by the Ministry of Trade at the Indonesia Consulate in country of origin due to processing time requirements.

Pricing

Price negotiations seem to be restricted to between 20% and 40% of the Landed Cost of a device (inclusive of CIF charges). The range depends on effective justification of the support effort and costs. Sufficient time should be budgeted for e-Catalogue pricing strategy consideration and negotiations preparation.

2019 Enrollment

In 2019 significant changes are expected for e-Catalogue enrollment for medical and diagnostic devices with management being shifted from the LKPP to the Ministry of Health. The next intake is expected in July 2019 with what may be open enrollment for all product categories. Distributor markup is anticipated to be fixed at 1.4 times Landed Cost.

Manufacturers should begin now to register devices of interest for e-Catalogue listing choosing their local Indonesia Agent carefully. It is important to prepare applications early according to current requirements and stay vigilant any additional changes.

Asia Actual‘s experienced staff in Jakarta is available to respond to questions and support requests.

India to Regulate Glucometers, Blood Pressure Monitors, Nebulizers and Digital Thermometers

At the July 25th Drugs Technical Advisory Board (DTAB) meeting, a resolution passed to add (1) glucometers, (2) blood pressure monitoring devices, (3) nebulizers, and (4) digital thermometers to the list of notified medical devices requiring registration with the Central Drugs Standards Control Organization (CDSCO) in India.

Next the Ministry of Health and Family Welfare must issue a Gazette Notification for the requirement to become official. Based on past experience,  it is expected to take approximately 5 months from a positive DTAB board resolution to Notification with a likely 12-month transition period for compliance. Manufacturers of these devices should take urgent action to prepare registration applications to maintain access to the Indian market.

This is the third Notification announcement since the Medical Device Rules, 2017 were enacted on January 1st of this year. The decisions are coming with increased frequency, so manufacturers of non-Notified devices are advised to stay alert for announcements and make early registration preparations.

Asia Actual has a strong regulatory team in Delhi to help companies stay informed and ahead of regulatory changes.

We also provide efficient, transparent management of medical device regulatory, vigilance and importing activities in this dynamic market.

Please contact us with questions or service inquiries.

Indonesia Tightens Enforcement of Medical Device Licensing

With the implementation of Regulation No. 60, 2017 on February 1st, 2018 the Indonesia government tightened enforcement of medical device licensing requirements.

Formerly, compliance for imported medical devices was confirmed during the customs clearance process by Customs and Excise Department officials. Now the Ministry of Health is authorized to extend confirmation through inspection at medical device distributors (AKA, Post-Border monitoring).

Any devices without proper licensing may result in re-exportation or destruction at the importers expense. Further, distributors in possession of improperly licensed devices may have their Distribution License suspended.  The move is expected to increase compliance with the medical device registration requirements.